FDA-cleared prescription digital therapeutics

1. Introduction

Version followed: US FDA authorisations and the indication wording reported by FDA, the manufacturers and trade press between November 2020 and November 2025; regulatory status summarised as of October 2026 per the sources listed. Status of these products changes often (see Pear Therapeutics below), so re-check each product's current labelling, availability and ownership before every new prescription or referral.

Prescription digital therapeutics (PDTs) are software medical devices that the FDA has authorised for a named condition, age group and use, and that are available only on the order of a licensed clinician. They are not a single therapy but a regulatory category: each product packages a psychological or cognitive method (CBT, CBT for insomnia, cognitive-emotional training, an attention-targeting video game, a nightmare-interrupting smartwatch) into a standardised digital course. The implied model of change is the model of the method inside the app (for example, learning and practising CBT skills, or repeated training of attention), delivered at scale with consistent fidelity. Almost all of these products are labelled as an adjunct: to usual care, to clinician-managed outpatient care, to medication, or to a wider treatment programme. The psychotherapist's work is therefore to judge fit, support informed choice, weave the app's content into therapy, monitor for deterioration and adverse effects, own the crisis pathway (the apps do not), and help the client end the course without over-reliance. [source: Big Health FAQ; Otsuka press release; NightWare FDA announcement as reprinted by News-Medical; Curio press release via BioSpace]

For CBT for insomnia itself (including SleepioRx's content and Somryst), see guide 090. For video-game-based therapy more broadly, see Domain VIII guide 178; EndeavorRx is covered here.

Product status at a glance (as of October 2026)

Current commercial availability of each product in October 2026 is [uncertain]; the table gives the last reported regulatory and ownership position, not proof that a product can be ordered today. Big Health's FAQ describes a live ordering route for SleepioRx and DaylightRx (a provider ordering website with unique patient access codes) [source: Big Health FAQ]. PursueCare describes delivering reSET and reSET-O through its own programmes and partner clinics [source: PursueCare release, October 2024]. Akili's 2023 move away from a prescription focus makes EndeavorRx availability especially worth checking [source: MedTech Dive, May 2024]. Status outside the US (EMA/CE marking, NICE, German DiGA listing) is [uncertain]; do not assume a US clearance applies elsewhere.

Pear Therapeutics' 2023 bankruptcy and what happened to its products

Pear Therapeutics (founded 2013) filed for Chapter 11 bankruptcy in April 2023 after a falling share price, layoffs and losses; its assets were auctioned for about USD 6.05 million in total (reported 19 May 2023). Nox Health bought the Somryst (CBT-I) assets; Harvest Bio, led by Pear's former CEO, bought reSET, reSET-O, PearConnect, the corporate trademarks and pipeline assets; Click Therapeutics bought platform patents; Welt bought migraine assets. [source: mobihealthnews, May 2023] Harvest Bio later sold reSET and reSET-O to PursueCare, a telehealth addiction provider, which relaunched both under their original names, first within its own programmes with plans to offer them to other providers; pharmaphorum notes PursueCare is taking on the reimbursement challenge Pear had cited. [source: pharmaphorum, October 2024] What happened to individual patients mid-course when Pear wound down is not documented in the sources used here [uncertain: not verified].

Practical lesson [synthesis]: a cleared product can disappear, change owner, change access route or lose support within weeks. Treat any PDT as a component that might stop, and keep the therapy plan able to stand without it.

Coverage

• Medicare: CMS created three Digital Mental Health Treatment (DMHT) billing codes (G0552, G0553, G0554), effective 1 January 2025; coverage is not guaranteed; the practitioner must purchase the licence and furnish it to the patient (free products are not reimbursed); traditional Medicare patients typically owe 20% coinsurance; Medicare Advantage, commercial and Medicaid cost-sharing depend on the plan. [source: Big Health FAQ]
• The CY 2026 Physician Fee Schedule final rule (effective 1 January 2026) expanded the DMHT codes to devices used to treat ADHD, and declined to extend them to gastrointestinal or fibromyalgia devices. [source: Sidley Austin update, November 2025] Big Health notes that the DMHT codes do not guarantee reimbursement, that the provider must incur the device cost (free products are not reimbursed), and that traditional Medicare applies 20% coinsurance to practitioner services. [source: Big Health FAQ] The detailed billing conditions (treatment plan, supervising practitioner) are [uncertain]; check the CMS fee schedule text.
• Commercial and Medicaid coverage is uneven; Pear's commercial failure is widely linked to reimbursement difficulty (pharmaphorum). Akili's revenues were small before its sale (mobihealthnews). [source: pharmaphorum; mobihealthnews]

2. Framework

This is a framework for the psychotherapist's work around a PDT course, not a protocol the manufacturers publish [synthesis, built on the labelling points cited].

Phase 1: Assessment and fit (one to two sessions, can sit inside ongoing therapy). Goals: confirm the diagnosis matches a cleared indication; confirm age falls within the label; screen for stated exclusions (for example, MamaLift Plus is not appropriate for severe depression or anxiety, serious mental illness, psychosis or suicidal thoughts; NightWare is not for people who act out during nightmares; reSET-O presumes buprenorphine treatment and contingency management in an outpatient programme); check practical suitability (Big Health lists understanding conversational English, having a smartphone, stable physical and mental health, and comfort with basic technology). Move on when the client meets the label, has no exclusion, understands that the app is an adjunct, and wants to try it. [source: Biospace/Curio; News-Medical/FDA; K173681 record; Big Health FAQ]

Phase 2: Shared decision, consent and ordering (one session). Goals: informed choice (what the product does and does not do, data use, costs, who to call in a crisis), then the order. Big Health lists psychiatrists and other physicians, clinical psychologists, clinical social workers, nurse practitioners, physician assistants, marriage and family therapists and mental health counsellors as eligible prescribers within their scope; for other products the sources say only "healthcare provider" [uncertain which professions may order Rejoyn, MamaLift Plus, NightWare, EndeavorRx or reSET]. Rejoyn's indication also assumes an antidepressant prescriber; reSET-O assumes a buprenorphine prescriber and programme. Move on when the order is placed and the client has activated the app. [source: Big Health FAQ; Otsuka; K173681]

Phase 3: Active course with integration and monitoring. Course lengths reported: Rejoyn six weeks; MamaLift Plus eight weeks; reSET and reSET-O 12 weeks; EndeavorRx an initial multi-week course with a daily play schedule set by the label or prescriber; NightWare nightly use; SleepioRx and DaylightRx course length not stated on the pages used [uncertain]. Goals: regular brief check-ins on use, content, symptoms and adverse effects; linking app skills to therapy work; acting on deterioration. Typical format: a few minutes at the start of each therapy session plus a mid-course review. [source: Otsuka; Biospace/Curio; pharmaphorum; K173681; Akili release; News-Medical/FDA]

Phase 4: End-of-course review (one session). Goals: compare symptom measures with baseline, consolidate skills into the client's own words and routines, decide with the prescriber whether anything continues. Move on when the client can name which skills they will keep using without the app.

Phase 5: After the course. Goals: relapse-prevention planning, booster therapy sessions, and a plan if the product is withdrawn or coverage ends.

3. Guiding principles

• Adjunct, never replacement. Every product here is labelled for use alongside care, medication or a programme; Rejoyn, EndeavorRx and reSET explicitly are not substitutes for medication. Meaning: the app sits inside a treatment plan someone owns. [source: Otsuka; Akili release; K173681]
• Stay inside the label. Indication and age are part of the authorisation (for example, 22 and older for DaylightRx, Rejoyn, NightWare and MamaLift Plus; 8 to 17 for EndeavorRx). Meaning: a 19-year-old with GAD or postpartum depression is outside the label; discuss alternatives rather than improvising. [source: as table]
• The app does not watch over the client. Otsuka states Rejoyn does not monitor symptoms or clinical status and cannot send or receive alerts to the prescriber. Meaning: assume no product will warn anyone of deterioration; the clinician's monitoring and crisis plan carry that load. [source: Otsuka]
• Medication decisions belong to the prescriber. Meaning: never suggest starting, stopping or changing an antidepressant, buprenorphine, ADHD or PTSD medicine because of app progress; route questions to the prescriber. [source: Otsuka states patients should continue current treatment as directed]
• Informed consent includes data. Meaning: before the order, discuss what the app records, who holds it and what the client can control [synthesis].
• Fit matters more than novelty. Meaning: language, literacy, device access, disability, cognitive state and preference decide whether self-guided content can work [synthesis, with Big Health's suitability criteria as source].
• Integrate, do not run parallel tracks. Meaning: name the app's skills in session and link them to the formulation [synthesis].
• Measure. Meaning: a validated symptom measure at baseline, mid-course and end, chosen by the clinician, rather than relying on in-app progress screens [synthesis].
• Children need a family frame. Meaning: for EndeavorRx, parents or carers consent and supervise use, the child gives assent, and the game sits within a wider ADHD programme. [synthesis; Akili release for "part of a therapeutic program"]
• Plan for product volatility. Meaning: keep a non-digital fallback ready (Pear bankruptcy, Akili sale). [source: mobihealthnews]
• Prescribe only within scope. Meaning: if your licence allows ordering (as Big Health states for several psychotherapy professions), you take on the prescriber's responsibilities for follow-up; if not, refer to a prescriber. [source: Big Health FAQ; synthesis]

4. Intervention inventory

Part A describes how each product is delivered, at the descriptive level the labelling and announcements give. Part B gives the psychotherapist's own interventions. Example language is illustrative throughout.

Part A. How each product is delivered

A1. SleepioRx (Big Health): digital CBT-I

• Purpose and when to use: chronic insomnia in adults 18 and older, as an adjunct to usual care. [source: Big Health FAQ]
• How it is delivered: the clinician orders through Big Health's ordering website using a unique access code, entering the patient's phone number; the patient receives a text with instructions to download and sign up; content is video and audio CBT-I lessons in a mobile app. [source: Big Health FAQ] For the CBT-I components themselves (sleep restriction, stimulus control and so on), their contraindications and how to support them, see guide 090.
• Example language (illustrative): "This app teaches the same insomnia programme we would do together, in short lessons. I'll keep checking how the sleep schedule is going, because that part is the hardest."
• Watch for: daytime sleepiness and safety when driving during the sleep-scheduling phase, and conditions that make CBT-I need medical oversight (see 090) [synthesis]; non-activation after the text arrives.

A2. DaylightRx (Big Health): digital CBT for generalised anxiety disorder

• Purpose and when to use: improve GAD symptoms in adults 22 and older, as an adjunct to usual care. [source: Big Health FAQ]
• How it is delivered: same ordering route as SleepioRx; video and audio CBT-based lessons in a mobile app. Detailed module content is [uncertain]. [source: Big Health FAQ]
• Example language (illustrative): "The app gives you daily practice in handling worry. Bring what you try to our sessions and we'll fit it to the situations that hook you most."
• Watch for: use of the app as reassurance-seeking or avoidance (endless lessons instead of facing feared situations) [synthesis]; worsening anxiety, depression or suicidal thinking.

A3. Rejoyn (Otsuka and Click Therapeutics): cognitive-emotional training for depression

• Purpose and when to use: reduce symptoms of major depressive disorder in adults 22 and older who are taking an antidepressant, as an adjunct to clinician-managed outpatient care. [source: Otsuka press release; mobihealthnews]
• How it is delivered: a six-week smartphone programme combining cognitive-emotional training exercises (the Emotional Faces Memory Task) with brief therapeutic lessons; prescription from a healthcare provider; downloaded from app stores; prescriber information at a separate HCP site. Otsuka lists no contraindications, states it is not a standalone therapy or a substitute for medication, that patients should continue current treatment as directed, that it does not monitor symptoms or clinical status and cannot send or receive alerts to the prescriber, and that if depression worsens or the patient has thoughts of harming themselves or others they should contact a healthcare professional, dial 911 or go to the nearest emergency room. [source: Otsuka press release]
• Example language (illustrative): "Rejoyn trains how your brain handles emotional faces and information, alongside your medication. It won't tell anyone if you're struggling, so I'll ask you about your mood every time we meet."
• Watch for: clients interpreting the app as a reason to stop their antidepressant (route to the prescriber); frustration with the training task; worsening mood or suicidal thinking during the course.

A4. reSET and reSET-O: CBT for substance use and opioid use disorder

• Purpose and when to use: reSET: adults 18 and older with a substance use disorder (not where opioids are the primary substance, not alcohol alone, and not on opioid replacement), enrolled in outpatient treatment under a clinician's supervision, as CBT adjunct to a contingency management system, over 12 weeks, to increase abstinence and retention. reSET-O: adults 18 and older with opioid use disorder under clinician supervision, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, to increase retention. FDA's special controls require labelling to state the device is not for standalone use and does not substitute for medication. [source: K173681 record, quoting the reSET De Novo and reSET-O indications]
• How it is delivered: a 12-week CBT course on a smartphone (per the indications for use, 90 days for reSET and 84 days for reSET-O), helping patients identify relapse triggers and ways to stop thinking about drug use; PursueCare relaunched both, initially within its own telehealth addiction programmes [source: pharmaphorum], and says it is setting up programmes with partner clinics, with a focus on value-based arrangements with health plans [source: PursueCare release, October 2024]. A general ordering route for clinicians outside these programmes is not described [uncertain].
• Example language (illustrative): "The app lessons are part of your programme, like the check-ins and the rewards for negative tests. Let's look at which trigger lesson matched last week's craving."
• Watch for: relapse, overdose risk after return to use (urgent liaison with the prescribing team), loss of access if the programme or product changes [synthesis].

A5. EndeavorRx: prescription video game for ADHD (ages 8 to 17)

• Purpose and when to use: improve attention function as measured by computer-based testing in children and adolescents aged 8 to 17 with primarily inattentive or combined-type ADHD who have a demonstrated attention issue; to be considered as part of a therapeutic programme, not used alone and not as a substitute for medication. [source: Akili release, December 2023] FDA's 2020 authorisation (ages 8 to 12) described it as one component of a broader therapeutic programme. [source: mobihealthnews, June 2020]
• How it is delivered: a prescription video game played on a device at home on a schedule set by the labelling or the child's prescriber over an initial course of several weeks (the specific schedule is in the labelling; not reproduced here). Reported adverse effects: in the original studies, no serious adverse events, with frustration, headache, dizziness, emotional reaction and aggression among the common adverse events; in the adolescent study, 2.5% had mild or moderate events (decreased frustration tolerance, one headache). [source: mobihealthnews 2020; Akili release 2023] Akili reduced promotion of EndeavorRx before its 2024 merger with Virtual Therapeutics. [source: mobihealthnews, May 2024] Current availability is [uncertain]; Akili also pursued a non-prescription version (EndeavorOTC), whose FDA status is [uncertain].
• Example language to the child (illustrative): "This is a game your doctor has prescribed to help your attention muscles. It's meant to be a bit hard, so if it gets annoying, tell your mum or dad, or me, and we'll work it out."
• Watch for: frustration, anger or meltdowns around play; headaches; the game replacing parent training, school supports or medication review; screen-time conflict in the family [synthesis based on reported adverse events].

A6. NightWare: smartwatch for PTSD-related nightmares

• Purpose and when to use: temporary reduction of sleep disturbance related to nightmares in adults 22 and older with nightmare disorder or PTSD-related nightmares; not a standalone PTSD therapy; to be used with prescribed PTSD medicines and other recommended therapies per consensus guidelines. [source: FDA announcement via News-Medical]
• How it is delivered: an Apple Watch and iPhone linked to a software app and server; sensors track movement and heart rate during sleep; an algorithm builds a personal sleep profile; when a likely nightmare is detected the watch vibrates to interrupt it without fully waking the person. Prescription only, for home use under provider supervision. The label-level guidance reported by FDA: wear it nightly at bedtime, not while reading or watching TV in bed, not too tightly; keep it away from a bed partner; stop and contact a provider for skin irritation; contact a provider for daytime sleepiness, vibrations waking the user without a nightmare, or nightmares that persist, worsen or recur. Not for people who act out during nightmares (for example sleepwalking or violence). In the pivotal sham-controlled trial, suicidality and sleepiness did not change in either group. [source: FDA announcement via News-Medical]
• Example language (illustrative): "The watch tries to nudge you out of a nightmare without waking you. It doesn't treat the trauma itself, so we'll keep doing the trauma work in here."
• Watch for: acting out during sleep (exclusion), new daytime sleepiness, avoidance of trauma-focused therapy because nights are easier [synthesis].

A7. MamaLift Plus (Curio): digital therapy for postpartum depression

• Purpose and when to use: mild to moderate postpartum depression in patients 22 and older, as an adjunct to clinician-managed outpatient care, under a healthcare provider's supervision; not a standalone treatment. Not appropriate for severe depression or anxiety, serious mental illness, psychosis or suicidal thoughts, or for patients under 22. [source: Curio release via BioSpace]
• How it is delivered: an eight-week smartphone or tablet programme, used daily in the trial, delivering CBT, behavioural activation, IPT and DBT content; prescription only; in a medical emergency patients are told to call 911 or go to the nearest emergency room. [source: Curio release via BioSpace]
• Example language (illustrative): "This programme has short daily pieces on mood, activity and relationships. If your mood drops sharply, or you have thoughts of harming yourself or the baby, that's not something for the app; call me, your doctor or 911 straight away."
• Watch for: escalation to severe depression, suicidal or infant-harm thoughts, or psychotic symptoms (postpartum psychosis is an emergency) [synthesis]; exhaustion making daily use impossible.

Part B. The psychotherapist's interventions

Unless a source is named, the steps in Part B are [synthesis]: standard collaborative-care practice applied to the labelling points in Part A.

B1. Fit and eligibility assessment

• Purpose and when to use: before suggesting any PDT, decide whether it suits this client now.
• Steps: (1) Confirm the working diagnosis matches a cleared indication, with a structured interview or validated measure. (2) Check age against the label (Section 1 table). (3) Screen for stated exclusions: severity, psychosis, serious mental illness and suicidal thoughts (MamaLift Plus); acting out during nightmares (NightWare); programme prerequisites (reSET: contingency management and outpatient enrolment; reSET-O: buprenorphine and contingency management; Rejoyn: current antidepressant). [source: Curio via BioSpace; FDA via News-Medical; K173681; Otsuka] (4) Check practical fit: language (Big Health requires conversational English), smartphone access, literacy, vision, hearing, motor and cognitive demands, privacy at home, and time. [source: Big Health FAQ] (5) Ask about preferences and past experience with self-help apps. (6) Record the decision and reasons.
• Example language (illustrative): "There's an FDA-cleared app for what you're dealing with. Before we decide, I need to check a few things: whether it's designed for your age and situation, and whether an app fits how you like to work."
• Watch for: pressure to use an app because therapy access is limited; clients who meet the label but whose risk level needs closer contact than an app plus occasional sessions.

B2. Psychoeducation and shared decision-making

• Purpose and when to use: once fit is plausible; to support an informed choice.
• Steps: (1) Explain in plain words what the product does, its method and course length. (2) State what it does not do: it is an adjunct; it does not monitor mood or alert anyone (stated for Rejoyn; assume the same for others unless labelling says otherwise). [source: Otsuka] (3) Lay out alternatives: therapist-delivered therapy, other evidence-based options, waiting, or nothing. (4) Discuss costs and coverage (Section 1). (5) Invite questions and concerns; offer time to decide. (6) Document the discussion and the client's choice.
• Example language (illustrative): "Think of it as structured homework with a medical clearance. It can add practice between our sessions, but it can't replace what we do together, and it won't notice if you're in trouble."
• Watch for: the client feeling handed off ("you're giving me an app instead of you"); unrealistic expectations of a cure.

B3. Data privacy and security conversation

• Purpose and when to use: as part of consent, before ordering or activation.
• Steps: (1) Read the product's current privacy policy and instructions for use yourself; each product's data practices are [uncertain] until you have read its policy. (2) Tell the client which categories of data the app is likely to hold (contact details from the order, symptom answers, usage, and for NightWare heart rate and movement data from the watch, per the FDA description). [source: FDA via News-Medical] (3) Explain who may see data (manufacturer, the ordering clinician's portal if one exists, insurer through billing), and that whether US health privacy law applies depends on the arrangement [uncertain]. (4) Advise basic device security: screen lock, not sharing logins, updating the app. (5) For clients with domestic abuse, custody disputes, immigration or employment concerns, weigh whether a phone record of mental-health treatment is safe. (6) For a child, discuss with the parent what data the game collects and who sees it.
• Example language (illustrative): "The app will store your answers and how often you use it. Here's what the company says it does with that. Is there anyone with access to your phone who you wouldn't want to see this?"
• Watch for: coercive control (a partner monitoring the phone); clients who later disengage because they feel watched.

B4. Ordering, onboarding and activation support

• Purpose and when to use: after the decision; whether you order (if within scope) or refer to a prescriber.
• Steps: (1) If your profession is listed as an eligible prescriber (Big Health lists clinical psychologists, clinical social workers, marriage and family therapists and mental health counsellors, within scope) and your licence and employer allow it, order through the manufacturer's route; otherwise refer to the client's physician or psychiatrist with a short letter stating the indication and your rationale. [source: Big Health FAQ] (2) Within a week, check the access text or code arrived and the app is installed. (3) Offer to go through the first screens together in session if the client wants. (4) Agree when and where they will use it. (5) Note the course end date in your record.
• Example language (illustrative): "Did the text with the download link come through? If you like, open it now and we'll do the setup together so nothing stalls."
• Watch for: codes not received, wrong phone number, incompatible device, the client quietly never starting.

B5. Integrating the app with therapy

• Purpose and when to use: throughout the course; to avoid two parallel treatments.
• Steps: (1) Ask which lesson or exercise they did since last session. (2) Link it to the formulation (for example, a reSET trigger lesson to last week's lapse; a MamaLift Plus activity module to the behavioural activation plan). (3) Rehearse the skill in session on a live example. (4) Adjust: if app content conflicts with your plan (for example, sleep scheduling while you are doing trauma work), discuss sequencing with the client and, for medical aspects, the prescriber. (5) Keep therapy content the app does not cover (trauma processing, relationships, grief) central.
• Example language (illustrative): "Which part of this week's lesson stuck with you? Let's try it on what happened with your mother on Sunday."
• Watch for: sessions turning into app troubleshooting; the client saying the app "says something different" from you.

B6. Adherence and ambivalence conversations

• Purpose and when to use: when use drops off or the client is unsure about continuing.
• Steps: (1) Ask neutrally about use, without blame. (2) Explore what gets in the way (time, boredom, difficulty, shame, privacy, mood). (3) Elicit the client's own reasons for and against continuing. (4) Problem-solve barriers they want help with. (5) Accept a decision to stop the app; it is the client's choice. For any linked medicine, never advise a change; refer questions to the prescriber.
• Example language (illustrative): "Sounds like the app has slipped this week. What's made it harder? And on balance, is it still worth it to you?"
• Watch for: stopping the app being read as "failing treatment"; disengagement that is actually a sign of worsening depression.

B7. Monitoring symptoms and adverse effects; passing them on

• Purpose and when to use: every session during the course.
• Steps: (1) Repeat a validated symptom measure at baseline, mid-course and end. (2) Ask about the adverse effects the sources list: frustration, headache, dizziness, emotional reaction and aggression for EndeavorRx; daytime sleepiness, vibrations waking the person without a nightmare, persistent or worsening nightmares and skin irritation for NightWare; worsening depression or thoughts of harm for Rejoyn. [source: mobihealthnews 2020; FDA via News-Medical; Otsuka] (3) With consent, inform the prescriber promptly of deterioration, adverse effects or clinical change. (4) Consider reporting a device problem to the manufacturer or FDA's adverse event system (MedWatch) [uncertain: confirm the reporting route in the product's labelling].
• Example language (illustrative): "Your score has gone up since we started. I'd like to let Dr. Lee know, so she can review your treatment. Is that okay?"
• Watch for: in-app progress that looks good while measured symptoms worsen.

B8. Safety planning and crisis pathways

• Purpose and when to use: before the course starts, and whenever risk rises.
• Steps: (1) Do a standard suicide and self-harm risk assessment at baseline. (2) Make clear the app is not a crisis service; Otsuka and Curio direct users in an emergency to 911 or the nearest emergency room, Otsuka also to a healthcare professional. [source: Otsuka; Curio via BioSpace] (3) Write a collaborative safety plan: warning signs, coping steps, people to contact, the 988 Suicide and Crisis Lifeline in the US [synthesis], your service's out-of-hours route, and lethal-means safety (safe storage or removal). (4) For postpartum clients, include thoughts of harming the baby and signs of postpartum psychosis in the plan, with urgent medical review. (5) For substance use, include overdose risk after relapse and how to reach the treatment programme. (6) Re-review the plan at each risk change.
• Example language (illustrative): "If things get really dark, the app can't help in that moment. Let's write down exactly who you'd call and what you'd do, so it's on your phone right next to the app."
• Watch for: clients disclosing risk in the app only (which no one reads); MamaLift Plus excludes suicidal thoughts, so new suicidal thinking means a review of whether the app is still appropriate, with the prescriber. [source: Curio via BioSpace]

B9. Children and adolescents (EndeavorRx): safeguarding, consent and assent

• Purpose and when to use: whenever EndeavorRx is considered for ages 8 to 17. Domain VIII guide 178 points here for this product.
• Steps: (1) Confirm ADHD subtype and a demonstrated attention issue, as the indication requires, and that the child is aged 8 to 17. [source: Akili release] (2) Get informed consent from the parent or legal guardian per local law, and age-appropriate assent from the child: explain in child language what the game is for, that it may feel hard, and that they can say if they don't want to do it. (3) Agree who supervises play and how screen time will be handled in the family. (4) Place the game within a broader ADHD plan (parent training, school supports, medical review); the label says it is not a substitute for medication. [source: Akili release] (5) Review frustration, aggression and headaches with the parent and child at each contact. [source: mobihealthnews 2020] (6) Use ordinary safeguarding procedures for any disclosure; a game course does not change duties to report. (7) For adolescents, discuss their own views and confidentiality limits directly.
• Example language to a parent (illustrative): "The game targets attention as measured on computer tests; it won't fix homework battles by itself. Let's plan the parent strategies and school support alongside it."
• Example language to a child (illustrative): "You get to choose too. If you try it and really hate it, you can tell me, and we'll talk about it with your parents."
• Watch for: the game becoming a battleground or reward chip; a child who withholds assent; signs of distress, family conflict or neglect, which are safeguarding matters regardless of the app.

B10. Collaborative care with the prescriber and programme

• Purpose and when to use: whenever someone else ordered the PDT or prescribes a linked medicine (antidepressant for Rejoyn; buprenorphine with reSET-O; PTSD medicines with NightWare).
• Steps: (1) Get written consent to share information. (2) Agree who monitors what and how often. (3) Send brief updates at start, mid-course, end and on any concern. (4) Leave all medication questions to the prescriber.
• Example language (illustrative, to a prescriber): "Ms. A started DaylightRx two weeks ago; GAD-7 is unchanged and she reports more worry about her job. I'm continuing weekly CBT; could you review at your next appointment?"
• Watch for: nobody owning follow-up when the ordering clinician and therapist assume the other is monitoring.

B11. Ending the course, consolidation and avoiding over-reliance

• Purpose and when to use: in the last weeks of the course and after.
• Steps: (1) Review measures against baseline. (2) Ask the client to name, in their own words, the two or three skills they will keep using. (3) Write a relapse-prevention plan that does not depend on the app. (4) Watch for repeated requests to re-prescribe as a way to avoid therapy work; discuss what the app is doing for them. (5) Plan for loss of the product (discontinuation, ownership change, coverage loss): note what equivalent therapist-delivered work you would offer.
• Example language (illustrative): "The app ends next week. If your phone vanished tomorrow, what would you still do from it?"
• Watch for: symptom return after the app ends; the client crediting all gains to the app and none to themselves.

5. Handling problems

The responses below are [synthesis] unless a source is named; the cited sources describe products, not the difficulties of using them in therapy.

• Never starts, or stops after a few days (non-adherence). Check activation within a week (B4). Name the barrier specifically (time slot, phone storage, boredom, shame). Offer to do a module together in session. If the client still does not want it, stop the app and continue therapist-delivered treatment; record the decision.
• Deterioration during the course. Treat as you would without the app: reassess risk, increase contact, inform the prescriber with consent, and review whether the app still fits. For MamaLift Plus, severe symptoms or suicidal thoughts fall outside its stated suitability. [source: Curio via BioSpace] Rejoyn tells users to contact a professional, dial 911 or go to an emergency room if depression worsens or thoughts of harm appear. [source: Otsuka]
• Crisis disclosed only inside the app, or found later. Remind clients at every review that nobody reads app entries in real time (Rejoyn explicitly cannot alert the prescriber). [source: Otsuka] Ask directly about anything they have typed into the app that they have not told you.
• Stuck: no change on measures by mid-course. Review fidelity (is the client doing the core exercises?), diagnosis and dose of therapy contact. Discuss with the client and prescriber whether to finish the course, add therapist-delivered sessions of the same method, or switch approach. Do not extend use beyond the label without the prescriber.
• Resistance or rupture ("you're fobbing me off with an app"). Acknowledge the feeling, make clear therapy continues, and offer the app as optional. Repair by asking what they need from you that an app can't give.
• Overwhelm. Postpartum clients, people in early recovery and children may find daily tasks too much. Agree a smaller, realistic routine with the prescriber's input where the label sets a schedule, or pause.
• Frustration and anger with EndeavorRx. Frustration was the most common side effect in pediatric trials, attributed to the game's difficulty. [source: Akili release] Coach parents to respond calmly, set a predictable play time, and report persistent aggression, headaches or dizziness to the prescriber. [source for symptoms: mobihealthnews 2020]
• Parent and child disagree. Hear the child's assent or refusal; a game that becomes a daily fight may harm more than help. Discuss alternatives within the ADHD plan.
• NightWare problems. Vibrations that wake the person without a nightmare, daytime sleepiness, persistent or worsening nightmares, or skin irritation are reasons to contact the prescriber, per FDA. Acting out during nightmares means the device is not suitable. [source: FDA via News-Medical] If nights improve and the client wants to drop trauma-focused therapy, explore avoidance gently: the device is not a PTSD treatment. [source: FDA via News-Medical]
• Relapse during reSET or reSET-O. Treat a lapse as information for CBT work, not failure; liaise urgently with the programme about overdose risk and medication review; never comment on buprenorphine decisions.
• Product withdrawn, company sold or support ends (modality-specific). As happened with Pear Therapeutics in 2023 and Akili in 2024. [source: mobihealthnews] Tell clients early that this can happen; keep copies of what they have learned (their own notes, not screenshots of copyrighted content); offer equivalent therapist-delivered sessions; inform the prescriber.
• Coverage denied or high cost. Check plan coverage before ordering; Medicare DMHT billing requires the practitioner to purchase and furnish the licence, and coinsurance applies. [source: Big Health FAQ] Do not let cost pressure drive a client into an unsuitable product; offer non-digital options.
• Client outside the label (for example under 22 for DaylightRx, Rejoyn, NightWare or MamaLift Plus). Explain the label, offer evidence-based therapist-delivered alternatives, and leave any off-label decision to the prescriber.
• Client asks for the app instead of therapy, or uses a consumer wellness app or general AI chatbot instead. Explain the difference between an FDA-authorised product used under supervision and unregulated apps; keep the therapy relationship as the anchor; ask what the tool gives them and what risks they notice.
• Privacy fears or coercive control. Revisit B3; consider not using a phone-based product, or using it only with safety planning for technology abuse.
• Language, disability and access barriers. Big Health requires conversational English. [source: Big Health FAQ] For clients who cannot use the app well, therapist-delivered versions of the same method are the default.

Sources

• Big Health: FDA-cleared treatments (FAQ)
• Big Health: news (SleepioRx and DaylightRx clearances)
• Otsuka: Rejoyn FDA authorised (press release, 1 April 2024)
• mobihealthnews: Otsuka, Click Therapeutics get FDA clearance for prescription digital therapeutic (April 2024)
• mobihealthnews: Pear Therapeutics assets sold for $6M at auction after bankruptcy (May 2023)
• pharmaphorum: PursueCare brings Pear addiction DTx apps back to life (October 2024)
• FDA 510(k) record K173681, reSET-O, via Innolitics database
• FDA 510(k) record K231209, Rejoyn, via Innolitics database
• PursueCare/BusinessWire: PursueCare introduces RESET and RESET-O (October 2024)
• MedTech Dive: Akili to sell to Virtual Therapeutics for $34M (30 May 2024)
• Akili/BusinessWire: EndeavorRx label expansion to ages 13 to 17 (18 December 2023)
• mobihealthnews: EndeavorRx receives FDA De Novo clearance (June 2020)
• mobihealthnews: Akili to merge with Virtual Therapeutics in $34M deal (May 2024)
• News-Medical: FDA authorizes marketing of new device intended to provide temporary relief from sleep disturbances (NightWare, November 2020)
• BioSpace: Curio Digital Therapeutics announces FDA clearance of MamaLift Plus (April 2024)
• Sidley Austin: CMS finalizes key Medicare reimbursement policies for telehealth, chronic disease and digital health (November 2025)

[uncertain]: each product's full instructions for use and privacy policy; current market availability in October 2026; regulatory status outside the US; detailed CMS DMHT billing conditions; adverse-event reporting route. Check these directly with the manufacturer, FDA and CMS before use.