1. Introduction
Version followed: Alicia E. Meuret's manualised capnometry-assisted breathing therapy for panic disorder as published by Meuret, Wilhelm and Roth (Stanford/Hamburg work, described in the 2001 Behavior Modification paper and Meuret's 2003 Hamburg dissertation; tested in the 2008 Journal of Psychiatric Research RCT), later called capnometry-assisted respiratory training (CART) by Meuret's Southern Methodist University group; plus its commercial device form, Freespira (Palo Alto Health Sciences; first cleared as the Canary Breathing System), delivered as a 28-day prescription home programme with coaching, as its FDA summaries, trial reports and product profile describe it. Where the two differ, both are given and labelled.
CART is a short respiratory biofeedback treatment. A portable capnometer samples exhaled air through a nasal cannula and shows the person, breath by breath, their respiratory rate and end-tidal CO2 (the CO2 level at the end of each out-breath). The core idea: many people with panic disorder breathe in ways that lower CO2 (hyperventilation, irregular or chest breathing), and low CO2 produces or amplifies the bodily sensations that feed panic. With live feedback and paced tones, the person learns to slow and steady their breathing and to bring end-tidal CO2 up toward the normal range, practises this daily at home, and then uses it in situations that trigger symptoms. [source: Meuret 2003 dissertation; Meuret, Wilhelm & Roth 2004; Meuret et al. 2008]
Two features set it apart from ordinary breathing retraining. First, breathing is measured, not assumed: the therapist and client look at the client's actual CO2 and rate data in every session. Second, CART's stated aim is to raise CO2, which Meuret's group describe as the opposite of what traditional breathing training (slow, deep breaths) often does, since deep breathing can itself lower CO2. [source: Hasratian 2023 SMU dissertation page; Meuret et al. 2008 abstract] The method was first developed for panic disorder; Meuret's group has also applied it to asthma (a 2012 case illustration of hypoventilation training) and in a transdiagnostic negative-affect sample, and the Freespira device is cleared for panic disorder and PTSD symptoms. [source: Jeter et al. 2012 abstract; Hasratian 2023; FDA K180173 summary]
Who delivers it: in Meuret's trials, a psychologist delivered the sessions from a manual, with a psychiatrist conducting a separate interview. Freespira is set up and followed by a clinician or a Freespira coach. A psychotherapist can deliver CART-style respiratory biofeedback if trained in it and working with suitable equipment and medical screening; with Freespira, the psychotherapist more often works alongside the prescribing or authorising clinician and the company's coaches. [source: Meuret 2003; DTx Alliance profile] No cited source names a required credential for CART; general biofeedback certification (for example through the Biofeedback Certification International Alliance, BCIA) exists; it covers biofeedback generally (including respiration), not CART specifically [source: BCIA, BF Entry Level].
2. Framework
Version A: Meuret's original therapist-delivered protocol (panic disorder)
[source: Meuret 2003 dissertation, reprinting Meuret, Wilhelm & Roth 2001; Meuret et al. 2008]
- Format: five individual sessions over about four weeks, each about 80 minutes, from a written manual; the client receives a portable capnometer and a therapy manual for home use.
- Pre-treatment assessment: phone screen, structured and unstructured diagnostic interviews, and medical screening. In the research version, a 24-hour ambulatory recording of breathing and autonomic measures was made, with brief standardised hyperventilation and walking tests, and these recordings were used in therapy.
- Session 1 (rationale and skill acquisition): review of the client's own recordings; explanation of a hyperventilation-based model linking fast, deep or irregular breathing to symptoms; teaching slow diaphragmatic breathing lying and sitting; paced breathing to audio tones while watching the capnometer; trying out different breathing patterns to see their effect on the readings; home-practice instructions.
- Sessions 2–4 (progression and transfer): downloading and graphing the week's home-practice data with the client; stepping the paced breathing rate down each week; tailoring techniques to the person; applying the skills in difficult real-life situations.
- Session 5 (maintenance): reviewing the principles, consolidating gains and making coping plans for future stressors.
- Between sessions: home exercises twice daily, spaced hours apart, each with three phases (quiet rest; paced breathing with feedback; unpaced breathing holding the same pattern), plus logs and diaries.
- Follow-up: reassessment after treatment and at later follow-ups (around two months in the dissertation; two and twelve months in the 2008 RCT).
- Moving between phases: the published criterion is time-based (weekly steps) adjusted to the individual's data; the client is asked to raise their readings progressively. Exact pacing rates and CO2 targets belong to the manual and device and are not given here.
Version B: Freespira (device-based home programme, panic disorder and PTSD)
[source: Ostacher et al. 2021; FDA K131586 and K180173 summaries; DTx Alliance profile; Freespira press release, May 2025; FDA K233337 summary]
- Referral and authorisation: the device is prescription-use under FDA labelling. The DTx Alliance profile states that authorisation from a licensed healthcare provider is required, not necessarily a physician's prescription, and that patients can self-refer through the company or be referred by a provider.
- Assessment: in the PTSD trial, a Masters-level clinician took medical and psychiatric history, medications and substance use, confirmed the diagnosis with a structured interview, and an investigator confirmed eligibility, including screening for lung problems.
- Training visit: the client is trained on the sensor, cannula and tablet and completes a first session with the trainer.
- Home phase (28 days): two short sessions a day. Each starts with a brief resting measurement, then gives real-time feedback while the client breathes in time with a rising and falling tone and adjusts breath depth to reach a CO2 target. The target breathing rate is stepped down week by week. Data upload automatically for clinician review.
- Weekly contact: four weekly coaching contacts (video or phone) reviewing uploaded data, adherence and progress; in the trial, staff did not deliver trauma-focused therapy.
- Ending: treatment ends after four weeks; the referring provider receives a post-treatment report; trials reassessed at two and six months (PTSD) or up to twelve months (panic).
Version C: youth adaptation (research protocol)
A ClinicalTrials.gov protocol for children and teens (NCT02998502, 2018) added parental consent with child assent, motivational interviewing, a reward plan (tokens for younger children, personal reasons for adolescents), parental help with home sessions, a daily panic diary, brief weekly phone or video check-ins, and a week-4 data review visit. [source: NCT02998502 protocol]
Regulatory status (as of October 2026, per the cited sources)
- United States: Class II biofeedback device (21 CFR 882.5050), prescription use. Cleared 10 December 2013 as the Canary Breathing System (K131586) for use as a relaxation treatment for stress reduction and as an adjunctive treatment of panic disorder symptoms, under a healthcare professional's direction alongside other drug or non-drug treatments. Cleared 23 August 2018 as Freespira (K180173), adding PTSD symptoms to the adjunctive indication. [source: FDA 510(k) summaries via Innolitics] Cleared 24 April 2025 as the Freespira Breathing System (K233337; product code SEN, with CCK for the CO2 analyser), same design and technology as K180173. The adult indication is unchanged (adjunctive treatment of panic disorder and/or PTSD symptoms). For ages 13–17 the indication is narrower: a relaxation treatment for stress reduction and an adjunctive treatment of patient-reported symptoms of stress and anxiety, prescription only, under a healthcare professional's direction alongside other treatment; it is not a panic disorder or PTSD indication for adolescents. The supporting data were a small feasibility study, a pilot waitlist trial in ages 9–17 that missed its primary hypothesis, and post-hoc real-world data; reported events in adolescents matched those in adults, with shortness of breath in early sessions the most common. [source: FDA 510(k) database and K233337 summary] The company's May 2025 press release calls this its third FDA clearance. [source: Freespira press release] No separate 2020 PTSD clearance appears among the clearances cited here. [uncertain]
- Labelled cautions (per the DTx Alliance profile, last modified April 2024): not indicated for people under 13, during pregnancy, or for people with COPD or emphysema; adjunctive treatment only.
- Outside the US: no CE/UKCA marking, NICE assessment or other non-US regulatory status was found in the cited sources. [uncertain]
Evidence status (attributed)
- Meuret et al. (2008) randomised 37 people with panic disorder to the breathing therapy or a delayed-treatment control and reported improvements in panic severity, avoidance, anxiety sensitivity, disability and respiratory measures, maintained at 12 months; the authors call the benefit preliminary and say replication is needed.
- Ostacher et al. (2021), a single-arm trial of Freespira for PTSD, reported adherence of about three quarters of sessions and two possibly device-related adverse events (chest pain; night-time breathlessness), both resolving without intervention.
- The DTx Alliance profile and company press release cite further studies (a multisite benchmarking trial by Tolin and colleagues, an employer programme, a health-economic study) and company-reported remission and cost figures; these are the company's and profile's claims. [uncertain: company-reported]
- No NICE guidance position on CART or Freespira was found in the cited sources. [uncertain]
3. Guiding principles
[source: Meuret 2003; Meuret, Wilhelm & Roth 2004; Meuret et al. 2008; Hasratian 2023; Freespira labelling. Principles marked [synthesis] are this guide's own.]
- Measure breathing, don't guess it. Base decisions on the client's recorded CO2 and rate, not on how the breathing looks or feels.
- Raise CO2, don't deepen breaths. Steer away from the common advice to take big slow breaths; the aim is slower, steadier, shallower-enough breathing that brings CO2 toward normal.
- Four targets. Meuret, Wilhelm and Roth name overall ventilation, irregularity of rate, irregularity of depth, and chest breathing as the things to change; check each in the data.
- The client's own data are the psychoeducation. Explain the model using their recordings and live readings, so the link between breathing and symptoms is seen, not just told.
- Home practice is the treatment. Sessions set up, review and adjust; the change happens in twice-daily practice, so adherence is the first thing reviewed each week.
- Graded, individual progression. Step pacing down weekly but adjust to what the person's data show they can manage.
- Transfer is planned, not hoped for. From the middle sessions on, plan use of the skill in real situations that trigger symptoms.
- End with a maintenance plan. The last session consolidates principles and plans for future stressors.
- Medical screening comes first. Lung, heart and seizure conditions, pregnancy and other exclusions are checked before training, and new physical symptoms go back to a doctor.
- Adjunctive, not stand-alone (Freespira). Labelling places the device alongside other drug or non-drug treatment under a healthcare professional's direction; keep the wider treatment plan in view.
- Transient sensations are expected; persistent or alarming ones are not. Mild light-headedness or headache early in training may ease with practice; chest pain or breathlessness is reported to the medical team. [source: NCT02998502; Ostacher et al. 2021]
- Medication is the prescriber's business. Trials required stable medication; the therapist records changes and never advises them. [source: Meuret 2003; NCT02998502]
- Watch that the skill does not become a safety behaviour. If a client uses breathing to avoid or escape feared sensations, discuss it, especially when exposure therapy is also under way. [synthesis]
4. Intervention inventory
Part A describes the treatment components as the developers and the Freespira materials publish them. Pacing rates, CO2 targets, screening cut-offs and device settings are set by the manual or device and are deliberately not given. Part B covers the psychotherapist's own work around the treatment. Example wording is illustrative throughout.
Part A. The treatment components
A1. Pre-treatment assessment and medical screening
- Purpose: confirm the diagnosis, get a baseline, and rule out medical reasons not to do breathing training.
- Steps: (1) Diagnostic interview for panic disorder (with or without agoraphobia) or PTSD, using a structured interview where possible (the PTSD trial used the CAPS-5). (2) Medical and psychiatric history, current medicines, substance use. (3) Check exclusions the trials used: lung disease (including COPD and emphysema), symptomatic heart or cardiovascular disease, epilepsy or recent seizures, pregnancy, psychotic or uncontrolled bipolar disorder, serious suicidal intent, substance use needing acute medical care, and (in youth) active asthma. Freespira screening also used a COPD questionnaire and a high resting CO2 reading as signs of impaired lung function. (4) Baseline questionnaires on panic severity, avoidance, anxiety sensitivity, mood and functioning. (5) In the original research protocol, a 24-hour ambulatory breathing recording with brief hyperventilation and walking tests. [source: Meuret 2003; Ostacher et al. 2021; NCT02998502]
- Example language (illustrative): "Before we start breathing training I need to check a few things about your lungs, heart and general health, and I'll want your doctor to confirm it's suitable for you."
- Watch for: any respiratory, cardiac or seizure history, pregnancy, or unexplained chest symptoms: route to a physician before training. Asthma was not a blanket exclusion in Meuret's adult asthma work, but it was in the youth study, so it needs medical sign-off. [source: Jeter et al. 2012; NCT02998502]
A2. Rationale and psychoeducation from the client's own data
- Purpose: give a credible model that links breathing, CO2 and symptoms, and motivate practice.
- Steps: (1) Show the client their own baseline recording or live readings. (2) Explain, in plain terms, how fast, deep or irregular breathing lowers CO2 and how low CO2 can produce dizziness, tingling, breathlessness and other panic sensations. (3) Link this to the client's own panic attacks or trauma-related arousal. (4) Explain that training aims to bring CO2 back up toward normal by changing how they breathe, and why this differs from "take a deep breath." (5) Introduce the home manual or app. [source: Meuret 2003; NCT02998502; Hasratian 2023]
- Example language (illustrative): "See how your CO2 dropped while you were talking about the attack? That drop can cause exactly the tingling and light-headedness you described. We're going to train your breathing so it stays in a healthier range."
- Watch for: the client reading the model as "I'm in danger if my CO2 drops" (frame symptoms as uncomfortable, not harmful) [synthesis]; and in PTSD, the Freespira materials link breathing and CO2 sensitivity to arousal, but the psychoeducation content is not detailed in the trial report. [uncertain]
- How you know it's working: the client can explain the link in their own words and connects it to a recent episode.
A3. Slow diaphragmatic breathing instruction
- Purpose: reduce chest breathing and give a steadier base pattern.
- Steps: (1) Practise lying down first, then sitting. (2) Hand placement or other cues so the client feels the abdomen move more than the chest [synthesis on the cue]. (3) Keep breaths modest in depth, not big. (4) Check effect on the capnometer. [source: Meuret 2003]
- Example language (illustrative): "Let the breath move your belly rather than your chest, and keep it small and easy. Let's see what the screen shows."
- Watch for: clients who 'try hard' and breathe more deeply, which can lower CO2; the readings show this immediately.
A4. Paced breathing to audio tones
- Purpose: slow and regularise breathing rate.
- Steps: (1) The device or recording gives rising and falling tones for in- and out-breaths. (2) The client breathes in time while watching rate and CO2. (3) The therapist coaches adjustments to depth so CO2 rises rather than falls. (4) The paced rate is lowered in steps over the weeks (values per manual or device). [source: Meuret 2003; Ostacher et al. 2021; K131586 summary]
- Example language (illustrative): "Follow the tone up as you breathe in and down as you breathe out. If the CO2 number dips, make the next breaths a little smaller."
- Watch for: air hunger when slowing down (often eases with small adjustments); rising anxiety; clients matching rate but over-breathing in depth.
A5. Feedback-guided breathing experiments
- Purpose: let the client discover directly how different breathing patterns change CO2 and sensations.
- Steps: (1) While connected, the client briefly tries different patterns (for example faster, deeper, more irregular, then slower and steadier). (2) Together you note what happens to the readings and to sensations. (3) Return to the trained pattern and watch recovery. In the original protocol, brief standardised hyperventilation was part of assessment; any voluntary over-breathing in session should stay brief and supervised and follow the medical screening. [source: Meuret 2003; safety framing synthesis]
- Example language (illustrative): "Let's do a short experiment: breathe faster for a moment and notice what happens on the screen and in your body. Then we'll bring it back."
- Watch for: panic in session (slow down, reassure, return to paced breathing); any chest pain (stop and seek medical advice).
- How you know it's working: the client can predict the effect of a pattern before seeing the number.
A6. Twice-daily home exercise
- Purpose: build the skill through repeated practice.
- Steps (original version): two short exercises a day, hours apart, each with three phases: (1) quiet rest with eyes closed (baseline), (2) paced breathing with periodic checks of the readings, (3) an unpaced phase holding the same pattern with feedback only. The client aims to raise their readings gradually over the weeks. Freespira version: a brief resting measurement, then breathing with the tone and adjusting depth to reach a CO2 target, with data uploaded automatically. [source: Meuret 2003; Ostacher et al. 2021]
- Example language (illustrative): "Pick two fixed times that work, like after breakfast and early evening, so it becomes routine."
- Watch for: missed sessions (the device records them), practising only when calm or only when anxious, and early headaches or light-headedness, which the youth protocol says typically ease.
A7. Self-monitoring: logs and diaries
- Purpose: connect breathing practice to symptoms and track panic.
- Steps: (1) Breathing-training log: symptoms and emotions before and after each exercise. (2) Daily mood record. (3) Panic attack diary (Freespira youth version: daily diary of attacks and how easy the session was). (4) Bring or upload for review. [source: Meuret 2003; NCT02998502]
- Watch for: blank or retrospectively filled logs; look for patterns between low-CO2 days and anxious days.
- Example language (illustrative): "Let's look at your log together. On the days your readings were lower, what was going on, and how anxious were you?" [synthesis]
A8. Weekly data review and progression
- Purpose: reinforce practice, solve problems and step the training forward.
- Steps: (1) Download or open the week's data and show it graphically. (2) Review adherence first. (3) Review trends in rate and CO2 across and within sessions, alongside diaries. (4) Decide the next step: lower the pacing as planned, or hold if the data show the client is struggling. (5) Adjust technique to the individual. (6) In Freespira, this happens in weekly video or phone coaching; in the youth study, missed sessions triggered parent contact and problem-solving. [source: Meuret 2003; Ostacher et al. 2021; NCT02998502]
- Example language (illustrative): "You did eleven of fourteen sessions, and look how your CO2 climbed by the end of each one. Let's see what got in the way on the days you missed."
- How you know it's working: resting and session CO2 rising toward the normal range, steadier rate, fewer or milder attacks in the diary.
A9. Using the skill in triggering situations (generalisation)
- Purpose: transfer from the quiet practice setting to real life.
- Steps: (1) From sessions 2–4, list situations where symptoms arise. (2) Plan how the client will notice early over-breathing and shift to the trained pattern. (3) Practise briefly in session, then try it in the situation, and review what happened. [source: Meuret 2003] In the PTSD trial, the authors proposed that the skill could transfer to triggering situations but did not test this. [source: Ostacher et al. 2021]
- Example language (illustrative): "When you feel that first breathless rush in the supermarket, what's the smallest change to your breathing you could make right there?"
- Watch for: using breathing to escape a situation rather than stay in it [synthesis].
A10. Maintenance and relapse planning (final session)
- Purpose: keep gains after the device goes back.
- Steps: (1) Review the principles in the client's words. (2) Identify likely future stressors. (3) Write a coping plan: early signs, breathing response, other supports. (4) Agree on continued practice without the device and on when to seek help. [source: Meuret 2003; continued practice without the device is synthesis]
- Example language (illustrative): "Without the screen, what will tell you your breathing is drifting, and what will you do?"
- Watch for: a plan that depends on the device, or a client who expects never to feel anxious again; build the plan around skills and normal ups and downs. [synthesis]
A11. Post-treatment and follow-up assessment
- Purpose: check outcome and maintenance.
- Steps: repeat the baseline measures at the end of treatment and at follow-up (two and twelve months in the 2008 RCT; two and six months in the PTSD trial); Freespira sends the referring provider a post-treatment report. [source: Meuret et al. 2008; Ostacher et al. 2021; DTx Alliance profile]
- Watch for: return of symptoms at follow-up: offer a booster review or further treatment [synthesis].
- Example language (illustrative): "Now the programme has finished, let's repeat the questionnaires from the start so we can see together what changed." [synthesis]
Part B. The psychotherapist's role in panic and PTSD care
The sources describe the treatment, not the role of a psychotherapist working alongside it; Part B is this guide's own synthesis built on those sources. [synthesis]
B1. Recognising candidates and arranging referral
- Purpose: offer the option to clients likely to benefit, through the right route.
- Steps: (1) Consider it for adults with panic disorder or PTSD who report breathlessness, dizziness or other breathing-linked symptoms, prefer a non-drug option, or have trouble reaching weekly therapy. For adolescents 13–17, the 2025 clearance covers patient-reported stress and anxiety symptoms as an adjunct, not panic disorder or PTSD as such [source: FDA K233337 summary]. (2) Screen for red flags (lung or heart disease, seizures, pregnancy, active asthma in youth, current suicidality, psychosis, unstable bipolar disorder, substance use needing medical care). (3) Arrange medical sign-off from the client's physician where any physical condition exists. (4) Refer via the authorising provider or the company route; with consent, agree who receives the post-treatment report. [source for criteria: Ostacher et al. 2021; Meuret 2003; DTx Alliance profile; NCT02998502]
- Example language (illustrative): "There's a four-week home breathing programme with a CO2 sensor that's cleared for panic symptoms. It isn't right for everyone medically, so your doctor would need to check it with you first."
- Watch for: new or unexplained physical symptoms that have never been medically assessed: arrange a medical review first, whether or not CART goes ahead.
B2. Supporting informed consent and shared decision-making
- Purpose: help the client choose with accurate expectations.
- Steps: (1) Explain what the treatment involves day to day (twice-daily home sessions, weekly contact, wearing a nasal cannula). (2) State its status accurately: an FDA-cleared prescription device for adjunctive treatment, with promising but limited trial evidence, much of it uncontrolled or industry-linked. (3) Mention reported side effects: early light-headedness, dizziness or headache; chest pain and night-time breathlessness reported in the PTSD trial; cold symptoms in the 2018 summary. (4) Cover data: session data upload to a cloud server for clinician review; suggest the client asks the provider about privacy terms. (5) Use ask-tell-ask to check understanding, as the youth protocol did. [source: K180173 summary; Ostacher et al. 2021; NCT02998502]
- Example language (illustrative): "What have you understood about how much time this takes each day, and what would make that hard?"
- Watch for: expectations of a cure, or consent given mainly to please the referrer; check understanding again before the device starts. [synthesis]
B3. Adherence and ambivalence conversations
- Purpose: support the twice-daily practice the outcome depends on.
- Steps: (1) Ask about practice at each therapy session. (2) Use motivational interviewing to explore reasons for and against practising; the youth protocol used MI and reward plans. (3) Problem-solve practical barriers (timing, privacy, device problems: route those to the coach or provider). (4) Respect a decision to stop; never pressure, and tell the treating provider. [source for MI and rewards: NCT02998502]
- Example language (illustrative): "Part of you wants this to work and part of you dreads the sensor. Can we hear from both?"
- Watch for: practice falling off after the first week, shame about missed sessions, or arguing for practice in ways that increase resistance. [synthesis]
B4. Monitoring and passing on side effects and warning signs
- Purpose: keep the medical team informed and the client safe.
- Steps: (1) Ask about headaches, dizziness, chest pain, breathlessness (including at night) and any new physical symptoms. (2) Mild early symptoms that ease: note and pass to the coach or provider. (3) Chest pain, breathlessness that does not settle, fainting or seizure: stop the session and get urgent medical help, then inform the provider. (4) Record medication changes made by the prescriber; never suggest starting, stopping or changing medicines. [source for symptoms: NCT02998502; Ostacher et al. 2021; K180173 summary; urgent-care routing synthesis]
- Example language (illustrative): "Chest pain isn't something to push through. Please stop and get it checked today, and I'll let the team know."
- Watch for: symptoms the client dismisses as 'just anxiety'; pass on anything new or persistent to the provider rather than interpreting it yourself. [synthesis]
B5. Crisis and safety planning
- Purpose: handle suicidality and crises, which device programmes are not designed to manage.
- Steps: (1) Assess suicide risk at baseline and during treatment using your usual risk-assessment practice; trials excluded serious suicidality and referred emerging depression or suicidal thoughts for evaluation. (2) Keep a written safety plan that names who to call and how the coach or provider will be told. (3) Make sure the client knows the coach contact is not a crisis service. [source: Ostacher et al. 2021; NCT02998502; synthesis for steps 2–3]
- Example language (illustrative): "If things get much worse, especially thoughts of ending your life, the breathing programme isn't the place to handle that. Let's agree now who you'd contact and how." [synthesis]
- Watch for: new or rising hopelessness or suicidal thoughts during the programme; review the safety plan and inform the referring clinician. [synthesis]
B6. Integrating psychotherapy before, during and after
- Purpose: fit the breathing programme into a coherent treatment plan.
- Steps: (1) Before: formulate how breathing symptoms fit the client's panic or PTSD cycle. (2) During: labelling places Freespira alongside other treatment, but the PTSD trial excluded concurrent evidence-based trauma therapy (CPT, EMDR, PE, CBT, VR therapy), so decide with the team whether to run them together or in sequence. (3) For panic, CART can come before or alongside CBT; frame breathing as a way to correct a physiological pattern, then go on to interoceptive and situational exposure without relying on breathing to escape sensations. (4) After: use the gains in later trauma-focused or exposure work. [source for labelling and exclusions: K180173; Ostacher et al. 2021; sequencing and exposure framing synthesis]
- Example language (illustrative): "The breathing training settles the physical side. Next we'll practise letting those sensations come without needing to control them."
- Watch for: breathing skills turning into a safety behaviour during exposure work; discuss it openly and adjust together. [synthesis]
B7. Support after the device programme ends
- Purpose: maintain gains and catch relapse.
- Steps: (1) Review the post-treatment report with the client (with consent). (2) Revisit the maintenance plan from A10. (3) Schedule follow-up checks on panic or PTSD symptoms. (4) If symptoms return, discuss options (booster with the provider, CBT or trauma-focused therapy, medical review). [synthesis; report from DTx Alliance profile]
- Example language (illustrative): "The programme report shows what changed. Let's check in again in a few weeks to see how it's holding up." [synthesis]
- Watch for: panic or avoidance returning once the device has gone; offer a review and further treatment rather than waiting. [synthesis]
5. Handling problems
Sources address adherence monitoring, early transient symptoms, suicidality referral and removal for non-completion; the rest is this guide's synthesis and is marked.
- Missed home sessions (non-adherence). The device records every session, so raise it in a curious, not critical, way. Problem-solve timing, privacy and device issues; in youth, involve the parent and a reward plan; Freespira coaches handle device problems. Trials removed participants who did not complete most sessions, because the effect cannot be judged without practice. [source: Meuret 2003; NCT02998502] Ask whether avoidance of the sensations is behind the missed sessions. [synthesis]
- Dizziness, headache or light-headedness early on. The youth protocol says these typically lessen over later sessions. Check that the client is not over-breathing in depth while matching the tone, and pass persistent symptoms to the provider. [source: NCT02998502; depth check synthesis]
- Chest pain, breathlessness or other alarming physical symptoms. Reported as possibly device-related in the PTSD trial (both resolved). Stop, seek medical assessment, inform the provider; do not reassure that it is "just anxiety" without a medical opinion. [source: Ostacher et al. 2021; response synthesis]
- Panic during a session or when slowing breathing (air hunger). Normalise the sensation, slow down, make breaths a little smaller rather than bigger, and return to the tone; review afterwards what the client feared would happen. [synthesis]
- CO2 not rising despite practice (stuck). Review the data with the client and the coach: look for deep breaths, sighs, talking during sessions, or irregular rhythm (the four targets). Hold the current step rather than progressing. If there is still no change, ask for medical review, since persistently abnormal readings can reflect a lung or metabolic problem; Freespira screening treated a high resting CO2 as a sign of impaired lung function. [source: Meuret, Wilhelm & Roth 2004; Ostacher et al. 2021; rest synthesis]
- Readings improve but panic or PTSD symptoms do not. Breathing change and symptom change can come apart. Revisit the formulation: catastrophic misinterpretation, avoidance, or trauma memories may need CBT, exposure or trauma-focused therapy. [synthesis]
- Breathing used as a safety behaviour. If the client feels unable to cope without controlling their breathing, or uses it to escape situations, discuss this and plan exposure in which sensations are allowed to occur. [synthesis]
- Over-focus on numbers or health anxiety. Some clients check readings anxiously or fear low CO2. Shift the emphasis to the trend and to what they can do, and fade reliance on the screen toward the end. [synthesis]
- Trauma cues from the equipment (PTSD). Nasal cannulas or medical settings can resemble past medical trauma or restraint for some clients. Ask beforehand, allow the client to handle the equipment first, and agree a stop signal. [synthesis]
- Rupture: "you're just handing me a gadget." Acknowledge the concern, explain how the programme fits the wider plan, and keep therapy sessions for the client's wider concerns. [synthesis]
- Overwhelm or worsening mood, suicidal thoughts. Follow your standard risk assessment and safety plan, and tell the provider; the trials referred emerging depression or suicidality for evaluation. [source: NCT02998502; Ostacher et al. 2021]
- Medication questions. If the client asks whether to stop medication now that they are breathing better, route to the prescriber; studies required medication to stay stable. [source: Meuret 2003; NCT02998502]
- Pregnancy, new lung or heart diagnosis during treatment. Labelled cautions (pregnancy, COPD, emphysema) and trial exclusions mean the provider must be told before continuing. [source: DTx Alliance profile; Ostacher et al. 2021]
- Relapse after the programme ends. Use the maintenance plan; offer booster review and therapy; return to the provider about repeating or extending treatment. [synthesis]
Sources
Online sources:
- Meuret, A. E. (2003). Effects of Capnometry-Assisted Breathing Therapy on Symptoms and Respiration in Panic Disorder (dissertation, University of Hamburg; reprints Meuret, Wilhelm & Roth 2001, Behavior Modification)
- Meuret, Wilhelm, Ritz & Roth (2008). Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder. Journal of Psychiatric Research 42(7), 560–568 (repository record)
- Meuret, Wilhelm & Roth (2004). Respiratory feedback for treating panic disorder. Journal of Clinical Psychology 60, 197–207 (repository record)
- Ostacher, Fischer, Bowen et al. (2021). Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. Applied Psychophysiology and Biofeedback 46, 367–376
- Jeter, Kim, Simon et al. (2012). Hypoventilation Training for Asthma: A Case Illustration. Applied Psychophysiology and Biofeedback 37, 63–72
- Hasratian, A. (2023). Examining the Mediating Role of CO2 in Symptom Change During CART Using a Transdiagnostic Sample (SMU dissertation record)
- FDA 510(k) K131586, Canary Breathing System, 10 Dec 2013 (Innolitics record)
- FDA 510(k) K180173, Freespira, 23 Aug 2018 (Innolitics record)
- FDA 510(k) database: K233337, Freespira Breathing System, decision 24 Apr 2025
- FDA 510(k) summary and indications for use, K233337 (PDF)
- Freespira Receives FDA Clearance for Adolescents Ages 13–17 (company press release, Business Wire, May 2025)
- Digital Therapeutics Alliance: Freespira product profile (last modified April 2024)
- BF Entry Level (Biofeedback Certification International Alliance)
- The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens, NCT02998502 protocol (2018)
- Allegheny Health Network: Freespira treatment page (service listing only)