Panic Disorder(CBT)NCT07391943
Self-Guided CBT Mobile App for Treatment-Resistant Panic Disorder (CBT) Cognitive Behavioral Therapy
An observational study of Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Treatment-resistant panic disorder (TRPD) is characterized by persistent panic symptoms despite adequate pharmacological and/or psychotherapeutic treatment. This open-label study is designed to evaluate a self-guided cognitive behavioral therapy (CBT) protocol delivered via a mobile application for adults with TRPD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Experimental - Self-Guided CBT Mobile App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2024to 30 May 2025
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients in the panic and respiratory of the Federal University of Rio de Janeiro
Who may be able to join
- Age 18-60
- DSM-5 diagnosis of TRPD confirmed by psychiatrist
- Ongoing psychiatric follow-up
- Current pharmacological treatment for PD
- Ability to use smartphone/app
Who cannot join
- No PD diagnosis
- Other primary psychiatric disorder
- Severe cognitive impairment
- Inability to use the app
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Self-Guided Cognitive Behavioral Therapy Protocol Via Mobile Application in Patients With Treatment-Resistant Panic Disorder: An Open-Label Trial
Treatment-resistant panic disorder (TRPD) is characterized by persistent panic symptoms despite adequate pharmacological and/or psychotherapeutic treatment. This open-label study is designed to evaluate a self-guided cognitive behavioral therapy (CBT) protocol delivered via a mobile application for adults with TRPD. The intervention consists of eight weekly sessions covering psychoeducation, panic cycle interruption, cognitive restructuring, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An avatar is incorporated to enhance engagement and simulate therapeutic presence. Participants continue their usual psychiatric follow-up and pharmacological treatment throughout the study. Outcomes are assessed at baseline and after completion of the intervention using validated measures of panic severity, anxiety, depression, mindfulness, coping strategies, quality of life, and affect.
Read the detailed description
Panic disorder (PD) is a prevalent anxiety disorder associated with significant functional impairment. Although pharmacotherapy and cognitive behavioral therapy (CBT) are considered first-line treatments, a substantial proportion of patients continue to experience clinically relevant symptoms, characterizing treatment-resistant panic disorder (TRPD). Digital mental health interventions, particularly self-guided CBT delivered via mobile applications, represent a scalable approach to expanding access to evidence-based care.
This open-label study employs an eight-session self-guided CBT protocol delivered through a mobile application for adults diagnosed with TRPD. The intervention is structured into weekly modules addressing psychoeducation about panic disorder, identification and modification of maladaptive cognitions, interruption of the panic cycle, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An interactive avatar is included to simulate therapeutic presence and support user engagement.
Participants are recruited from a specialized outpatient clinic and are required to maintain ongoing psychiatric follow-up and stable pharmacological treatment during the study period. Study assessments are conducted at baseline and at the end of the eight-week intervention. Outcome measures include validated self-report instruments assessing panic severity, anxiety symptoms, depressive symptoms, mindfulness, coping strategies, quality of life, and positive and negative affect
- Conditions
- Panic Disorder
- Being tested
- Experimental - Self-Guided CBT Mobile App
- Keywords
- Panic disorder;, Cognitive behavioral therapy;, Mobile application;, Digital intervention;, Self-guided treatment;, Treatment-resistant panic disorder
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Self-Guided CBT Mobile AppBehavioural
Eight-session manualized CBT protocol delivered via mobile app, including psychoeducation, cognitive restructuring, relaxation, behavioral activation, assertiveness, and life reorganization, with avatar interface to enhance engagement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI) Total Score
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. The BAI is administered to all participants at baseline and at the end of the intervention.
Unit of Measure: Points on a scale (0-63)
Measured: Baseline (Week 1) and Post-intervention (Week 8)
Secondary outcomes (1)
Beck Depression Inventory-II (BDI-II) Total Score
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report instrument used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating greater depression severity. The BDI-II is administered to all participants at baseline and at the end of the intervention.
Unit of Measure: Points on a scale (0-63)
Measured: Baseline (Week 1) and Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Nov 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa Pelucio Ribeiro Barbosa, Universidade Federal do Rio de Janeiro
- Investigators
- Luisa Pelucio, Dr, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391943
- Sponsor's protocol ID
- UFRJ-2025-002
- Acronym
- (CBT)
- Status last verified
- May 2025
- First submitted
- 16 Aug 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Publications
Planert J, Machulska A, Hildebrand AS, Roesmann K, Otto E, Klucken T. Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial. Trials. 2022 May 21;23(1):426. doi: 10.1186/s13063-022-06366-x.
PubMed 35597959Pauley D, Cuijpers P, Papola D, Miguel C, Karyotaki E. Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. Psychol Med. 2023 Jan;53(2):567-579. doi: 10.1017/S0033291721001999. Epub 2021 May 28.
PubMed 34047264Jung HW, Jang KW, Nam S, Kim A, Lee J, Ahn ME, Lee SK, Kim YJ, Shin JK, Roh D. Digital Cognitive Behavioral Therapy for Panic Disorder and Agoraphobia: A Meta-Analytic Review of Clinical Components to Maximize Efficacy. J Clin Med. 2025 Mar 6;14(5):1771. doi: 10.3390/jcm14051771.
PubMed 40095899Modesto-Lowe V, Adams S, Rossi A. Smartphone Applications: Therapy at Your Fingertips. Prim Care Companion CNS Disord. 2024 Aug 20;26(4):24lr03754. doi: 10.4088/PCC.24lr03754. No abstract available.
PubMed 39178019Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2016 Mar 12;3(3):CD011565. doi: 10.1002/14651858.CD011565.pub2.
PubMed 26968204Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Kocalevent RD, Zenger M, Hinz A, Klapp B, Brahler E. Resilient coping in the general population: standardization of the brief resilient coping scale (BRCS). Health Qual Life Outcomes. 2017 Dec 28;15(1):251. doi: 10.1186/s12955-017-0822-6.
PubMed 29282066Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Rus-Calafell M, Ehrbar N, Ward T, Edwards C, Huckvale M, Walke J, Garety P, Craig T. Participants' experiences of AVATAR therapy for distressing voices: a thematic qualitative evaluation. BMC Psychiatry. 2022 May 24;22(1):356. doi: 10.1186/s12888-022-04010-1.
PubMed 35610590Jang B, Yuh C, Lee H, Shin YB, Lee HJ, Kang EK, Heo J, Cho CH. Exploring User Experience and the Therapeutic Relationship of Short-Term Avatar-Based Psychotherapy: Qualitative Pilot Study. JMIR Hum Factors. 2025 Feb 5;12:e66158. doi: 10.2196/66158.
PubMed 39924261Pagliari C, Burton C, McKinstry B, Szentatotai A, David D, Serrano Blanco A, Ferrini L, Albertini S, Castro JC, Estevez S, Wolters M. Psychosocial implications of avatar use in supporting therapy for depression. Stud Health Technol Inform. 2012;181:329-33.
PubMed 22954882Pelucio L, Quagliato LA, Cardoso A, Horato N, Nardi AE. Could the use of web-based applications assist in neuropsychiatric treatment? An umbrella review. BMC Psychol. 2025 Mar 26;13(1):302. doi: 10.1186/s40359-024-02263-x.
PubMed 40140888Pelucio L, Quagliato LA, Nardi AE. Therapist-Guided Versus Self-Guided Cognitive-Behavioral Therapy: A Systematic Review. Prim Care Companion CNS Disord. 2024 Mar 21;26(2):23r03566. doi: 10.4088/PCC.23r03566.
PubMed 38512281
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Self-Guided Cognitive Behavioral Therapy Protocol Via Mobile Application in Patients With Treatment-Resistant Panic Disorder: An Open-Label Trial
- ClinicalTrials.gov ID
- NCT07391943
- Acronym / sponsor ID
- (CBT) / UFRJ-2025-002
- Conditions
- Panic Disorder
- Keywords
- Panic disorder;, Cognitive behavioral therapy;, Mobile application;, Digital intervention;, Self-guided treatment;, Treatment-resistant panic disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment-resistant panic disorder (TRPD) is characterized by persistent panic symptoms despite adequate pharmacological and/or psychotherapeutic treatment. This open-label study is designed to evaluate a self-guided cognitive behavioral therapy (CBT) protocol delivered via a mobile application for adults with TRPD. The intervention consists of eight weekly sessions covering psychoeducation, panic cycle interruption, cognitive restructuring, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An avatar is incorporated to enhance engagement and simulate therapeutic presence. Participants continue their usual psychiatric follow-up and pharmacological treatment throughout the study. Outcomes are assessed at baseline and after completion of the intervention using validated measures of panic severity, anxiety, depression, mindfulness, coping strategies, quality of life, and affect.
Detailed description
Panic disorder (PD) is a prevalent anxiety disorder associated with significant functional impairment. Although pharmacotherapy and cognitive behavioral therapy (CBT) are considered first-line treatments, a substantial proportion of patients continue to experience clinically relevant symptoms, characterizing treatment-resistant panic disorder (TRPD). Digital mental health interventions, particularly self-guided CBT delivered via mobile applications, represent a scalable approach to expanding access to evidence-based care.
This open-label study employs an eight-session self-guided CBT protocol delivered through a mobile application for adults diagnosed with TRPD. The intervention is structured into weekly modules addressing psychoeducation about panic disorder, identification and modification of maladaptive cognitions, interruption of the panic cycle, relaxation techniques, assertiveness training, behavioral strategies, and life reorganization. An interactive avatar is included to simulate therapeutic presence and support user engagement.
Participants are recruited from a specialized outpatient clinic and are required to maintain ongoing psychiatric follow-up and stable pharmacological treatment during the study period. Study assessments are conducted at baseline and at the end of the eight-week intervention. Outcome measures include validated self-report instruments assessing panic severity, anxiety symptoms, depressive symptoms, mindfulness, coping strategies, quality of life, and positive and negative affect
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients in the panic and respiratory of the Federal University of Rio de Janeiro
Key inclusion criteria (5 listed)
- Age 18-60
- DSM-5 diagnosis of TRPD confirmed by psychiatrist
- Ongoing psychiatric follow-up
- Current pharmacological treatment for PD
- Ability to use smartphone/app
Key exclusion criteria (4 listed)
- No PD diagnosis
- Other primary psychiatric disorder
- Severe cognitive impairment
- Inability to use the app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental - Self-Guided CBT Mobile AppEight-session manualized CBT protocol delivered via mobile app, including psychoeducation, cognitive restructuring, relaxation, behavioral activation, assertiveness, and life reorganization, with avatar interface to enhance engagement. | Behavioural | – |
Primary outcome
Beck Anxiety Inventory (BAI) Total Score
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. The BAI is administered to all participants at baseline and at the end of the intervention. Unit of Measure: Points on a scale (0-63)
1 secondary outcome
Beck Depression Inventory-II (BDI-II) Total Score
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 35597959Planert J, Machulska A, Hildebrand AS, Roesmann K, Otto E, Klucken T. Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial. Trials. 2022 May 21;23(1):426. doi: 10.1186/s13063-022-06366-x.
- Results publication: PubMed 34047264Pauley D, Cuijpers P, Papola D, Miguel C, Karyotaki E. Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. Psychol Med. 2023 Jan;53(2):567-579. doi: 10.1017/S0033291721001999. Epub 2021 May 28.
- Results publication: PubMed 40095899Jung HW, Jang KW, Nam S, Kim A, Lee J, Ahn ME, Lee SK, Kim YJ, Shin JK, Roh D. Digital Cognitive Behavioral Therapy for Panic Disorder and Agoraphobia: A Meta-Analytic Review of Clinical Components to Maximize Efficacy. J Clin Med. 2025 Mar 6;14(5):1771. doi: 10.3390/jcm14051771.
- Results publication: PubMed 39178019Modesto-Lowe V, Adams S, Rossi A. Smartphone Applications: Therapy at Your Fingertips. Prim Care Companion CNS Disord. 2024 Aug 20;26(4):24lr03754. doi: 10.4088/PCC.24lr03754. No abstract available.
- Results publication: PubMed 26968204Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2016 Mar 12;3(3):CD011565. doi: 10.1002/14651858.CD011565.pub2.
- Results publication: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Results publication: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Results publication: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Results publication: PubMed 29282066Kocalevent RD, Zenger M, Hinz A, Klapp B, Brahler E. Resilient coping in the general population: standardization of the brief resilient coping scale (BRCS). Health Qual Life Outcomes. 2017 Dec 28;15(1):251. doi: 10.1186/s12955-017-0822-6.
- Results publication: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Results publication: PubMed 35610590Rus-Calafell M, Ehrbar N, Ward T, Edwards C, Huckvale M, Walke J, Garety P, Craig T. Participants' experiences of AVATAR therapy for distressing voices: a thematic qualitative evaluation. BMC Psychiatry. 2022 May 24;22(1):356. doi: 10.1186/s12888-022-04010-1.
- Results publication: PubMed 39924261Jang B, Yuh C, Lee H, Shin YB, Lee HJ, Kang EK, Heo J, Cho CH. Exploring User Experience and the Therapeutic Relationship of Short-Term Avatar-Based Psychotherapy: Qualitative Pilot Study. JMIR Hum Factors. 2025 Feb 5;12:e66158. doi: 10.2196/66158.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa Pelucio, Dr principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) Total Score (time frame: Baseline (Week 1) and Post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07391943, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.