Panic DisorderNCT05462184
Predictors and Moderators of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy for Panic Disorder
A study testing Cognitive-Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) in people with Panic Disorder and Cognitive-Behavioral Therapy, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: Panic disorder is one of the most prevalent anxiety disorders and with the greatest impact on the functionality of patients. Knowing variables that influence the therapies outcome can improve the results of the interventions and reduce the socio-health cost. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder, Cognitive-Behavioral Therapy, Acceptance and Commitment Therapy
- What is being tested?
- Cognitive-Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to 31 Jul 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Panic Disorder diagnostic DSM-5.
- Between 18 and 65 years of age.
- Medication-free or no change in the last month.
- Not undergoing other psychotherapy.
Who cannot join
- Primary diagnosis of a disorder other than panic disorder.
- Active suicidal ideation.
- Substance abuse or dependence.
- Cognitive impairment, neurological disorders or intellectual disability.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Príncipe de Asturias University Hospital
Alcalá de Henares, Madrid, 28805
About this study
Official title: Predictors and Moderators of Effectiveness of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy in Group Format for Patients With Panic Disorder
Objective: Panic disorder is one of the most prevalent anxiety disorders and with the greatest impact on the functionality of patients. Knowing variables that influence the therapies outcome can improve the results of the interventions and reduce the socio-health cost. The current study examined possible predictors and moderators of outcome in cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Method: Eighty patients with diagnostic of panic disorder received 12 group sessions of CBT or ACT and were assessed with several measures at baseline, 12 weeks post-treatment and 24 weeks post-treatment.
Read the detailed description
Panic disorder is characterized by the presence of recurrent and unexpected panic attacks, that is, the person suddenly suffers attacks of intense fear. Panic disorder has a significant prevalence and presents frequent comorbidity with other disorders (anxiety, depression or substance abuse, among others). In addition, its course is usually chronic, leading to a significant functional deterioration for the person, with a deterioration in their quality of life. In addition, it generates high direct and indirect costs (loss of working days, visits to emergency services, medical visits, health expenses, etc.).
The psychological therapy of choice for the treatment of panic disorder is cognitive behavioral therapy (CBT). However, around 25% of patients do not respond successfully to CBT treatment, relapse at the end of therapy or need other additional treatments (Brown \& Barlow, 1995; Hofmann et al., 2012). In this context, the study of predictors and moderators of efficacy in psychotherapy is especially relevant, with acceptance and commitment therapy (ACT) being an alternative with growing empirical support. In addition, the group therapy format provides unique qualities and advantages, both at a psychotherapeutic level and in terms of saving resources.
The objective of this study was to analyze the effect of different potentially predictive and moderating variables on the efficacy of cognitive-behavioral therapy and acceptance and commitment therapy in a group format for patients with panic disorder. To this end, a randomized, single-centre, prospective, controlled clinical trial with a 24-week follow-up was carried out.
The sample consisted of 80 patients with panic disorder, randomized into two treatment groups: the experimental group, which received acceptance and commitment therapy, and the active comparator control group, which received cognitive-behavioral therapy. Panic disorder severity was assessed using the Panic Disorder Severity Scale-Self Report (PDSS-SR), fear of physical symptoms using the Body Sensations Questionnaire, BSQ) and the frequency of catastrophic thoughts using the Agoraphobic Cognitions Questionnaire (ACQ). These three measurements were taken before and at the end of treatment, as well as at three months of follow-up.
The potential predictors and moderators analyzed were age, gender, duration of the disorder, motivation to change using the University of Rhode Island Change Assessment Scale (URICA), responsibility through the Five Factor Personality Inventory (Neo Five Factor Inventory, NEO-FFI) and experiential avoidance with the Acceptance and Action Questionnaire-II (AAQ-II).
Participants were randomized to the two treatment groups (CBT or ACT). In both groups, the patients received 12 therapy sessions of 1 hour and 30 minutes duration, with a weekly frequency.
Data analysis was performed using the statistical computing software R version 3.5 and its random forest and Ime4 packages. Statistical analysis was performed by intention to treat (ITT). For the comparison of the sociodemographic and clinical characteristics between the two groups, the Student's t-test was used for the quantitative variables and the Chi-square test for the qualitative variables. To test the hypotheses, a model was designed to perform the analysis of covariance (ANCOVA) type III, which incorporates interactions, considering the time factor of the treatments as a covariate. Post-hoc analyzes were performed with the multcomp package built into the R statistical computing software, which allows performing Tukey-type simultaneous comparison tests for generalized models and generalized mixed models.
- Conditions
- Panic Disorder, Cognitive-Behavioral Therapy, Acceptance and Commitment Therapy, Predictor
- Being tested
- Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT)Behavioural
Acceptance and Commitment Therapy (ACT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Active comparator | CBT followed Craske \& Barlow´s (2007) manual, which contains a session-by-session description treatment of panic disorder with CBT. The treatment included the following components: (a) psychoeducation about the nature of anxiety and panic, (b) diaphragmatic breathing training, (c) identification and correction of maladaptive thoughts about anxiety and its consequences, (d) exposure to interoceptive sensations, and (e) exposure to feared situations. Receives: Behavioral: Cognitive-Behavioral Therapy (CBT) |
| Acceptance and Commitment Therapy (ACT) | Experimental | ACT was conducted following Eifert \& Forsyth´s (2005) manual, which contains a session-by-session description of the application of ACT to anxiety disorders. In the current study, exercises were adapted to the panic disorder treatment. The treatment included the following components: (a) acceptance of internal experiences, (b) cognitive defusion, (c) work with the "self as context", (d) contact with the present moment, (e) work with life values, and values, and (f) commitment to action. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline level of Severity of Panic Disorder at 12 weeks and 24 weeks post-treatment.
It is evaluated through the Panic Disorder Severity Scale-Self Report. It is a self-administered scale whose objective is to determine the level of severity of panic disorder in the last month. It is composed of 7 items, which explore: (1) frequency of panic attacks, (2) distress provoked by panic attacks, (3) anticipatory anxiety, (4) agoraphobic fear and avoidance, (5) fear and/or avoidance of situations, (6) impairment and/or interference in work activity, and (7) impairment and/or interference in social activity. The patient answers using a Likert-type scale from 0 to 4, with 0 being the minimum and 4 the maximum severity of symptoms. It provides a profile of the intensity and presence of symptoms in the last month.
Measured: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
Change from Baseline degree of Fear of Physical Symptoms at 12 weeks and 24 weeks post-treatment.
It is evaluated through the Body Sensations Questionnaire. It is a self-administered questionnaire composed of 17 items plus 1 final open-ended item. The subject responds to each item according to a 5-point Likert-type scale. This questionnaire evaluates the degree of fear or concern generated by each of the physical symptoms that occur during panic attacks. The final score is obtained by calculating the mean of the 17 items. A high score is indicative of a great fear of the physical symptoms.
Measured: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
Change from Baseline frequency of Agoraphobic Cognitions at 12 weeks and 24 weeks post-treatment.
It is evaluated through the Agoraphobic Cognitions Questionnaire. It is a self-administered questionnaire composed of 14 items (plus a final open-ended item) on a 5-point Likert-type scale. It evaluates the frequency with which the patient has catastrophic thoughts about the negative consequences of experiencing anxiety when anxious. It is composed of two subscales: catastrophic thoughts about physical consequences of anxiety (heart attack, tumor, etc.) and catastrophic thoughts about social and behavioral consequences (making a fool of oneself, going crazy, etc.). An overall score is obtained by calculating the mean of the total items and the scores on the two subscales: physical level and social-behavioral level.
Measured: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study startMar 2014
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Responsible party
- Principal investigator, Leticia León-Quismondo, University of Alcala
- Investigators
- Leticia León-Quismondo, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462184
- Sponsor's protocol ID
- PAN-MOD
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice guideline for the treatment of patients with panic disorder. Work Group on Panic Disorder. American Psychiatric Association. Am J Psychiatry. 1998 May;155(5 Suppl):1-34. No abstract available.
PubMed 9585731Andlin-Sobocki P, Wittchen HU. Cost of anxiety disorders in Europe. Eur J Neurol. 2005 Jun;12 Suppl 1:39-44. doi: 10.1111/j.1468-1331.2005.01196.x. No abstract available.
PubMed 15877777Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
PubMed 16199119Craske MG, Niles AN, Burklund LJ, Wolitzky-Taylor KB, Vilardaga JC, Arch JJ, Saxbe DE, Lieberman MD. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators. J Consult Clin Psychol. 2014 Dec;82(6):1034-48. doi: 10.1037/a0037212. Epub 2014 Jul 7.
PubMed 24999670Gloster AT, Sonntag R, Hoyer J, Meyer AH, Heinze S, Strohle A, Eifert G, Wittchen HU. Treating Treatment-Resistant Patients with Panic Disorder and Agoraphobia Using Psychotherapy: A Randomized Controlled Switching Trial. Psychother Psychosom. 2015;84(2):100-109. doi: 10.1159/000370162. Epub 2015 Feb 21.
PubMed 25722042Niles AN, Wolitzky-Taylor KB, Arch JJ, Craske MG. Applying a novel statistical method to advance the personalized treatment of anxiety disorders: A composite moderator of comparative drop-out from CBT and ACT. Behav Res Ther. 2017 Apr;91:13-23. doi: 10.1016/j.brat.2017.01.001. Epub 2017 Jan 4.
PubMed 28110111Wolitzky-Taylor KB, Arch JJ, Rosenfield D, Craske MG. Moderators and non-specific predictors of treatment outcome for anxiety disorders: a comparison of cognitive behavioral therapy to acceptance and commitment therapy. J Consult Clin Psychol. 2012 Oct;80(5):786-99. doi: 10.1037/a0029418. Epub 2012 Jul 23.
PubMed 22823858
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Moderators of Effectiveness of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy in Group Format for Patients With Panic Disorder
- ClinicalTrials.gov ID
- NCT05462184
- Acronym / sponsor ID
- PAN-MOD
- Conditions
- Panic Disorder, Cognitive-Behavioral Therapy, Acceptance and Commitment Therapy, Predictor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias
- Study start
- Mar 2014 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 18 Jul 2022 (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.
Objective: Panic disorder is one of the most prevalent anxiety disorders and with the greatest impact on the functionality of patients. Knowing variables that influence the therapies outcome can improve the results of the interventions and reduce the socio-health cost. The current study examined possible predictors and moderators of outcome in cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Method: Eighty patients with diagnostic of panic disorder received 12 group sessions of CBT or ACT and were assessed with several measures at baseline, 12 weeks post-treatment and 24 weeks post-treatment.
Detailed description
Panic disorder is characterized by the presence of recurrent and unexpected panic attacks, that is, the person suddenly suffers attacks of intense fear. Panic disorder has a significant prevalence and presents frequent comorbidity with other disorders (anxiety, depression or substance abuse, among others). In addition, its course is usually chronic, leading to a significant functional deterioration for the person, with a deterioration in their quality of life. In addition, it generates high direct and indirect costs (loss of working days, visits to emergency services, medical visits, health expenses, etc.).
The psychological therapy of choice for the treatment of panic disorder is cognitive behavioral therapy (CBT). However, around 25% of patients do not respond successfully to CBT treatment, relapse at the end of therapy or need other additional treatments (Brown \& Barlow, 1995; Hofmann et al., 2012). In this context, the study of predictors and moderators of efficacy in psychotherapy is especially relevant, with acceptance and commitment therapy (ACT) being an alternative with growing empirical support. In addition, the group therapy format provides unique qualities and advantages, both at a psychotherapeutic level and in terms of saving resources.
The objective of this study was to analyze the effect of different potentially predictive and moderating variables on the efficacy of cognitive-behavioral therapy and acceptance and commitment therapy in a group format for patients with panic disorder. To this end, a randomized, single-centre, prospective, controlled clinical trial with a 24-week follow-up was carried out.
The sample consisted of 80 patients with panic disorder, randomized into two treatment groups: the experimental group, which received acceptance and commitment therapy, and the active comparator control group, which received cognitive-behavioral therapy. Panic disorder severity was assessed using the Panic Disorder Severity Scale-Self Report (PDSS-SR), fear of physical symptoms using the Body Sensations Questionnaire, BSQ) and the frequency of catastrophic thoughts using the Agoraphobic Cognitions Questionnaire (ACQ). These three measurements were taken before and at the end of treatment, as well as at three months of follow-up.
The potential predictors and moderators analyzed were age, gender, duration of the disorder, motivation to change using the University of Rhode Island Change Assessment Scale (URICA), responsibility through the Five Factor Personality Inventory (Neo Five Factor Inventory, NEO-FFI) and experiential avoidance with the Acceptance and Action Questionnaire-II (AAQ-II).
Participants were randomized to the two treatment groups (CBT or ACT). In both groups, the patients received 12 therapy sessions of 1 hour and 30 minutes duration, with a weekly frequency.
Data analysis was performed using the statistical computing software R version 3.5 and its random forest and Ime4 packages. Statistical analysis was performed by intention to treat (ITT). For the comparison of the sociodemographic and clinical characteristics between the two groups, the Student's t-test was used for the quantitative variables and the Chi-square test for the qualitative variables. To test the hypotheses, a model was designed to perform the analysis of covariance (ANCOVA) type III, which incorporates interactions, considering the time factor of the treatments as a covariate. Post-hoc analyzes were performed with the multcomp package built into the R statistical computing software, which allows performing Tukey-type simultaneous comparison tests for generalized models and generalized mixed models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Active comparator | Behavioral: Cognitive-Behavioral Therapy (CBT)CBT followed Craske \& Barlow´s (2007) manual, which contains a session-by-session description treatment of panic disorder with CBT. The treatment included the following components: (a) psychoeducation about the nature of anxiety and panic, (b) diaphragmatic breathing training, (c) identification and correction of maladaptive thoughts about anxiety and its consequences, (d) exposure to interoceptive sensations, and (e) exposure to feared situations. |
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)ACT was conducted following Eifert \& Forsyth´s (2005) manual, which contains a session-by-session description of the application of ACT to anxiety disorders. In the current study, exercises were adapted to the panic disorder treatment. The treatment included the following components: (a) acceptance of internal experiences, (b) cognitive defusion, (c) work with the "self as context", (d) contact with the present moment, (e) work with life values, and values, and (f) commitment to action. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Panic Disorder diagnostic DSM-5.
- Between 18 and 65 years of age.
- Medication-free or no change in the last month.
- Not undergoing other psychotherapy.
Key exclusion criteria (4 listed)
- Primary diagnosis of a disorder other than panic disorder.
- Active suicidal ideation.
- Substance abuse or dependence.
- Cognitive impairment, neurological disorders or intellectual disability.
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 |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Behavioural | Cognitive-Behavioral Therapy (CBT) |
| Acceptance and Commitment Therapy (ACT) | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
Change from Baseline level of Severity of Panic Disorder at 12 weeks and 24 weeks post-treatment.
Time frame: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
It is evaluated through the Panic Disorder Severity Scale-Self Report. It is a self-administered scale whose objective is to determine the level of severity of panic disorder in the last month. It is composed of 7 items, which explore: (1) frequency of panic attacks, (2) distress provoked by panic attacks, (3) anticipatory anxiety, (4) agoraphobic fear and avoidance, (5) fear and/or avoidance of situations, (6) impairment and/or interference in work activity, and (7) impairment and/or interference in social activity. The patient answers using a Likert-type scale from 0 to 4, with 0 being the minimum and 4 the maximum severity of symptoms. It provides a profile of the intensity and presence of symptoms in the last month.
Change from Baseline degree of Fear of Physical Symptoms at 12 weeks and 24 weeks post-treatment.
Time frame: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
It is evaluated through the Body Sensations Questionnaire. It is a self-administered questionnaire composed of 17 items plus 1 final open-ended item. The subject responds to each item according to a 5-point Likert-type scale. This questionnaire evaluates the degree of fear or concern generated by each of the physical symptoms that occur during panic attacks. The final score is obtained by calculating the mean of the 17 items. A high score is indicative of a great fear of the physical symptoms.
Change from Baseline frequency of Agoraphobic Cognitions at 12 weeks and 24 weeks post-treatment.
Time frame: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.
It is evaluated through the Agoraphobic Cognitions Questionnaire. It is a self-administered questionnaire composed of 14 items (plus a final open-ended item) on a 5-point Likert-type scale. It evaluates the frequency with which the patient has catastrophic thoughts about the negative consequences of experiencing anxiety when anxious. It is composed of two subscales: catastrophic thoughts about physical consequences of anxiety (heart attack, tumor, etc.) and catastrophic thoughts about social and behavioral consequences (making a fool of oneself, going crazy, etc.). An overall score is obtained by calculating the mean of the total items and the scores on the two subscales: physical level and social-behavioral level.
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 18 Jul 2022.
- Background: PubMed 9585731Practice guideline for the treatment of patients with panic disorder. Work Group on Panic Disorder. American Psychiatric Association. Am J Psychiatry. 1998 May;155(5 Suppl):1-34. No abstract available.
- Background: PubMed 15877777Andlin-Sobocki P, Wittchen HU. Cost of anxiety disorders in Europe. Eur J Neurol. 2005 Jun;12 Suppl 1:39-44. doi: 10.1111/j.1468-1331.2005.01196.x. No abstract available.
- Background: PubMed 16199119Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
- Background: PubMed 24999670Craske MG, Niles AN, Burklund LJ, Wolitzky-Taylor KB, Vilardaga JC, Arch JJ, Saxbe DE, Lieberman MD. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators. J Consult Clin Psychol. 2014 Dec;82(6):1034-48. doi: 10.1037/a0037212. Epub 2014 Jul 7.
- Background: PubMed 25722042Gloster AT, Sonntag R, Hoyer J, Meyer AH, Heinze S, Strohle A, Eifert G, Wittchen HU. Treating Treatment-Resistant Patients with Panic Disorder and Agoraphobia Using Psychotherapy: A Randomized Controlled Switching Trial. Psychother Psychosom. 2015;84(2):100-109. doi: 10.1159/000370162. Epub 2015 Feb 21.
- Background: PubMed 28110111Niles AN, Wolitzky-Taylor KB, Arch JJ, Craske MG. Applying a novel statistical method to advance the personalized treatment of anxiety disorders: A composite moderator of comparative drop-out from CBT and ACT. Behav Res Ther. 2017 Apr;91:13-23. doi: 10.1016/j.brat.2017.01.001. Epub 2017 Jan 4.
- Background: PubMed 22823858Wolitzky-Taylor KB, Arch JJ, Rosenfield D, Craske MG. Moderators and non-specific predictors of treatment outcome for anxiety disorders: a comparison of cognitive behavioral therapy to acceptance and commitment therapy. J Consult Clin Psychol. 2012 Oct;80(5):786-99. doi: 10.1037/a0029418. Epub 2012 Jul 23.
- Individual participant dataSharing planned: No
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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.
Leticia León-Quismondo principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) in people with Panic Disorder and Cognitive-Behavioral Therapy, run by University of Alcala at 1 site in Spain.
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 4 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 18 Jul 2022. 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 Spain. 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?
Change from Baseline level of Severity of Panic Disorder at 12 weeks and 24 weeks post-treatment. (time frame: Baseline, 12 weeks post-treatment and 24 weeks post-treatment.). The study lists 3 primary outcomes in all. 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 NCT05462184, which also lists 7 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 18 Jul 2022.