Predictors and Moderators of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy for Panic Disorder

NCT05462184 | Completed DMC

• 1 other identifier: PAN-MOD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Panic Disorder; Cognitive-Behavioral Therapy; Acceptance and Commitment Therapy; Predictor

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 12 weeks post-treatment and 24 weeks post-treatment.

Study Arms (2)

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.

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.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Cognitive-Behavioral Therapy (CBT) BEHAVIORAL

Cognitive-Behavioral Therapy (CBT)

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Primary diagnosis of a disorder other than panic disorder.
• Active suicidal ideation.
• Substance abuse or dependence.
• Cognitive impairment, neurological disorders or intellectual disability.

Sponsors & Collaborators

• University of Alcala: lead
• Hospital Universitario Principe de Asturias: collaborator

Study Sites (1)

Príncipe de Asturias University Hospital

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (7)

• 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.

  PMID: 9585731 BACKGROUND

• Andlin-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.

  PMID: 15877777 BACKGROUND

• Butler 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.

  PMID: 16199119 BACKGROUND

• Craske 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.

  PMID: 24999670 BACKGROUND

• Gloster 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.

  PMID: 25722042 BACKGROUND

• Niles 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.

  PMID: 28110111 BACKGROUND

• Wolitzky-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.

  PMID: 22823858 BACKGROUND

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leticia León-Quismondo

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 18, 2022
• Study Start: March 1, 2014
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)