CBT for Anxiety Sensitivity vs. Disorder-specific CBT: An RCT

NCT03015285 | Completed

• 1 other identifier: 1021903
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adults with high anxiety sensitivity (AS) and a mental health diagnosis of anxiety, depression, or posttraumatic stress will be recruited and will be randomly assigned to either transdiagnostic cognitive behavioural therapy (CBT) for AS or disorder-specific CBT for their primary mental health problem. The study outcomes - AS, anxiety, mood, and substance use symptoms, and functional impairment - will be assessed at pre-and post-treatment and 6 and 12 months post-treatment via standardized self-report measures completed by participants and a standardized diagnostic interview.

Conditions

Generalized Anxiety; Stress Disorder, Posttraumatic; Social Anxiety; Major Depression; Panic Disorder

Outcome Measures

Primary Outcomes (3)

• Change in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3)

  The ASI-3 is an 18-item self-report measure that indexes the amount of fear an individual experiences with respect to anxiety-related body sensations. Participants indicate the extent to which they agree or disagree with each item (e.g., "It scares me when my heart beats rapidly") on a 5-point Likert-type scale.

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.

• Change in primary diagnosis (e.g., anxiety disorder or depression) symptoms

  Primary diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

• Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms

  Comorbid diagnosis (e.g., anxiety disorder or depression) symptoms, as measured by a standardized score on one of the Panic Attack Questionnaire - IV, the Fear Questionnaire, the Generalized Anxiety Disorder - 7-item, the Liebowitz Social Anxiety Scale, the PTSD Checklist for DSM-5, the Pain Anxiety Symptom Scale - 20-item, or the Patient Health Questionnaire - 9-item.

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.

Secondary Outcomes (9)

• Diagnostic status as measured by the Structured Clinical Interview for DSM-5 (SCID-5)

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

• General distress as measured by the Depression Anxiety Stress Scale (DASS-21)

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

• General distress as measured by the Clinical Outcomes in Routine Evaluation measure (CORE-10)

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

• Functional disability as measured by the Sheehan Disability Scale (SDS)

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

• Drinking Motives as measured by the Modified Drinking Motives Questionnaire - Revised (MDMQ-R)

  baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up

Study Arms (2)

Anxiety Sensitivity Cognitive Therapy

EXPERIMENTAL

Participants in the Cognitive Behavioural Therapy for AS condition will complete 8 weekly 50-minute therapy sessions and will be asked to continue with some parts of the intervention (i.e., interoceptive exposure) independently for the next 4 weeks, with short weekly check-ins by phone with their therapist.

Behavioral: Cognitive Behavioural Therapy

Disorder specific Cognitive Therapy

ACTIVE COMPARATOR

Participants in the disorder-specific Cognitive Behavioural Therapy intervention will receive 12 weekly 50-minute therapy sessions following established, evidence-based protocols for each of the disorders included in the study.

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

A type of talk therapy called cognitive behaviour therapy (CBT) will be delivered to both groups.

Anxiety Sensitivity Cognitive Therapy; Disorder specific Cognitive Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate
• High Anxiety Sensitivity (high AS, participants must score ≥23 on the Anxiety Sensitivity Index - 3)
• Live in the surrounding area of Halifax, Nova Scotia or Fredericton, New Brunswick
• Must have a primary diagnosis of one of Agoraphobia, Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), Other Specified Anxiety Disorder, Major Depressive Disorder (MDD), Posttraumatic Stress Disorder (PTSD), or Illness Anxiety Disorder (IAD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5; APA, 2013) as determined by a Structured Clinical Interview for DSM-5 Disorders

You may not qualify if:

• Must not have any contraindications to physical exercise
• Must not be engaged in another current psychotherapy as it may interfere with the treatment under investigation
• Need to be able to attend intervention sessions at Dalhousie University or the University of New Brunswick
• Must not have current Bipolar Disorder and psychosis nor current suicidal intent

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• University of New Brunswick: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Dalhousie University: collaborator

MeSH Terms

Conditions

Generalized Anxiety Disorder; Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Panic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Margo Watt, PhD

  St. Francis Xavier University

  PRINCIPAL INVESTIGATOR

• Janine Olthuis, PhD

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 10, 2017
• Study Start: December 5, 2016
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share