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

Major Depression Clinical Trial

Official title: Comparing the Efficacy of CBT for Anxiety Sensitivity to Disorder-specific CBT in Reducing Mental Health Symptoms: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

While our previous work has provided some evidence that cognitive behavioural therapy (CBT) for anxiety sensitivity(AS) reduces mental health symptoms, the current study aims to determine whether this treatment works as well as traditional disorder-specific CBT (which aims to treat the specific disorder a person presents with, such as CBT for panic disorder for someone with panic disorder) in treating anxiety and depression. This will be the first study to have looked at this question.

Our objectives are to determine:

1. if there is a difference in the extent to which CBT for AS vs. disorder-specific CBT reduces, in the short- and long-term, a) AS, b) symptoms of a person's primary and secondary mental health problems, and c) functional disability (i.e., a person's ability to function in day-to-day life);

2. if the two treatments lead to differences in the number of participants who no longer meet the requirements for a diagnosis (of their primary or secondary mental health problems) in the short- and long-term; and

3. if the treatments are seen as similarly satisfactory by participants.

Eligible participants will be randomly assigned (via online random number generator) to either transdiagnostic CBT for AS or disorder-specific CBT for their primary mental health problem. Both CBT interventions are evidence-based, guided by treatment manuals/workbooks (provided to participants), and involve 12 weekly therapy sessions. The AS intervention will also involve a physical exercise component (i.e., running/brisk walking 3x/week starting on week 5) and participants will be provided with a wearable fitness device designed to provide physiological indices of arousal and track physical activity. 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder, Major
• Disease
• Generalized Anxiety
• Major Depression
• Panic Disorder
• Social Anxiety
• Stress Disorder, Posttraumatic
• Stress Disorders, Post-Traumatic

• NCT number: NCT03015285
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Contact: Sherry Stewart, PhD
• Phone: 9024943793
• Email: sherry.stewart@dal.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2017
• Completion date: August 2019