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