Clinical trial NCT03015285: CBT for Anxiety Sensitivity vs. Disorder-specific CBT: An RCT
Official title: Comparing the Efficacy of CBT for Anxiety Sensitivity to Disorder-specific CBT in Reducing Mental Health Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety
Stress Disorder, Posttraumatic
Social Anxiety
Major Depression
Panic Disorder
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: University of New Brunswick
name: Canadian Institutes of Health Research (CIHR)
name: Dalhousie University
First posted: 2017-01-10
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
measure: Change in primary diagnosis (e.g., anxiety disorder or depression) symptoms
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
Secondary outcomes:
measure: Diagnostic status as measured by the Structured Clinical Interview for DSM-5 (SCID-5)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: General distress as measured by the Depression Anxiety Stress Scale (DASS-21)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: General distress as measured by the Clinical Outcomes in Routine Evaluation measure (CORE-10)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Functional disability as measured by the Sheehan Disability Scale (SDS)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Drinking Motives as measured by the Modified Drinking Motives Questionnaire - Revised (MDMQ-R)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Hazardous alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Alcohol-related problems as measured by the Short Inventory of Problems (SIP-2R)
timeFrame: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
measure: Treatment alliance as measured by the Working Alliance Inventory - Short-form (WAI-SR)
timeFrame: Only at 12 weeks
measure: Treatment satisfaction as measured by several short researcher-generated questions
timeFrame: Only at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: St. Francis Xavier University
name: Margo Watt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Brunswick
name: Janine Olthuis, PhD
role: PRINCIPAL_INVESTIGATOR
References: