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

Browse trials for

• Anxiety Disorders 4,868
• Panic Disorder 250
• Stress Disorders, Post-Traumatic 2,239

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 65 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.

Study arms

• Experimental
  Anxiety Sensitivity Cognitive Therapy

  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

• Active comparator
  Disorder specific Cognitive Therapy

  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

• BehavioralCognitive Behavioural Therapy

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

Primary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

Secondary outcomes

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

   Administered by a trained researcher blind to treatment condition. The SCID-5 has been widely used in numerous research studies and is well empirically validated. At each time point, we will assess participants' primary and secondary diagnoses as well as the overall number of diagnoses for which they qualify.

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

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

   The Depression Anxiety Stress Scales - 21. The DASS-21 is a shortened version of the 42-item DASS and is composed of three subscales: Depression, Anxiety, and Stress. Individuals indicate the extent to which a particular negative emotional state (e.g., "I found it difficult to relax") has applied to them over the past week on a 4-point Likert-type scale (0 = Did not apply to me at all to 3 = Applied to me very much or most of the time).

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

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

   Clinical Outcomes in Routine Evaluation (CORE-10) is a brief, 10-item self-report measure designed to assess common presentations of symptoms of psychological distress. Participants are asked to indicate how often in the past week they have felt a series of symptoms (e.g., "I have felt tense, anxious, or nervous") on a 5-point Likert-type scale.

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

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

   The Sheehan Disability Scale will be used to measure functional impairment in three domains: work/school, family life, and social. Using a 10-point visual analogue scale, participants rate the extent to which their general mental health symptoms disrupt their work/school, family life/responsibilities, and social life. Participants also indicate the number of days their mental health symptoms caused them to miss school/work as well as the number of days their symptoms had caused their performance to be reduced during the past week. The SDS is well-validated and widely used with a range of populations.

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

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

   The MDMQ-R measures drinking motives. Respondents estimate how often they drink for the reason specified in each item on a 5-point Likert-type scale.

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

6. Hazardous alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)

   Despite being designed as a screening tool, the AUDIT is commonly used to assess alcohol use problems pre- and post-treatment. The AUDIT is a 10-item self-report measure that asks participants to report on their frequency of alcohol use, binge drinking, and alcohol-dependent behaviours. Responses are scored on 5-point Likert-type scales. Finally, participants report if they have experienced problems caused by alcohol use on a 3-point Likert-type scale.

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

7. Alcohol-related problems as measured by the Short Inventory of Problems (SIP-2R)

   The SIP-2R consists of the three items from each of five subscales. Participants are asked to indicate the frequency with which they have experienced each of 15 drinking-related problems on a 4-point Likert-type scale.

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

8. Treatment alliance as measured by the Working Alliance Inventory - Short-form (WAI-SR)

   The WAI-SR is a 12-item self-report questionnaire comprised of three subscales: Goals, or agreement on the goals of therapy, Tasks, or agreement on the tasks of therapy, and Bonds, or the bond between the therapist and the client. Participants indicate the extent to which each of these statements reflects their experience on a 5-point Likert-type scale.

   Time frame: Only at 12 weeks

9. Treatment satisfaction as measured by several short researcher-generated questions

   In order to assess satisfaction with the different components of treatment, participants will answer a series of open-ended questions about their experience (e.g., "Was the treatment convenient for you to engage in?"; "Did you find the telephone therapy sessions helpful?") after all parts of treatment are completed (i.e., at 12 weeks).

   Time frame: Only at 12 weeks

Individual participant data

Plan to share: No — Data will only be shared between investigators at the two study sites once it has been de-identified and entered into a data analytic program in order to protect participants' privacy and confidentiality.