Comparing the Efficacy of CBT for Anxiety Sensitivity to Disorder-specific CBT in Reducing Mental Health Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms
研究概览
简要总结
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.
详细描述
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:
- 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);
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cognitive Behavioural Therapy (Behavioral)
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.
干预措施: Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Change in comorbid diagnosis (e.g., anxiety disorders or depression) symptoms
时间窗: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
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.
Change in anxiety sensitivity: the Anxiety Sensitivity Index - 3 (ASI-3)
时间窗: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up.
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.
Change in primary diagnosis (e.g., anxiety disorder or depression) symptoms
时间窗: baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up
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.
次要结局
- Alcohol-related problems as measured by the Short Inventory of Problems (SIP-2R)(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)
- Hazardous alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)(baseline (i.e., start of study), 12 weeks, 6 months, and 12 months follow-up)
- 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)
- Treatment satisfaction as measured by several short researcher-generated questions(Only at 12 weeks)
- 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)
- Treatment alliance as measured by the Working Alliance Inventory - Short-form (WAI-SR)(Only at 12 weeks)