Distance-Based Cognitive-Behavioural Therapy for High Anxiety Sensitivity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
研究概览
简要总结
Anxiety disorders are common pervasive conditions with serious psychosocial implications. Anxiety sensitivity (AS) is one individual characteristic that has been implicated in the onset and maintenance of anxiety disorders (Schmidt et al., 1999). AS is an enduring fear of anxiety-related arousal sensations (i.e., increased heart rate) that arises from the tendency to interpret these sensations catastrophically, believing that they will have serious physical, psychological, or social consequences (Reiss, 1991).
Research has shown the efficacy of CBT in decreasing AS among women with high AS (Watt et al., 2006). Unfortunately, access to effective psychological treatments is limited by a number of barriers such as a lack of treatment availability or qualified clinicians in an area. As such, we are conducting a randomized controlled trial (RCT) of the effectiveness of a distance-based CBT program on decreasing AS among those with high AS. A distance delivery approach (e.g., via telephone) is one way to minimize treatment barriers and increase access to care while still delivering empirically supported treatment. Recent research suggests distance delivery is promising (Lovell et al., 2006).
The RCT will consist of an eight-week structured CBT program based on Watt and Stewart's (2008) brief CBT for AS. The program will include weekly modules on psychoeducation, cognitive restructuring, interoceptive exposure, and relapse prevention. Participants with high AS will be recruited and randomly assigned to the treatment condition or wait-list control (after twelve weeks the wait-list group will receive treatment). In the treatment condition, participants will be assigned weekly reading and homework from the treatment manual. In addition, a therapist will guide them through the treatment by providing individualized support and feedback through weekly half-hour telephone sessions. Treatment outcomes will be assessed through changes in AS levels and anxiety symptoms pre- to post-treatment. Also, participants' satisfaction with the mode of treatment delivery will be assessed. We hypothesize that this treatment program will be effective in reducing high AS and anxiety symptom frequency and severity. We also expect this project to yield information about the utility of distance treatment delivery for mental health care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age
- •high anxiety sensitivity
排除标准
- •cannot speak English
- •illiteracy
- •poor physical health (i.e., inadvisable to participate in physical exercise)
- •engaged in another form of psychotherapy
- •using pharmacotherapy for less than 3 months
- •anyone who changes dose or type of pharmacotherapy during study
- •psychosis
- •suicidal ideation
研究组 & 干预措施
Cognitive Behavioural Therapy
干预措施: Distance-based Cognitive Behavioural Therapy (Other)
Waiting List
结局指标
主要结局
Change from Pre-Treatment in Anxiety Sensitivity Level at Post-Treatment
时间窗: 12 weeks
Change from pre-treatment in participants' anxiety sensitivity level, as measured by the Anxiety Sensitivity Index - 3, will be assessed at post-treatment.
次要结局
- Change from Pre-Treatment in Anxiety Sensitivity Level at 8 weeks(8 weeks)
- Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at 8 weeks(8 weeks)
- Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Drinking Motives at 8 weeks(8 weeks)
- Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Follow-up(20 weeks)
- Change from Pre-Treatment in Social Anxiety Symptoms at Follow-up(20 weeks)
- Change from Pre-Treatment in Participants' Daily Functioning at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Anxiety Sensitivity Level at Follow-up(20 weeks)
- Change from Pre-Treatment in Frequency and Intensity of Physical Exercise at Follow-up(20 weeks)
- Change from Pre-Treatment in in General Anxiety Symptoms at Follow-up(20 weeks)
- Change from Pre-Treatment in Frequency of Pain-Related Anxiety Symptoms at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Frequency of Depressive Symptoms at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Frequency of Binge Drinking at Follow-up(20 weeks)
- Change from Pre-Treatment in Participants' Daily Functioning at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Severity of Panic Symptoms at 8 Weeks(8 weeks)
- Participant Satisfaction with Treatment at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Severity of Panic Symptoms at Post-Treatment(12 weeks)
- Change from Pre-Treatment in in General Anxiety Symptoms at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Social Anxiety Symptoms at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Follow-up(20 weeks)
- Change from Pre-Treatment in Frequency of Binge Drinking at Post-Treatment(12 weeks)
- Change from Pre-Treatment in in General Anxiety Symptoms at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Social Anxiety Symptoms at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Frequency of Binge Drinking at 8 weeks(8 weeks)
- Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Alcohol Expectancies at 8 Weeks(8 weeks)
- Change from Pre-Treatment in Frequency of Depressive Symptoms at Post-Treatment(12 weeks)
- Changes from Pre-Treatment in Neuroticism at 8 weeks(8 weeks)
- Change from Pre-Treatment in Neuroticism at Follow-up(20 weeks)
- Change from Pre-Treatment in Frequency of Depressive Symptoms at Follow-up(20 weeks)
- Change from Pre-Treatment in Frequency and Severity of Posttraumatic Stress Symptoms at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Alcohol Expectancies at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Alcohol Expectancies at Follow-up(20 weeks)
- Change from Pre-Treatment in Participants' Daily Functioning at Follow-up(20 weeks)
- Change from Pre-Treatment in Neuroticism at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Drinking Motives at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Drinking Motives at Follow-up(20 weeks)
- Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Post-Treatment(12 weeks)
- Change from Pre-Treatment in Quantity and Frequency of Alcohol-Related Negative Consequences Experienced at Follow-up(20 weeks)
研究者
Janine Olthuis
Clinical Psychology PhD Candidate
Dalhousie University