Adding Motivational Interviewing to Cognitive Behavioural Therapy for Severe Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Penn State Worry Questionnaire (PSWQ)
研究概览
简要总结
The current study examines whether change-readiness, and consequently treatment outcome, can be enhanced in Cognitive Behavioral Therapy (CBT) for severe Generalized Anxiety Disorder (GAD) by adding a brief course of Motivational Interviewing (MI adapted for anxiety, Westra & Dozois, 2003) before and during CBT when motivation wanes. 106 individuals with severe GAD will be randomly assigned to receive an equal number of sessions of either MI and CBT (MI-CBT arm) or CBT alone (CBT alone arm). It is expected that the MI-CBT arm relative to the CBT alone arm will show lower levels of resistance in CBT, higher levels of homework compliance and therapeutic alliance, better moment-to-moment interpersonal process, and consequently superior outcomes - both post-treatment and at 6 and 12 month follow-ups.
详细描述
The proposed study builds on the findings of the clinical trial by Westra, Arkowitz and Dozois (2009), and aims to: (1) provide a powerful test of the value of adding MI to CBT for high severity GAD (as pilot data has indicated that individuals with severe GAD may preferentially benefit from the addition of MI to CBT), (2) employ treatment procedures generalizable to clinical practice, and (3) examine the mechanisms underlying any additive treatment benefit. 106 individuals with a principal diagnosis of GAD and of high worry severity will be randomly assigned to receive either 4 sessions of MI followed by 11 sessions of CBT (MI-CBT arm) or 15 sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. Each therapist will deliver all treatment components, treatments will appear seamless to clients, and therapists will be nested within treatment group to control for allegiance effects and avoid cross-contamination of the therapies. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance. Anxiety and related symptoms, motivation, and treatment engagement will be assessed at various points during treatment, and at 6 and 12 months post-treatment. A multi-method approach to assessment will be used, including self-report, clinician-report, clinician-administered, observer-rated, and interview-based measures. Importantly, we will include not only traditional outcome measures, but also process measures (e.g., observer-coded interpersonal behavior, interview-based derivation of client experiences) to investigate possible mechanisms underlying any additive treatment benefit. In addition, all therapy sessions will be videotaped and assessed by independent raters for protocol adherence.
The specific hypotheses are as followed:
Hypothesis 1: Worry, Anxiety, & Related Symptoms. The MI-CBT arm will show greater reductions in worry, anxiety, and related symptoms (depression, disability, maladaptive beliefs about worry, life satisfaction) and a greater percentage of treatment responders (using clinical significance criteria) across the treatment period and at follow-up (FU), compared to the CBT alone arm.
Hypothesis 2: Motivation and Resistance. Over the course of early treatment (i.e., sessions 1 to 4), the MI-CBT arm will demonstrate greater increases in motivation compared to the CBT alone arm. In addition, the MI-CBT arm will exhibit lower in-session resistance during early (sessions 5 & 7), middle (sessions 10 & 12), and late (sessions 15 & 17) phases of treatment.
Hypothesis 3: Homework Compliance. The MI-CBT arm will show greater client- and therapist-rated homework compliance throughout CBT treatment compared to the CBT alone arm.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 16 & 65 years of age
- •Proficient use of English
- •A principle diagnosis of Generalized Anxiety Disorder (GAD)
- •Severe GAD (as measured by clinician severity ratings and PSWQ)
- •Willingness to either remain on stable dosage of psychotropic medication or remain unmedicated throughout their involvement in the clinical trial
排除标准
- •Current of history of psychotic spectrum disorder or bipolar mood disorder
- •Cognitive impairment such as neurodegenerative illness or head injury
- •Current substance abuse and or dependance
- •Concurrent psychotherapy, either individual or group.
结局指标
主要结局
Penn State Worry Questionnaire (PSWQ)
时间窗: up to 4 years
The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) is a widely used measure of worry in GAD treatment outcome studies. It is a 16-item scale assessing trait worry. The PSWQ has been found to possess high internal consistency and temporal stability, as well as good convergent and discriminant validity. It also differentiates individuals with GAD from those with other anxiety disorders (Brown et al., 1992).
次要结局
- Satisfaction with Life Scale (SWLS)(up to 4 years)
- Inventory of Interpersonal Problems (IIP)(up to 4 years)
- Depression Anxiety Stress Scale (DASS)(up to 4 years)
研究者
Henny Westra
Clinical Psychologist, Associate Professor (York University)
York University
