Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Cognitive Change Sustained at week 12.
研究概览
简要总结
The purpose of this study is to compare two psychological treatments for major depressive disorder (MDD): cognitive-behavioral therapy (CBT) and CBT-Skill Enhanced (CBT-SE). CBT is well-studied, research-supported treatment for depression. CBT-SE is a variant of CBT that places greater focus on helping clients to developing the skills of CBT.
The study will enroll 150 participants with MDD. Participants will be randomized to CBT or CBT-SE, with 75 participants being assigned to each condition. For both conditions, treatment will be provided over 12 weeks, with a 6 month follow-up period.
Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. After entering the study, participants are asked to complete evaluations at 4 weeks and at 12 weeks. They are also asked to respond to self-report instruments before and after each session. Following the 12 week treatment, participants are asked to complete monthly follow-up surveys for 6 months.
The primary objectives of this study are three-fold. The first is to compare the outcomes of the two treatments. The second is to evaluate potential mediators of any treatment differences. The third is to evaluate the process of change in these two versions of CBT.
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
- None
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
- •diagnosis of major depressive disorder (MDD) according to DSM-5 criteria;
- •18 years old or older;
- •residence in the state of Ohio;
- •access to a reliable internet connection (to participate in virtual sessions); and
- •being able and willing to give informed consent.
排除标准
- •current or past diagnosis of bipolar disorder or a psychotic disorder;
- •moderate or severe substance use in the past 6 months (where "moderate" is defined as 4-5 symptoms and "severe" is defined as 6 + symptoms of those listed in DSM-5 for each of the substance-related disorders);
- •current disorder other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered;
- •currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders;
- •clear indication of secondary gain (e.g., court-ordered treatment); and
- •current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.
结局指标
主要结局
Change in Cognitive Change Sustained at week 12.
时间窗: Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.
The Cognitive Change Sustained is a 9-item measure designed to assess the degree to which experienced cognitive change and used cognitive and behavioral strategies in the days leading up to their session. Scores range from 0 to 54, with a higher score indicating greater cognitive change.
Change in Ways of Responding Scale at week 12.
时间窗: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
The Ways of Responding Scale is a measure of the skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with a higher score indicating greater CBT skills.
Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.
时间窗: Weeks 0-12, assessments occurred at every session through week 12.
The Quick Inventory of Depressive Symptoms-Self-Report is a 16-item self-report measure of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Change in CBT Skills - Interview at week 12.
时间窗: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
The CBT skills interview is a semi-structured interview based measure of CBT skills. Assessors evaluate the clients CBT skills use over the past two weeks with seven items. This interview assesses client skills in using coping strategies central to CBT. Scores range from 0 to 28, with a higher score indicating greater CBT skills.
次要结局
- Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.(Weeks 0-12, assessments occurred at intake, week 4, and week 12.)
- Change in Work Social Adjustment Scale at week 12.(Weeks 0-12, assessments occurred at intake, week 4, and week 12.)
- Change in Cognitive Change Immediate at week 12.(Weeks 0-12, assessments occurred at every session through week 12.)
- Change in Competencies of Cognitive Therapy Scale - client version at week 12.(Weeks 0-12, assessments occurred at intake, week 4, and week 12.)
- Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.(Weeks 0-12, assessments occurred at intake, week 4, and week 12.)
研究者
Daniel R. Strunk
Professor
Ohio State University