Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
研究概览
简要总结
In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. In clinics focused on each of these treatments, the investigators will evaluate these treatments with and without the addition of positive affect promoting activities.
详细描述
The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy. One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy.
This study is a two-clinic randomized clinical trial. Eligible participants will be randomized to standard treatment or standard treatment + positive affect promoting activities. A total of 50 participants (25 per condition) will be randomized in a clinic providing CBT for depression. A total of 40 (20 per condition) will be randomized in a clinic providing CBT for problems of emotion dysregulation. Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample. At pre-treatment, 4-weeks, and 12-weeks, participants will complete symptoms measures in addition to measures of diagnosis-relevant processes (e.g., rumination), personality, therapy skills, treatment engagement, and treatment history. Additionally, participants and providers will complete measures before and after each therapy session to assess alliance, engagement, symptoms, skills, and mood. Sessions will be recorded to later code psychotherapy process measures.
CBT. Clients will participate in a course of CBT for depression. CBT consists of a series of structured, collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views (e.g., "I am worthless"). Treatment will be informed by the primary treatment manual for CBT of depression. Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist.
The protocol for CBT will be to have twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. Clients will have the option of consulting with their therapist or another therapist (which would be likely when a therapist is no longer providing treatment for the study) for up to two booster sessions in the six months following their 12-week acute treatment period.
DBT. Clients will participate in a six-month (24 to 26-week) course of DBT. DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. At study end, participants who wish to continue treatment will be provided with referrals in the community or in the clinic, if therapists are available.
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
盲法说明
Participants will be randomized to treatment as usual (i.e., CBT or DBT) or treatment-as-usual plus positive affect promoting activities (i.e., CBT with PAPA, DBT with PAPA). Randomization will occur within clinic (i.e., one clinic provides CBT, the other provides DBT). In the clinic providing CBT for depression, a total of 50 participants will be randomized (25 each to CBT or CBT with PAPA). In the clinic providing DBT, 40 participants will be randomized (20 each to CBT or CBT with PAPA). Given the treatments under investigation, neither the interventionist nor the participant could be kept unaware of condition.
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
- •Clinic-specific inclusion criteria are as follows. For the clinic providing CBT for depression, participants must meet criteria for a diagnosis of major depressive disorder according to Diagnostic and Statistical Manual-5 (DSM-5). They must also be able to attend in-person sessions or have access to a reliable internet connection to participate in virtual sessions.
- •For the clinic providing DBT, participants must evidence severe emotion dysregulation defined as (1) meeting criteria for borderline personality disorder (BPD) or (2) elevated indicators of borderline personality pathology defined as average scores of 1.5 on the Personality Inventory for DSM-5 (PID-5) Negative Affectivity scale and 1.25 on the Antagonism scale and/or 1.25 on the Disinhibition scale. They must also be willing and able to attend in-person sessions.
- •Across both clinics, the following inclusion and
排除标准
- •will be applied:
- •Inclusion Criteria:
- •18 years old or older
- •residence in the state of Ohio
- •able and willing to give informed consent
- •Exclusion Criteria:
- •current or past diagnosis of bipolar disorder or a psychotic disorder
- •presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
- •currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
- •if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
- •clear indication of secondary gain (e.g., court-ordered treatment)
- •current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis
研究组 & 干预措施
Treatment as Usual
Participants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week.
干预措施: Psychotherapy (Behavioral)
TAU + Positive Affect Promoting Activities
Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions.
干预措施: Psychotherapy, Positive Affect Promoting Activities (Behavioral)
TAU + Positive Affect Promoting Activities
Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions.
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
时间窗: weekly over 12 weeks
16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression.
Weekly Change in Positive and Negative Affect Schedule
时间窗: weekly over 12 weeks
20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect.
次要结局
- Change in Credibility/Expectancy Questionnaire(4 weeks)
- Weekly Change in Working Alliance Inventory(weekly for 12 weeks)
- Weekly Change in Impressions of Skills Scale(weekly over 12 weeks)
研究者
Jennifer Cheavens
Professor
Ohio State University