Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement in Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months
研究概览
简要总结
The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
详细描述
- BACKGROUND AND SIGNIFICANCE.
The most effective psychological treatment for Obsessive-Compulsive Disorder (OCD) is Exposure and Response Prevention (ERP), which entails confronting obsessional triggers (i.e., exposure) and resisting urges to ritualize (response prevention). Although successful, these techniques are challenging and provoke high levels of anxiety. This may contribute to the fact that between 25% and 50% of patients with access to ERP refuse treatment, drop out prematurely, or do not adhere to the treatment instructions and show attenuated response. Given the effectiveness of ERP techniques, developing ways to make them more tolerable and increase patient adherence, while not compromising therapeutic integrity, is an important next step in OCD treatment research. Recent investigations have addressed whether adding medications, cognitive therapy, or motivational Interviewing to ERP improves outcome and adherence; yet to date, no consensus has emerged regarding the degree to which these combination treatments are more effective than ERP monotherapy. Acceptance and Commitment Therapy (ACT), which has recently been studied for OCD, offers new hope for addressing the tolerability and adherence issues with ERP. Specifically, ACT uses acceptance and mindfulness processes to foster a willingness to experience unwanted inner experiences (e.g., obsessional thoughts, anxiety). These acceptance and mindfulness processes are consistent with ERP, but they are hypothesized to increase engagement in exposure exercises beyond ERP alone. There is evidence for this claim from a randomized trial which demonstrated that ACT, without in-session exposure, had clinical response rates in the 55-65% range at posttreatment and three month follow-up using an intent to treat analysis. Additionally, drop-out and refusal rates were low at 12.2% and treatment acceptability at posttreatment was near the maximum on the scale 4.3 out of 5. In this study, for experimental reasons, ACT did not include in-session ERP. However, the most theoretically and practically consistent use of ACT for OCD is as a context from which to conduct exposure therapy or ERP. While ACT focuses on processes (e.g., acceptance, defusion, values) that are distinct from those involved in ERP (e.g., habituation, cognitive change), an important goal of both treatments is to broaden the patient's engagement with feared stimuli. In fact, ACT procedures have been shown to increase involvement in difficult activities, including participating in exposure therapy for anxiety disorders and willingness to experience unwanted obsessive thoughts. Thus, building ACT techniques into ERP is likely to help patients (a) engage in ERP tasks, (b) confront high levels of anxiety without using escape/avoidance strategies, and (c) resist rituals. The aim of the proposed study is to evaluate whether integrating ACT increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. 2. STUDY DESIGN AND HYPOTHESES.
Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up. 3. METHODS
3a. Sample Size and Recruitment. The investigators aimed for an intent-to-treat sample of 60 adults across two sites: The Center for Clinical Research at Utah State University (USU) and the Anxiety and Stress Disorders Clinic at the University of North Carolina, Chapel Hill (UNC). Patients were recruited via advertisement of the study and via referrals from primary care and mental health providers familiar with the treatment centers. The USU Center (Twohig) and the UNC Clinic (Abramowitz) are well known research-oriented treatment clinics in their regions. USU is within a 1:30 minute drive of two million people and travel for treatment is common given the rural nature of the area. Also, no other known entity recruits participants with OCD in this area. The Raleigh-Durham-Chapel Hill area of NC is home to over one million people, and the UNC Clinic receives a steady stream of inquiries for treatment. Patient advocacy groups and associations that post research trials on the Internet were contacted to further publicize the study.
3b. Establishing Diagnoses. All diagnoses were established by trained interviewers using the Mini International Neuropsychiatric Interview (MINI).
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
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current DSM-IV-TR principal diagnosis of OCD for at least 1 year
- •Willing to attend all 16 therapy sessions
- •Fluent in English
- •No previous Cognitive Behavior Therapy or Acceptance and Commitment Therapy for OCD
- •If on medication for OCD, willing to remain at a fixed dose while participating in the study
排除标准
- •Current severe depression or suicidal ideation
- •Current substance abuse or dependence
- •Current mania, psychosis, or borderline or schizotypal personality disorder
研究组 & 干预措施
ACT plus ERP
Sessions 1 and 2 involved information-gathering, discussion of the ACT model of OCD and ERP, and introduction to self-monitoring of rituals. Session 3 involved the development of an exposure hierarchy and response prevention plan, and further explanation of the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. Exposure practices (sessions 4-16) were procedurally similar to the ERP condition, but focused on the facilitation of ACT processes rather than on fear extinction. Homework exposure practice was linked to the participant's goals and values. Session 16 included an ACT model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges.
干预措施: ACT plus ERP (Behavioral)
ERP alone
ERP followed Kozak and Foa's treatment manual. Sessions 1 and 2 included information-gathering, psychoeducation about the cognitive-behavioral model of OCD and rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-16 included in-session prolonged and repeated gradual exposure therapy (in vivo and imaginal as needed), the assignment of daily exposure practices for between-sessions, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 also addressed discontinuation and relapse prevention.
干预措施: ERP alone (Behavioral)
结局指标
主要结局
Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months
时间窗: Follow-up (6 months after the end of treatment)
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks
时间窗: Posttreatment (8 weeks after Baseline)
Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74.
次要结局
- Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Treatment Credibility and Expectancy Questionnaire(Session 4 (2 weeks following Baseline))
- Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months(Follow-up (6 months after the end of treatment))
- Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session(Sessions 1-16 (Twice per week for 8 weeks following Baseline))
- Change from Baseline Distress Tolerance Scale (DTS) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Session-level Change in Interpretation of Intrusions Inventory (III) at each session(Sessions 1-16 (twice per week for 8 weeks following Baseline))
- Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Change from Posttreatment Distress Tolerance Scale (DTS) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Posttreatment Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Baseline Obsessive Beliefs Questionnaire (OBQ) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Change from Baseline Interpretation of Intrusions Inventory (III) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Change from Posttreatment Interpretation of Intrusions Inventory (III) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Posttreatment Obsessive Beliefs Questionnaire (OBQ) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Baseline Dimensional Obsessive Compulsive Scale (DOCS) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Change from Posttreatment Dimensional Obsessive Compulsive Scale (DOCS) at 6 months(Follow-up (6 months after the end of treatment))
- Change from Baseline Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 8 weeks(Posttreatment (8 weeks after Baseline))
- Session-level Change in Patient EX/RP Adherence Scale - Therapist Rated at each session beginning with session 4(Sessions 4-16 (twice per week for 6 weeks following week 2 of treatment))
- Session-level Change in Dimensional Obsessive Compulsive Scale at each session(Sessions 1-16 (twice per week for 8 weeks following Baseline))
研究者
Michael Twohig, Ph.D.
Professor
Utah State University
