Group-based Acceptance and Commitment Therapy for Obsessive Compulsive Disorder: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (YBOCS)
研究概览
简要总结
The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults.
Researchers will compare intervention to control group to see if those who attend the group therapy have better results than control group.
Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).
- Participants will not have any medication adjustment during therapy
- Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.
详细描述
The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults. The main questions it aims to answer are:
- Can ACT in groups help decrease the severity of OCD symptoms?
- Can ACT in groups help increase psychological flexibility in this group?
- Can ACT in groups help increase quality of life in this group?
Researchers will compare intervention (n=16) to control group (n=8) to see if those who attend the group therapy have better results than control group.
We will perform an unequal randomization in a 2:1 ratio, in blocks of 6, for allocation to each group. The assessor of the outcomes of interest will be blinded to the group to which the participant was assigned
Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).
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)
盲法说明
Only the team member who will apply the questionnaires/scales will be masked.
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
- •OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS
排除标准
- •Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy
研究组 & 干预措施
Group psychotherapy with ACT
16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR)
干预措施: Group acceptance and commitment therapy (ACT) (Other)
Treatment as usual
Patients will follow their usual treatment, without adding ACT-based group psychotherapy
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
时间窗: 10 months (4-month intervention + 6-month follow-up)
Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms.
次要结局
- Depression Anxiety and Stress Scale (DASS)(10 months (4-month intervention + 6-month follow-up))
- Affective Style Questionnaire (ASQ)(10 months (4-month intervention + 6-month follow-up))
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)(10 months (4-month intervention + 6-month follow-up))
- Clinical Global Impressions (CGI) Scale,(10 months (4-month intervention + 6-month follow-up))
- AAQ for Obsessions and Compulsions (AAQ-OC)(10 months (4-month intervention + 6-month follow-up))
- Acceptance and Commitment Therapy Processes (CompACT)(10 months (4-month intervention + 6-month follow-up))
研究者
Luciana Midori Samezima
Ms
Universidade Federal do Paraná