Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Not Applicable

Withdrawn

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Acceptance and commitment therapy; Drug: Aripiprazole; Behavioral: Stress management training

• Registration Number: NCT02955654
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

The purpose of this study is to determine whether acceptance and commitment therapy is effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.

Detailed Description

The patients who were SSRI-resistant will be randomized to ACT, aripiprazole, or SMT. Independent evaluators, blind to treatment,will evaluate patients during the study.The Yale-Brown Obsessive Compulsive Scale (YBOCS)will be used to measure OCD severity.

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Status Verified: 2017-04
• Study Start: 2017-09-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. age between 18 and 65;
2. no less than 9 years in education;
3. a DSM-IV diagnosis of OCD
4. moderately symptomatic (Yale-Brown Obsessive Compulsive Scale score≥16)
5. received at least two kinds of SSRIs at optimal dose for more than 12 weeks An optimal dose is described as following: clomipramine hydrochloride, at least 225 mg/d;fluoxetine, at least 60 mg/d; paroxetine hydrochloride, at least 60 mg/d; sertraline hydrochloride, at least 200 mg/d; fluvoxamine, at least 250 mg/d; citalopram hydrobromide,at least 60 mg/d; and escitalopram oxalate, at least 40 mg/d.Patients who are unable to tolerate the supposed optimal doses were also eligible if at their maximally tolerated dose.

Exclusion Criteria

1. with comorbid Axis I psychiatric disorders
2. drug abuse in the last 3 months
3. HAMD>25
4. too severe to receive ACT or evaluation
5. at high risk of suicide
6. pregnant or prepare for pregnancy
7. with somatic disorder
8. received aripiprazole(≥10mg for 8weeks) or ACT(8 times within 2 months) before
9. treated with no more than one kind of SSRI before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and commitment therapy	Acceptance and commitment therapy	Patients randomized to ACT will receive weekly 45-50 minute sessions delivered over 8 weeks by a therapist. ACT will include mindfulness,learning new methods to handle problems，acceptance of thoughts and feelings, learning to disempower thoughts and feelings, and values-based committed action.
Aripiprazole	Aripiprazole	Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
Stress management training	Stress management training	Patients randomized to SMT group will be received 2 introductory sessions and 15 treatment sessions. SMT will include training of stress manage-ment skills, progressive muscle relaxation,positive imagery, assertiveness training, and problem solving.

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale	0,8week	Change from baseline Y-BOCS score at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Treatment Evaluation Inventory-Short Form	0,8week
Beck Depression Inventory	0,8week
Acceptance and Action Questionnaire	0,8week
BMI	0,8week
Basic life sign	0,8week
Abnormal Involuntary Movement Scale	0,8week