Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

NCT ID: NCT02955654

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-12-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

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

Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.

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.

Group Type: OTHER

Stress management training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Aripiprazole

Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhen Wang, Ph.D M.D

Role: STUDY_DIRECTOR

Shanghai Mental Health Center

Other Identifiers

SMHC-OCD-002

Identifier Type: -

Identifier Source: org_study_id