Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Shanghai Mental Health Center

Status: Withdrawn

Conditions: Obsessive-Compulsive Disorder

Treatments: Behavioral: Stress management training; Behavioral: Acceptance and commitment therapy; Drug: Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02955654

SMHC-OCD-002

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Acceptance and commitment therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance and commitment therapy

Aripiprazole

Active Comparator group

Description:

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

Treatment:

Drug: Aripiprazole

Stress management training

Other group

Description:

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.

Treatment:

Behavioral: Stress management training