Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

NCT02955654 | Withdrawn DMC

• 1 other identifier: SMHC-OCD-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale

  Change from baseline Y-BOCS score at 8 weeks

  0,8week

Secondary Outcomes (6)

• Beck Depression Inventory

  0,8week

• Acceptance and Action Questionnaire

  0,8week

• Treatment Evaluation Inventory-Short Form

  0,8week

• Basic life sign

  0,8week

• BMI

  0,8week

Study Arms (3)

Acceptance and commitment therapy

EXPERIMENTAL

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.

Behavioral: Acceptance and commitment therapy

Aripiprazole

ACTIVE COMPARATOR

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

Drug: Aripiprazole

Stress management training

OTHER

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.

Behavioral: Stress management training

Interventions

Acceptance and commitment therapy 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.

Acceptance and commitment therapy

Aripiprazole DRUG

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

Aripiprazole

Stress management training 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.

Stress management training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65;
• no less than 9 years in education;
• a DSM-IV diagnosis of OCD
• moderately symptomatic (Yale-Brown Obsessive Compulsive Scale score≥16)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Acceptance and Commitment Therapy; Aripiprazole

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhen Wang, Ph.D M.D

  Shanghai Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 4, 2016
• Study Start: September 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 14, 2022

Record last verified: 2017-04