Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

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

Study Overview

• Status: Withdrawn
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Acceptance and commitment therapy; Drug: Aripiprazole; Behavioral: Stress management training

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Aripiprazole; Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.	Drug: Aripiprazole; Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Brown Obsessive Compulsive Scale	Change from baseline Y-BOCS score at 8 weeks	0,8week

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Abnormal Involuntary Movement Scale	0,8week

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Director: Zhen Wang, Ph.D M.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: SMHC-OCD-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No