Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02955654
Collaborator
(none)
0
3
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance and commitment therapy
  • Drug: Aripiprazole
  • Behavioral: Stress management training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder
Anticipated Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Yale Brown Obsessive Compulsive Scale [0,8week]

    Change from baseline Y-BOCS score at 8 weeks

Secondary Outcome Measures

  1. Beck Depression Inventory-II [0,8week]

  2. Acceptance and Action Questionnaire [0,8week]

  3. Treatment Evaluation Inventory-Short Form [0,8week]

  4. Basic life sign [0,8week]

  5. BMI [0,8week]

  6. Abnormal Involuntary Movement Scale [0,8week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT02955654
Other Study ID Numbers:
  • SMHC-OCD-002
First Posted:
Nov 4, 2016
Last Update Posted:
Sep 20, 2019
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2019