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Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acceptance and commitment therapy
Aripiprazole
Stress management training
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    Acceptance and commitment therapy

    Aripiprazole

    Stress management training

    Arm 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.

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

    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.

    Outcomes

    Primary Outcome Measures

    Yale Brown Obsessive Compulsive Scale
    Change from baseline Y-BOCS score at 8 weeks

    Secondary Outcome Measures

    Beck Depression Inventory
    Acceptance and Action Questionnaire
    Treatment Evaluation Inventory-Short Form
    Basic life sign
    BMI
    Abnormal Involuntary Movement Scale

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    September 9, 2022
    Sponsor
    Shanghai Mental Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02955654
    Brief Title
    Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder
    Official Title
    Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Loss of finacial support
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Mental Health Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acceptance and commitment therapy
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Aripiprazole
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
    Arm Title
    Stress management training
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Acceptance and commitment therapy
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole
    Intervention Description
    Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stress management training
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Yale Brown Obsessive Compulsive Scale
    Description
    Change from baseline Y-BOCS score at 8 weeks
    Time Frame
    0,8week
    Secondary Outcome Measure Information:
    Title
    Beck Depression Inventory
    Time Frame
    0,8week
    Title
    Acceptance and Action Questionnaire
    Time Frame
    0,8week
    Title
    Treatment Evaluation Inventory-Short Form
    Time Frame
    0,8week
    Title
    Basic life sign
    Time Frame
    0,8week
    Title
    BMI
    Time Frame
    0,8week
    Title
    Abnormal Involuntary Movement Scale
    Time Frame
    0,8week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhen Wang, Ph.D M.D
    Organizational Affiliation
    Shanghai Mental Health Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

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