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Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02955654
Enrollment
0
Registered
2016-11-04
Start date
2017-09-01
Completion date
2018-12-31
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

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.

Interventions

BEHAVIORALAcceptance 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.

DRUGAripiprazole

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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Yale Brown Obsessive Compulsive Scale0,8weekChange from baseline Y-BOCS score at 8 weeks

Secondary

MeasureTime frame
Acceptance and Action Questionnaire0,8week
Treatment Evaluation Inventory-Short Form0,8week
Beck Depression Inventory0,8week
BMI0,8week
Abnormal Involuntary Movement Scale0,8week
Basic life sign0,8week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026