Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02955654
• Other study ID #: SMHC-OCD-002
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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.

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale	Change from baseline Y-BOCS score at 8 weeks	0,8week
Secondary	Beck Depression Inventory		0,8week
Secondary	Acceptance and Action Questionnaire		0,8week
Secondary	Treatment Evaluation Inventory-Short Form		0,8week
Secondary	Basic life sign		0,8week
Secondary	BMI		0,8week
Secondary	Abnormal Involuntary Movement Scale		0,8week