Obsessive-Compulsive DisorderNCT02955654
Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder
A study testing Acceptance and commitment therapy, Aripiprazole and Stress management training in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Acceptance and commitment therapy, Aripiprazole and Stress management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
The purpose of this study is to determine whether acceptance and commitment therapy is effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Acceptance and commitment therapy, Aripiprazole, Stress management training
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
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.
AripiprazoleDrug
Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
Stress management trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy | Experimental | 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. Receives: Behavioral: Acceptance and commitment therapy |
| Aripiprazole | Active comparator | Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks. Receives: Drug: Aripiprazole |
| Stress management training | Other | 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. Receives: Behavioral: Stress management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
Change from baseline Y-BOCS score at 8 weeks
Measured: 0,8week
Secondary outcomes (6)
Beck Depression Inventory
Measured: 0,8week
Acceptance and Action Questionnaire
Measured: 0,8week
Treatment Evaluation Inventory-Short Form
Measured: 0,8week
Basic life sign
Measured: 0,8week
BMI
Measured: 0,8week
Abnormal Involuntary Movement Scale
Measured: 0,8week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Sep 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Loss of finacial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen Wang, Ph.D M.D, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955654
- Sponsor's protocol ID
- SMHC-OCD-002
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2016
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy in SSRI-Resistant Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02955654
- Acronym / sponsor ID
- SMHC-OCD-002
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of finacial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Behavioral: Acceptance and commitment therapyPatients 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. |
| Aripiprazole | Active comparator | Drug: AripiprazolePatients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks. |
| Stress management training | Other | Behavioral: Stress management trainingPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyPatients 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. | Behavioural | Acceptance and commitment therapy |
| AripiprazolePatients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks. | Drug | Aripiprazole |
| Stress management trainingPatients 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. | Behavioural | Stress management training |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: 0,8week
Change from baseline Y-BOCS score at 8 weeks
6 secondary outcomes
Beck Depression Inventory
Time frame: 0,8week
Acceptance and Action Questionnaire
Time frame: 0,8week
Treatment Evaluation Inventory-Short Form
Time frame: 0,8week
Basic life sign
Time frame: 0,8week
BMI
Time frame: 0,8week
Abnormal Involuntary Movement Scale
Time frame: 0,8week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Wang, Ph.D M.D study director
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy, Aripiprazole and Stress management training in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (time frame: 0,8week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.