Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04527302
Collaborator
(none)
60
1
2
26.2
2.3

Study Details

Study Description

Brief Summary

This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Direct Current Stimulation (tDCS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Condition or Disease Intervention/Treatment Phase
  • Combination Product: ERP combined with high-definition transcranial direct current stimulation
  • Combination Product: ERP combined with sham tDCS
N/A

Detailed Description

The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT(ERP)combined with tDCS over the prefrontal cortex (mPFC) in treatment of OCD patients. 60 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into two groups (i.e. ERP+active tDCS or ERP+sham tDCS stimulation). The combined treatment will be performed twice a week for the first two weeks. And for the next 4 week, the treatment for the OCD patients will be undertook once a week. There will be 8 times in total. The investigators will assess thhe OCD patients'symptom severity in baseline, after session 2(the first tDCS+ERP), Session 5 ( four sessions of tDCS+ERP) and Session 10 ( eight sessions of tDCS+ERP) . Through the study, Yale-Brown Obsessive Compulsive Scale(Y-BOCS, the Obsessive Compulsive Inventory-Revised (OCI-R),The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS) and the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and EEG.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial of Transcranial Direct Current Stimulation (tDCS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
Actual Study Start Date :
Oct 26, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: active tDCS+exposure based CBT

the exposure and response prevention (ERP) treatment combined with an anode transcranial direct current stimulation over the mPFC will be applied twice a week for the fist two weeks. For the next four weeks, the active tDCS+ERP will be applied once a week. 8 times in total

Combination Product: ERP combined with high-definition transcranial direct current stimulation
Patients will achieve the exposure based CBT for total 10 times excluding 8 sessions of ERP. Structured protocol described by Foa et al., 2012. Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individuals' symptom. Then the next 2 weeks, patients will get ERP session twice a week. From the fourth week to the seventh week, patients weill get ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention. The tDCS device will deliver a direct current of 1.5mA during 20 minutes. Anode electrode will be localized in front of the mPFC on the FpZ point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AF7, AF8, F3, F4).

Sham Comparator: sham tDCS +exposure based CBT

the exposure and response prevention (ERP) treatment combined with an sham transcranial direct current stimulation over the mPFC will be applied twice a week for the fist two weeks. For the next four weeks, the sham tDCS+ERP will be applied once a week. 8 times in total

Combination Product: ERP combined with sham tDCS
Patients will also treated with the same exposure based CBT agenda as the ERP+tDCS group . And simultaneously, thet were also undertook the sham tDCS. The sham tDCS device is the same as the active comparator's except that the sham tDCS will only deliver a current stimulation for the first and last 15 seconds.

Outcome Measures

Primary Outcome Measures

  1. Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score [baseline,2 weeks,4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)]

    It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

Secondary Outcome Measures

  1. Change in Obsessive Compulsive Inventory-Revised(OCI-R) [baseline,2 weeks,4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)]

    It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.

  2. Change in Beck Depression Inventory-II(BDI-II) [baseline,2 weeks,4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)]

    It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.

  3. Change in Beck Anxiety Inventory (BAI) [baseline,2 weeks,4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)]

    It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

  4. Change in Perceived Stress Scale(PSS) [baseline,2 weeks,4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)]

    It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.

  5. Change in Pittsburgh sleep quality index(PSQI) [baseline,2 weeks,4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)]

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

  6. Change in Side-effect questionnaire [2 weeks,4 weeks to 8 weeks(after Session 2, 5, 10)]

    It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

(1) 18-50 years old, with at least 9 years of education, (2) Y-BOCS score ≥16, (3) no history of neurologic disorders, physical illness, and axis I psychiatric disorders other than OCD (without exclusion of anxiety or mild to moderate depression secondary to OCD), (4) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study.

Exclusion Criteria:
  • Any axis I psychiatric disorder comorbidity

  • The inability to receive tDCS because of metallic implants, or history of seizures,or history of head injury, or history of neurosurgery.

  • Participants who have received ECT, rTMS, tDCS and CBT in the past.

  • Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

  • Any current significant medical condition.

  • serious suicide risk

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mental Health Center Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

  • Principal Investigator: Zhen Wang, PhD,MD, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhen Wang, vice-president, Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT04527302
Other Study ID Numbers:
  • SMHC-OCD-008
First Posted:
Aug 26, 2020
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhen Wang, vice-president, Shanghai Mental Health Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022