Obsessive-Compulsive DisorderNCT04527302
Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)
A study testing ERP combined with high-definition active tDCS in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- ERP combined with high-definition active tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2020to 30 Aug 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years old, with at least 9 years of education, (2) Y-BOCS score ≥16, (3) no history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary), (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 (5) no previous exposure to ERP or tDCS.
Who cannot join
- history of serious medical, neurological illness or other psychotic disorders other than OCD
- 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.
- serious suicide risk
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Zhen Wang
About this study
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)
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).
Read the 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). Over a two-month period, all patients are received 10 sessions of individual CBT, including 8 sessions of concurrent tDCS with ERP (tDCS+ERP). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive MRI scan and EEG.
The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- ERP combined with high-definition active tDCS, ERP combined with sham tDCS
- Keywords
- transcranial direct current stimulation, cognitive-behavioral therapy, Exposure and Response /Ritual Prevention
- 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.
ERP combined with high-definition active tDCSCombination product
The active tDCS +ERP referred to a period of tDCS applied in the first 20 minutes of the ERP treatment (the tDCS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tDCS+ERP treatment.
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).
ERP combined with sham tDCSCombination product
Patients will get the same CBT setting as the active tDCS group and they were applied the sham tDCS cocurrently with ERP. 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 in order to produce somatic sensation in patients similar to that induced by the active tDCS.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS+exposure based CBT | Active comparator | The exposure and response prevention (ERP) treatment concurrently with an anode transcranial direct current stimulation over the mPFC will be applied 8 times (tDCS+ERP, 8sessions) in the whole treatment. Receives: Combination Product: ERP combined with high-definition active tDCS |
| sham tDCS +exposure based CBT | Sham comparator | the exposure and response prevention (ERP) treatment concurrently with an sham transcranial direct current stimulation over the mPFC will be applied 8 times (sham tDCS+ERP, 8 sessions) in the whole treatment. Receives: Combination Product: ERP combined with sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was represented by the percent reduction of Y-BOCS scores
We defined the tDCS+ERP treatment response as the percent reduction of Y-BOCS scores greater than or equal to 35%.
Measured: baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)
Secondary outcomes (6)
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
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.
Measured: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Beck Depression Inventory(BDI)
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.
Measured: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Beck Anxiety Inventory (BAI)
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.
Measured: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Perceived Stress Scale(PSS)
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.
Measured: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Pittsburgh sleep quality index(PSQI)
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).
Measured: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Side-effect questionnaire
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.
Measured: 2 weeks，4 weeks to 8 weeks(after Session 2, 5, 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start26 Oct 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
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.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527302
- Sponsor's protocol ID
- SMHC-OCD-008
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04527302
- Acronym / sponsor ID
- SMHC-OCD-008
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- transcranial direct current stimulation, cognitive-behavioral therapy, Exposure and Response /Ritual Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 26 Aug 2020 (actual)
- 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.
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).
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). Over a two-month period, all patients are received 10 sessions of individual CBT, including 8 sessions of concurrent tDCS with ERP (tDCS+ERP). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive MRI scan and EEG.
The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| active tDCS+exposure based CBT | Active comparator | Combination Product: ERP combined with high-definition active tDCSThe exposure and response prevention (ERP) treatment concurrently with an anode transcranial direct current stimulation over the mPFC will be applied 8 times (tDCS+ERP, 8sessions) in the whole treatment. |
| sham tDCS +exposure based CBT | Sham comparator | Combination Product: ERP combined with sham tDCSthe exposure and response prevention (ERP) treatment concurrently with an sham transcranial direct current stimulation over the mPFC will be applied 8 times (sham tDCS+ERP, 8 sessions) in the whole treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-50 years old, with at least 9 years of education, (2) Y-BOCS score ≥16, (3) no history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary), (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 (5) no previous exposure to ERP or tDCS.
Key exclusion criteria (5 listed)
- history of serious medical, neurological illness or other psychotic disorders other than OCD
- 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.
- serious suicide risk
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 |
|---|---|---|
| ERP combined with high-definition active tDCSThe active tDCS +ERP referred to a period of tDCS applied in the first 20 minutes of the ERP treatment (the tDCS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tDCS+ERP treatment. 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). | Combination product | active tDCS+exposure based CBT |
| ERP combined with sham tDCSPatients will get the same CBT setting as the active tDCS group and they were applied the sham tDCS cocurrently with ERP. 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 in order to produce somatic sensation in patients similar to that induced by the active tDCS. | Combination product | sham tDCS +exposure based CBT |
Primary outcome
The primary outcome was represented by the percent reduction of Y-BOCS scores
Time frame: baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)
We defined the tDCS+ERP treatment response as the percent reduction of Y-BOCS scores greater than or equal to 35%.
6 secondary outcomes
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
Time frame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Beck Depression Inventory(BDI)
Time frame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Beck Anxiety Inventory (BAI)
Time frame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Perceived Stress Scale(PSS)
Time frame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Pittsburgh sleep quality index(PSQI)
Time frame: baseline，2 weeks，4 weeks to 8 weeks(pre-treatment, after Session 2, 5, 10)
Change in Side-effect questionnaire
Time frame: 2 weeks，4 weeks to 8 weeks(after Session 2, 5, 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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, PhD,MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERP combined with high-definition active tDCS in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, PhD,MD (+86 34773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was represented by the percent reduction of Y-BOCS scores (time frame: baseline，2 weeks，4 weeks to 8 weeks (pre-treatment, after Session 2, 5, 10)). 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 16 Apr 2024.