Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000990921
Ethics application status
Approved
Date submitted
10/07/2020
Date registered
1/10/2020
Date last updated
1/10/2020
Date data sharing statement initially provided
1/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of direct current brain stimulation on symptoms associated with obsessive-compulsive disorder.
Scientific title
Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: An examination of treatment effectiveness and acceptability.
Secondary ID [1] 301448 0
Nil known
Universal Trial Number (UTN)
U1111-1253-5211
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder 317859 0
Anxiety 318484 0
Depression 318485 0
Condition category
Condition code
Mental Health 315905 315905 0 0
Other mental health disorders
Mental Health 316486 316486 0 0
Anxiety
Mental Health 316487 316487 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial Direct Current Stimulation (tDCS): The participants randomly allocated to the active tDCS group will complete 10 sessions in total of tDCS stimulation spread over 4 weeks, attending the clinic 3 times per week. Each session will take 30 minutes to complete, allowing for set up and placement of the electrodes and 20-mins of stimulation. The participants will receive 20 minutes of stimulation using a constant current of 2mA. Cathodal stimulation will be applied over the left Orbito Frontal Cortex to decrease neural activation, and anodal stimulation will be applied over the right pre-supplementary motor area to increase neural activation. These cortical areas will be located using the 10-20 international system for EEG placement.
The Intervention will be administered by a post-graduate Clinical Psychology Trainee under the supervision of two senior academics with expertise in clinical and neuropsychology, and experience in tDCS delivery.
Session attendance, and drop out will be monitored and noted for each client and included in the data set.
Intervention code [1] 317820 0
Treatment: Devices
Comparator / control treatment
A sham transcranial direct current stimulation (tDCS) device will be used with the participants randomly allocated to the control group. Participants will complete 10 sessions in total of sham stimulation spread over 4 weeks, attending the clinic 3 times per week. In each session, the participants will receive 30 seconds of stimulation at the start and end of the 20-minute session. This ramp up /ramp down period, is used so the participant feels some sensation of tDCS but they do not receive the full 20 -minutes of constant stimulation at 2mA.
Control group
Placebo

Outcomes
Primary outcome [1] 324115 0
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).
Timepoint [1] 324115 0
The Y-BOCS will be administered pre-intervention, at the end of weeks 2 and 3 of the four-week intervention phase, and then post-intervention at the end of week 4 (2 days after the last session), which will be the primary endpoint. Follow-up measures will be conducted at the end of the three-month-, and six-month period to measure maintenance of gains..
Primary outcome [2] 324116 0
The Depression Anxiety Stress Scales (DASS-21).
Timepoint [2] 324116 0
The DASS-21 will be administered pre-intervention, at the end of weeks 2 and 3 of the four-week intervention phase, and then post-intervention at the end of week 4 (2 days after the last session),which will be the primary endpoint, Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Primary outcome [3] 324117 0
The MINI International Neuropsychiatric Interview version 7.0.0 for DSM-5 will be used to diagnose and classify OCD.
Timepoint [3] 324117 0
The MINI will be administered at pre- and post-intervention at the end of week 4 (2 days after the last session),which will be the primary endpoint, Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Secondary outcome [1] 383799 0
The Quality of Life Enjoyment and Satisfaction Questionnaire - short form (Q-LES-Q-SF).
Timepoint [1] 383799 0
The Q-LES-Q-SF will be administered pre- and post-intervention at the end of week 4 (2 days after the last session), Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Secondary outcome [2] 383800 0
The Obsessive Beliefs Questionnaire (OBQ-44)
Timepoint [2] 383800 0
The OBQ-44 will be administered pre- and post-intervention at the end of week 4 (2 days after the last session), Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Secondary outcome [3] 383801 0
The Go/No Go task to measure inhibitory control
Timepoint [3] 383801 0
The Go/No Go task will be administered pre- and post-intervention at the end of week 4 (2 days after the last session), Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Secondary outcome [4] 383802 0
The intradimensional/extradimensional (IDED) shift task to measure the ability to shift focus.
Timepoint [4] 383802 0
The IDED will be administered pre- and post-intervention at the end of week 4 (2 days after the last session), Follow-up measures will be conducted at the end of the three-month-, and six-month period.
Secondary outcome [5] 386566 0
The MINI International Neuropsychiatric Interview version 7.0.0 for DSM-5 will be used to assess and classify any other co-morbid mental health conditions.
Timepoint [5] 386566 0
The MINI will be administered at pre- and post-intervention at the end of week 4 (2 days after the last session), Follow-up measures will be conducted at the end of the three-month-, and six-month period.

Eligibility
Key inclusion criteria
A clinical diagnosis of DSM-5 OCD using the MINI International Neuropsychiatric Interview.
A Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score of > 16 (moderate to extreme).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Include (1) Recent history of brain surgery, (2) active skin disease on the scalp, (3) history of migraine, (4) history of epilepsy, (5) unstable medical condition (e.g., uncontrolled diabetes), (6) participants who have initiated or changed SSRI/SRI dose in the last 12 weeks (7) metal implants in the head/brain, (8) currently using a hearing aid, (9) taking Lithium Carbonate, (10) currently undergoing exposure and response prevention for obsessive-compulsive disorder, and (11) high suicide/self-harm risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted utilising central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
There are no suitable tDCS trials to guide a power analysis for this study, however, a G*Power calculation indicated that 30 participants (15 per group) are required to detect a moderate effect (a = .05; power = .80). We will aim to recruit 40 participants (20 per group) to allow for attrition.
Data analysis
A series of generalised linear mixed models (GLMMs) will be used to determine whether active and sham tDCS differ at pre vs post intervention on the outcome measures. The GLMMs will be completed using the GENLINMIXED procedure in SPSS (Version 22). GLMMs are used to control for outcome variables when the data is not normally distributed, and includes random and fixed effects (McCulloch & Neuhaus, 2005). This study has one random effect (participant) and three fixed effects: Group (tDCS vs Sham), time (pre, post, follow-up), and Group x Time interaction. GLMMs are robust against unequal groups (Krueger & Tian, 2004). Unlike repeated measures ANOVA, GLMMs do not rely on participants providing data at all times (pre, post & follow-up) reducing the impact of participant attrition on statistical power.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2020
Actual
Date of last participant enrolment
Anticipated
10/09/2021
Actual
Date of last data collection
Anticipated
7/03/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 30689 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 305883 0
University
Name [1] 305883 0
Curtin University Western Australia
Country [1] 305883 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
Kent Street, Bentley
Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 306338 0
Individual
Name [1] 306338 0
Associate Professor Andrea Loftus
Address [1] 306338 0
Curtin University
Kent Street, Bentley
Western Australia, 6102
Country [1] 306338 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306144 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 306144 0
Ethics committee country [1] 306144 0
Australia
Date submitted for ethics approval [1] 306144 0
07/04/2020
Approval date [1] 306144 0
27/05/2020
Ethics approval number [1] 306144 0
HRE2020-0266

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102862 0
Dr Rebecca Anderson
Address 102862 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 102862 0
Australia
Phone 102862 0
+61 8 92661717
Fax 102862 0
Email 102862 0
[email protected]
Contact person for public queries
Name 102863 0
Peta E Green
Address 102863 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 102863 0
Australia
Phone 102863 0
+61 8 92661717
Fax 102863 0
Email 102863 0
[email protected]
Contact person for scientific queries
Name 102864 0
Peta E Green
Address 102864 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 102864 0
Australia
Phone 102864 0
+61 8 92661717
Fax 102864 0
Email 102864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, up to 25-years
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To conduct secondary analyses on the data that is consistent with the purpose of this study's data collection.
How or where can data be obtained?
Access subject to approvals by Principal Investigator [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.