Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000035820
Ethics application status
Approved
Date submitted
13/11/2020
Date registered
18/01/2021
Date last updated
29/05/2023
Date data sharing statement initially provided
18/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an integrated approach of transcranial direct current stimulation and exposure and response prevention for treatment refractory obsessive-compulsive disorder: A case series
Scientific title
Transcranial direct current stimulation and exposure and response prevention for treatment resistant obsessive-compulsive disorder: A case series
Secondary ID [1] 302775 0
None
Universal Trial Number (UTN)
U1111-1261-0991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder 319718 0
Anxiety 319719 0
Depression 319720 0
Condition category
Condition code
Mental Health 317648 317648 0 0
Other mental health disorders
Mental Health 317649 317649 0 0
Anxiety
Mental Health 317650 317650 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation (tDCS) and cognitive behaviour therapy with exposure and response prevention (ERP).

The participants will complete 10 sessions in total of tDCS stimulation to be conducted concurrently with ERP over four weeks, attending the clinic three times per week. Each session will be 50-minutes in duration. The session structure consists of a progress review and preparation for the in-session exposure exercise (approximately 10 minutes), followed by 20-minutes of tDCS commenced in unison with the ERP exercises (see below), 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 pre-supplementary motor area to increase neural activation. The cortical areas will be located using the 10-20 international system for EEG placement. The tDCS stimulation will time out after 20-minutes without disruption to engagement in ERP during the session. The ERP exercises will be continued for approximately 30 mins, leaving the final 10 minutes to debrief and plan any between sessions tasks.
Exposure and Response Prevention.
Exposure and Response Prevention treatments consist of two key elements: 1) exposure to thoughts, images, objects and/or situations that lead to distress and/or are linked to obsessional thinking, and 2) deliberate reduction and/or elimination of the usual compulsive behaviours engaged in once distress or obsessions have been triggered. The 10 session ERP sessions will adhere to the protocol published by Rees, C., & Anderson, R. (2009). Cognitive behavioural treatment manual for OCD: group and individual protocol. In C. Rees [ed.]. Obsessive-compulsive disorder: a practical guide to treatment. Melbourne: IP Communications.
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] 319052 0
Treatment: Devices
Intervention code [2] 319053 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325699 0
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).
Timepoint [1] 325699 0
The Y-BOCS will be administered at baseline (three time points, once a week prior to commencement to establish symptom stability), at the end of weeks 1, 2, and 3 post-commencement of intervention, end of week 4 (2 days after the last session of the intervention (primary endpoint)), and at 3-, and 6-months post-intervention follow-ups,
Primary outcome [2] 325700 0
The Depression Anxiety Stress Scales (DASS-21).
Timepoint [2] 325700 0
The DASS-21 will be administered at baseline (three time points, once a week prior to commencement to establish symptom stability), at the end of weeks 1, 2, and 3 post-commencement of intervention, end of week 4 (2 days after the last session of the intervention (primary endpoint)), and at 3-, and 6-months post-intervention follow-ups,
Primary outcome [3] 325701 0
The MINI International Neuropsychiatric Interview version 7.0.0 for DSM-5 will be used to diagnose and classify OCD.
Timepoint [3] 325701 0
The MINI will be administered at baseline (prior to commencement), at the end of week 4 (2 days after the last session of the intervention (primary endpoint)), and at 3-, and 6-months post-intervention follow-ups,
Secondary outcome [1] 388794 0
The Quality of Life Enjoyment and Satisfaction Questionnaire - short form (Q-LES-Q-SF).
Timepoint [1] 388794 0
The Q-LES-Q-SF will be administered at baseline (prior to commencement), at the end of week 4 (2 days after the last session of the intervention), and at 3-, and 6-months post-intervention follow-ups,
Secondary outcome [2] 388795 0
The Obsessive Beliefs Questionnaire (OBQ-44)
Timepoint [2] 388795 0
The OBQ-44 will be administered at baseline (prior to commencement), at the end of weeks 1, 2, and 3 post-commencement of intervention, end of week 4 (2 days after the last session of the intervention), and at 3-, and 6-months post-intervention follow-ups,
Secondary outcome [3] 388796 0
The Go/No-Go task to measure inhibitory control
Timepoint [3] 388796 0
The Go/No-Go task will be administered at baseline (pre-intervention), at the end of week 4 (2 days post-commencement of intervention), and at 3-, and 6-months post-intervention follow-ups,,
Secondary outcome [4] 388797 0
Intradimensional Extradimensional (ID/ED) set shifting Task (computer version) to measure the ability to shift attention/focus an aspect of cognitive flexibility
Timepoint [4] 388797 0
The ID/ED Task will be administered at baseline (pre-intervention), at the end of week 4 (2 days post-commencement of intervention), and at 3-, and 6-months post-intervention follow-ups,,
Secondary outcome [5] 388798 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] 388798 0
The MINI will be administered at baseline (prior to commencement), at the end of week 4 (2 days after the last session of the intervention), and at 3-, and 6-months post-intervention follow-ups,

Eligibility
Key inclusion criteria
A clinical diagnosis of DSM-5 OCD using the MINI International Neuropsychiatric Interview.
Treatment Refractory, defined as a Yale-Brown Obsessive Compulsive Scale total score of > 16 (moderate to extreme) after two failed pharmacological treatments for OCD, and unsuccessful cognitive behaviour therapy with exposure and response prevention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Participants with a recent history of brain surgery, neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumour), implanted cranial devices, hearing aids (unless they can be removed), active skin lesions on the scalp.
2. History of migraine, epilepsy, seizures, unstable medical and/or psychiatric conditions; history of psychosis or bipolar disorder; high suicide/self-harm risk.
3. Current or past (within the last 1-month) use of benzodiazepines, anticonvulsants, Lithium Carbonate, psychostimulants, dextromethorphan and pseudoephedrine; recreational drug use.
4. Currently undergoing ERP therapy for OCD; any neuromodulation therapy (e.g., ECT, transcranial magnetic stimulation, tDCS) within the last 3-months.
5. Participants who have initiated or changed SSRI/SRI dose in the last 12 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine whether participants have achieved reliable and clinically significant change (not just significant change which is not appropriate for case studies), post-treatment scores on the Y-BOCS will be analysed in accordance with Jacobson and Truax’s (1992) criteria which states that a 10-point reduction on the Y-BOCS is indicative that changes are reliable and not due to measurement error,
For clinically significant change, an established Y-BOCS post-intervention cut-off score of 14 or less will be used (Anderson & Rees, 2007).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2021
Actual
15/02/2021
Date of last participant enrolment
Anticipated
5/06/2023
Actual
18/02/2022
Date of last data collection
Anticipated
18/12/2023
Actual
24/02/2023
Sample size
Target
5
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 31972 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 307192 0
University
Name [1] 307192 0
Curtin University Western Australia
Country [1] 307192 0
Australia
Primary sponsor type
University
Name
Curtin University Western Australia
Address
Kent Street, Bentley
Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 307798 0
Individual
Name [1] 307798 0
Associate Professor Andrea Loftus
Address [1] 307798 0
Kent Street, Bentley
Western Australia, 6102
Country [1] 307798 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307302 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 307302 0
Ethics committee country [1] 307302 0
Australia
Date submitted for ethics approval [1] 307302 0
07/04/2020
Approval date [1] 307302 0
27/05/2020
Ethics approval number [1] 307302 0
HRE2020-0266

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

Contacts
Principal investigator
Name 106750 0
Dr Rebecca Anderson
Address 106750 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 106750 0
Australia
Phone 106750 0
+61 8 92661717
Fax 106750 0
Email 106750 0
[email protected]
Contact person for public queries
Name 106751 0
Peta Green
Address 106751 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 106751 0
Australia
Phone 106751 0
+61 8 92661717
Fax 106751 0
Email 106751 0
[email protected]
Contact person for scientific queries
Name 106752 0
Peta Green
Address 106752 0
Curtin University
Kent St, Bentley
Western Australia, 6102
Country 106752 0
Australia
Phone 106752 0
+61 8 92661717
Fax 106752 0
Email 106752 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.