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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03067636




Registration number
NCT03067636
Ethics application status
Date submitted
23/02/2017
Date registered
1/03/2017

Titles & IDs
Public title
Retraining Body and Brain to Conquer Compulsions
Scientific title
Retraining the Body and Brain to Conquer Compulsions
Secondary ID [1] 0 0
20160437
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Compulsive Behavior 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Physical Exercise
BEHAVIORAL - Stress management training A
BEHAVIORAL - Stress management training B

Active comparator: Physical exercise + stress management activity A - Eight week program of concurrent exercise and stress management training.

Active comparator: Physical exercise + stress management activity B - Eight week program of concurrent exercise and stress management training.

No intervention: Lifestyle as usual - Eight weeks period with no alteration of usual lifestyle.

Participants randomized to this arm are eligible for re-randomisation to one of the active conditions at the conclusion of week eight.


BEHAVIORAL: Physical Exercise
Physical exercise: Amount of time exercising gradually titrated from 90-minutes in week one to 180-minutes in week eight. Intensity titrated concurrently from 40 - 60% VO2 max in week one to 40 - 90% VO2 max in week eight. Eight week gym membership provided to all participants to facilitate engagement in exercise.

BEHAVIORAL: Stress management training A
Stress management training A: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.

BEHAVIORAL: Stress management training B
Stress management training B: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in hippocampal integrity
Timepoint [1] 0 0
Baseline (0 months), post (2 months)
Secondary outcome [1] 0 0
Change in functional activation during reward processing
Timepoint [1] 0 0
Baseline (0 months), post (2 months)
Secondary outcome [2] 0 0
Change in cortisol awakening reponse
Timepoint [2] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [3] 0 0
Change in affective processing bias
Timepoint [3] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [4] 0 0
Change in risky decision making
Timepoint [4] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [5] 0 0
Change in behavioral compulsivity
Timepoint [5] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [6] 0 0
Change in psychosocial well being
Timepoint [6] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [7] 0 0
Change in physical fitness
Timepoint [7] 0 0
Baseline (0 months), post (2 months), follow up (three months)

Eligibility
Key inclusion criteria
* Voluntary and able to provide informed consent,
* Endorse current behavioural compulsiveness in one of the following domains: alcohol consumption, gambling, eating, checking, washing/cleaning, ordering/arranging,
* Severity of compulsivity falls within mild-moderate range on transdiagnostic YBOCS,
* Level of physical activity fell within WHO Global Recommendations on Physical Activity for Health guidelines definitions of 'sedentary/inactive' across the prior three months, and for a minimum of four of the prior six months.
* Ability to adhere to study procedures.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Lifetime history of DSM-5 defined psychotic illness, severe substance use disorder, severe gambling disorder, binge eating disorder, bulimia nervosa,
* Current major depressive episode or anxiety disorder,
* History of neurological illness or moderate - severe brain injury,
* Have a major unstable medical illness or a chronic pain condition,
* Have a history of cardiovascular disease or musculoskeletal injury or disease that would preclude safe engagement in VO2 max testing or regular physical exercise,
* Lifetime diagnosis of learning difficulty, ADHD, other condition involving cognitive impairment as a primary feature,
* Severe claustrophobia, metallic implant within the body or other contraindication to MRI scanning,
* Shift work employment schedule within the prior 6-months,
* Endocrine disorder, adrenal dysfunction, autoimmune disorder, or other condition known to have a direct effect on the HPA axis,
* Psychoactive or glucocorticoid medications within the past month,
* Currently pregnant or lactating.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University, Brain and Mental Health Lab - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03067636