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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03067636
Ethics application status
Date submitted
23/02/2017
Date registered
1/03/2017
Date last updated
14/05/2021

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
Behaviour - Physical Exercise
Behaviour - Stress management training A
Behaviour - 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.


Behaviour: 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.

Behaviour: 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.

Behaviour: 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
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in hippocampal integrity - Composite score of hippocampal health indices, including volume (structural MRI) and neuronal NAA levels (MRS).
Timepoint [1] 0 0
Baseline (0 months), post (2 months)
Secondary outcome [1] 0 0
Change in functional activation during reward processing - fMRI Monetary Incentive Delay Task
Timepoint [1] 0 0
Baseline (0 months), post (2 months)
Secondary outcome [2] 0 0
Change in cortisol awakening reponse - Salivary cortisol
Timepoint [2] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [3] 0 0
Change in affective processing bias - BeanFest
Timepoint [3] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [4] 0 0
Change in risky decision making - Balloon Analogue Risk Task
Timepoint [4] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [5] 0 0
Change in behavioral compulsivity - Transdiagnositc YBOCS
Timepoint [5] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [6] 0 0
Change in psychosocial well being - Battery of self-report mental health and well being questionnaires assessing: symptoms of depression and anxiety, experiential avoidance, tolerance of uncertainly, impulsivity, obsession beliefs, well being, self efficacy, quality of life, and quality of inter-personal support.
Timepoint [6] 0 0
Baseline (0 months), post (2 months), follow up (three months)
Secondary outcome [7] 0 0
Change in physical fitness - VO2 max
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Following the realisation that many aspects of the way we live our life, such as our diet,
activity levels, and amount of screen time, can have a potent impact on mental health and
brain functioning 'lifestyle' based interventions have become topical in medical research. In
particular, much scientific attention has been devoted to the impact of physical exercise and
various stress reduction techniques on mood disorders. We aim to extend this work and
investigate their impact on compulsivity.

We will do this by conducting a pilot proof-of-principal intervention study. The study will
compare the impact of eight-weeks of:

1. regular physical exercise + stress management activity A,

2. regular physical exercise + stress management activity B,

3. lifestyle as usual.

The participant cohort will be adults who endorse mild-moderate behavioural compulsivity on
one of the following domains:

- drinking alcohol

- gambling

- eating

- washing or cleaning

- checking

- ordering or arranging objects
Trial website
https://clinicaltrials.gov/show/NCT03067636
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03067636