Retraining Body and Brain to Conquer Compulsions

NCT03067636 | Completed

• 1 other identifier: 20160437
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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:

• drinking alcohol
• gambling
• eating
• washing or cleaning
• checking
• ordering or arranging objects

Conditions

Compulsive Behavior

Outcome Measures

Primary Outcomes (1)

• Change in hippocampal integrity

  Composite score of hippocampal health indices, including volume (structural MRI) and neuronal NAA levels (MRS).

  Baseline (0 months), post (2 months)

Secondary Outcomes (7)

• Change in functional activation during reward processing

  Baseline (0 months), post (2 months)

• Change in cortisol awakening reponse

  Baseline (0 months), post (2 months), follow up (three months)

• Change in affective processing bias

  Baseline (0 months), post (2 months), follow up (three months)

• Change in risky decision making

  Baseline (0 months), post (2 months), follow up (three months)

• Change in behavioral compulsivity

  Baseline (0 months), post (2 months), follow up (three months)

Study Arms (3)

Physical exercise + stress management activity A

ACTIVE COMPARATOR

Eight week program of concurrent exercise and stress management training.

Behavioral: Physical Exercise; Behavioral: Stress management training A

Physical exercise + stress management activity B

ACTIVE COMPARATOR

Eight week program of concurrent exercise and stress management training.

Behavioral: Physical Exercise; Behavioral: Stress management training B

Lifestyle as usual

NO INTERVENTION

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.

Interventions

Physical Exercise BEHAVIORAL

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.

Physical exercise + stress management activity A; Physical exercise + stress management activity B

Stress management training A BEHAVIORAL

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.

Physical exercise + stress management activity A

Stress management training B BEHAVIORAL

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.

Physical exercise + stress management activity B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Monash University, Brain and Mental Health Lab

Melbourne, Victoria, 3800, Australia

Location

MeSH Terms

Conditions

Compulsive Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Rebecca Segrave

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 1, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 20, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)