Compulsive BehaviorNCT03067636
Retraining Body and Brain to Conquer Compulsions
A study testing Physical Exercise, Stress management training A and Stress management training B in people with Compulsive Behavior, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Compulsive Behavior
- What is being tested?
- Physical Exercise, Stress management training A and Stress management training B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2017to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Monash University, Brain and Mental Health Lab
Melbourne, Victoria, 3800
About this study
Official title: Retraining the Body and Brain to Conquer Compulsions
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:
Read more
- regular physical exercise + stress management activity A,
- regular physical exercise + stress management activity B,
- 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
Read the detailed description
This study is investigating the impact of regular physical exercise and stress management activities on mental health and brain function. It is specifically focusing on how engaging in these activities might impact activity in brain circuits associated with compulsivity, and help to reduce compulsive patterns of behaviour.
A compulsive behaviour is something that we do regularly, feel pressured to do, and have difficulty stopping even though it is not benefiting us. Having compulsive patterns of behaviour is very common. It's been estimated that as many as 80% of the general population experience compulsivity at some point in their lives. That's most of us! Compulsive behaviours range in severity from mild to entrenched, and can take many forms. For example, gambling too often or washing ones hands excessively. For some people what starts out as a mild pattern of behaviour, such as a glass of wine every night after a stressful day, can develop into a problem, like alcohol dependence. As so many people experience mild to moderate compulsivity it would be helpful to have accessible evidence-based strategies that reduce compulsive tendencies.
One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health and mental well being. Other candidates are specific stress management activities. Certain stress management techniques, such as brain training, meditation, psycho-education, music therapy, yoga, and guided relaxation, can promote optimal mental health, improve cognitive functioning and help keep the body's physiological arousal systems within a healthy range. Some stress management activities may also help to reduce compulsive behavioural patterns. Importantly, as physical exercise increases neuroplasticity (i.e. malleability of the brain), engaging in regular exercise may enhance the effectiveness of concurrent stress management activities.
This research study is investigating the impact of eight-weeks of regular physical exercise paired with two different stress management activities on brain health, mental health, and compulsivity. Both of these activities have previously been shown to reduce stress and improve mental health, we are investigating whether one is more effective than the other.
As regular exercise and stress management training are time consuming, taking part in the study will reduce the opportunity to engage in compulsive behaviours. As such, our primary focus for the study will not be a reduction in the time spent engaging in compulsive behaviour. Instead, we will focus on whether the interventions modulate aspects of brain function associated with compulsivity (e.g. hippocampal integrity, functional brain activity during reward processing), aspects of cognition associated with compulsivity (e.g. affective processing bias and decision making), indices of the bodies stress system (e.g. cortisol awakening response), and aspects of mental health and quality of life that can be compromised in sub-clinical compulsive populations (e.g. experiential avoidance, general well being, symptoms of anxiety and depression).
- Conditions
- Compulsive Behavior
- Being tested
- Physical Exercise, Stress management training A, Stress management training B
- Medical subject headings
- Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseBehavioural
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.
Stress management training ABehavioural
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.
Stress management training BBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise + stress management activity A | Active comparator | Eight week program of concurrent exercise and stress management training. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hippocampal integrity
Composite score of hippocampal health indices, including volume (structural MRI) and neuronal NAA levels (MRS).
Measured: Baseline (0 months), post (2 months)
Secondary outcomes (7)
Change in functional activation during reward processing
fMRI Monetary Incentive Delay Task
Measured: Baseline (0 months), post (2 months)
Change in cortisol awakening reponse
Salivary cortisol
Measured: Baseline (0 months), post (2 months), follow up (three months)
Change in affective processing bias
BeanFest
Measured: Baseline (0 months), post (2 months), follow up (three months)
Change in risky decision making
Balloon Analogue Risk Task
Measured: Baseline (0 months), post (2 months), follow up (three months)
Change in behavioral compulsivity
Transdiagnositc YBOCS
Measured: Baseline (0 months), post (2 months), follow up (three months)
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.
Measured: Baseline (0 months), post (2 months), follow up (three months)
Change in physical fitness
VO2 max
Measured: Baseline (0 months), post (2 months), follow up (three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Segrave, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067636
- Sponsor's protocol ID
- 20160437
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retraining the Body and Brain to Conquer Compulsions
- ClinicalTrials.gov ID
- NCT03067636
- Acronym / sponsor ID
- 20160437
- Conditions
- Compulsive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- regular physical exercise + stress management activity A,
- regular physical exercise + stress management activity B,
- 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
Detailed description
This study is investigating the impact of regular physical exercise and stress management activities on mental health and brain function. It is specifically focusing on how engaging in these activities might impact activity in brain circuits associated with compulsivity, and help to reduce compulsive patterns of behaviour.
A compulsive behaviour is something that we do regularly, feel pressured to do, and have difficulty stopping even though it is not benefiting us. Having compulsive patterns of behaviour is very common. It's been estimated that as many as 80% of the general population experience compulsivity at some point in their lives. That's most of us! Compulsive behaviours range in severity from mild to entrenched, and can take many forms. For example, gambling too often or washing ones hands excessively. For some people what starts out as a mild pattern of behaviour, such as a glass of wine every night after a stressful day, can develop into a problem, like alcohol dependence. As so many people experience mild to moderate compulsivity it would be helpful to have accessible evidence-based strategies that reduce compulsive tendencies.
One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health and mental well being. Other candidates are specific stress management activities. Certain stress management techniques, such as brain training, meditation, psycho-education, music therapy, yoga, and guided relaxation, can promote optimal mental health, improve cognitive functioning and help keep the body's physiological arousal systems within a healthy range. Some stress management activities may also help to reduce compulsive behavioural patterns. Importantly, as physical exercise increases neuroplasticity (i.e. malleability of the brain), engaging in regular exercise may enhance the effectiveness of concurrent stress management activities.
This research study is investigating the impact of eight-weeks of regular physical exercise paired with two different stress management activities on brain health, mental health, and compulsivity. Both of these activities have previously been shown to reduce stress and improve mental health, we are investigating whether one is more effective than the other.
As regular exercise and stress management training are time consuming, taking part in the study will reduce the opportunity to engage in compulsive behaviours. As such, our primary focus for the study will not be a reduction in the time spent engaging in compulsive behaviour. Instead, we will focus on whether the interventions modulate aspects of brain function associated with compulsivity (e.g. hippocampal integrity, functional brain activity during reward processing), aspects of cognition associated with compulsivity (e.g. affective processing bias and decision making), indices of the bodies stress system (e.g. cortisol awakening response), and aspects of mental health and quality of life that can be compromised in sub-clinical compulsive populations (e.g. experiential avoidance, general well being, symptoms of anxiety and depression).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical exercise + stress management activity A | Active comparator | Behavioral: Physical Exercise, Behavioral: Stress management training AEight week program of concurrent exercise and stress management training. |
| Physical exercise + stress management activity B | Active comparator | Behavioral: Physical Exercise, Behavioral: Stress management training BEight week program of concurrent exercise and stress management training. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExercisePhysical 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. | Behavioural | Physical exercise + stress management activity A, Physical exercise + stress management activity B |
| Stress management training AStress 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. | Behavioural | Physical exercise + stress management activity A |
| Stress management training BStress 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. | Behavioural | Physical exercise + stress management activity B |
Primary outcome
Change in hippocampal integrity
Time frame: Baseline (0 months), post (2 months)
Composite score of hippocampal health indices, including volume (structural MRI) and neuronal NAA levels (MRS).
7 secondary outcomes
Change in functional activation during reward processing
Time frame: Baseline (0 months), post (2 months)
Change in cortisol awakening reponse
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in affective processing bias
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in risky decision making
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in behavioral compulsivity
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in psychosocial well being
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in physical fitness
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise, Stress management training A and Stress management training B in people with Compulsive Behavior, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hippocampal integrity (time frame: Baseline (0 months), post (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.