Psychotic DisordersNCT01752465
Is Health Coaching Effective for Improving Metabolic Health in People With Psychosis Disorders?
A study testing Health Coaching in people with Psychotic Disorders and Metabolic Syndrome x, run by University of British Columbia at 1 site in Canada.
Trial summary
Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity, high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular health problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychotic Disorders, Metabolic Syndrome x
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have a primary working diagnosis of schizophrenia/schizoaffective disorder, or bipolar disorder, or psychosis not otherwise specified (PNOS)
- Subjects must be prescribed an atypical (or 'second-generation') antipsychotic drug
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver/Richmond Early Psychosis Intervention Clinic
Vancouver, British Columbia, V5K 1Z9
About this study
Official title: Is Health Coaching a Useful Clinical Tool to Facilitate Healthy Lifestyle Change and Improve Metabolic Health in People With Psychotic Illness?
Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity, high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular health problems. Therefore, it is important that metabolic issues be addressed as part of a holistic approach to the mental health treatment of these patients.
As with the general population, improving metabolic health involves lifestyle changes - i.e., addressing daily habits regarding eating, physical exercise, stress and sleep management, and lifestyle habits such as smoking. However, there is growing recognition in the medical field that education is not enough for people to create meaningful and sustained lifestyle change. The emerging field of Integrative Health Coaching addresses this issue and provides a clinical framework for helping people successfully develop and achieve personalized lifestyle goals. The investigators have therefore decided to investigate whether health coaching techniques may have benefit in addressing metabolic health issues in people with psychosis disorders. The intent is to complement usual psychiatric and medical care, and also promote patient engagement in managing one's overall health.
This study will investigate whether Integrative Health Coaching is a useful clinical tool to facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with psychosis disorders.
Read the detailed description
Antipsychotic drugs are widely used to treat not only psychosis but an increasing number of other psychiatric indications. The prevalence of antipsychotic drug use in British Columbia is increasing at a high rate, especially in youth. Second generation ("atypical") antipsychotic drugs, while bereft of the neurological side-effects of their predecessors, commonly cause metabolic syndrome. This includes hyperglycemia, hyperlipidemia, insulin resistance, weight gain and hypertension - a cluster of side-effects that puts patients at strongly increased risk of cardiometabolic disorders such as Type 2 diabetes and cardiovascular disease. Drug therapies to reduce metabolic dysregulation have provided limited benefits. It is recognized that lifestyle changes that address daily habits regarding eating, physical exercise, stress and sleep management, and lifestyle habits such as smoking, represent a complementary approach to additional drug therapy. The emerging field of Integrative Health Coaching addresses this issue and provides a clinical framework for helping people successfully develop and achieve personalized lifestyle goals. This study will investigate whether Health Coaching is a useful clinical tool to facilitate healthy lifestyle behavior and thereby improve metabolic health in people with psychotic illness.
HYPOTHESIS: In a first-episode psychosis population that have recently begun treatment with atypical antipsychotic drugs, the inclusion of an Integrative Health Coaching goal-setting model will significantly improve patients' attitudes towards, and increase the frequency of behaviours related to healthy living, as indicated by the Short-Form 36, the Three-Factor Eating Questionnaire, and the Health Value Scale.
RESEARCH PLAN: The investigators will conduct a non-blinded clinical trial of the efficacy of Integrative Health Coaching techniques in 40 subjects who are being treated at the Vancouver/Richmond Early Psychosis Intervention program, which provides specialty care to patients with suspected or newly diagnosed psychotic disorders. All subjects will be randomly assigned to one of two treatment groups (n = 20 subjects per group). In the first group, subjects will receive treatment for psychosis based on the current standard of care, which includes psychosocial training, education and pharmacological treatment. The second group of subjects will receive not only the standard of care treatment for psychosis, but additional Health Coaching to improve physical health. Subjects in both treatment groups will be given questionnaires to assess health attitudes and behaviours, and will receive routine blood work to monitor metabolic dysregulation, at baseline and months 1, 2, 3 and 6 from when they enter the study. Data will be collected and analyzed for differences between the two groups at the end of the study. Results will be analyzed based on intent-to-treat analysis, and comparison of metabolic and other health indices compared between the two groups using t-test and chi-square analyses.
- Conditions
- Psychotic Disorders, Metabolic Syndrome x
- Being tested
- Health Coaching, Standard care
- Keywords
- Health behaviour, Antipsychotic agents, Adverse effects, Goals, Life style
- Medical subject headings
- Psychotic Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Also called Integrative Health Coaching, EPI Metabolic Group
Health Coaching sessions are 2 hours long. Participants individually receive a physical assessment, and recent blood work and medications are reviewed. When everyone has been assessed, the group reconvenes to watch a video about the importance of making healthy lifestyle choices, participates in a 10 min. fitness activity, and receives training on making SMART goals (SMART stands for specific, measurable, achievable, realistic, and timely). Each participant individually creates a SMART goal for him/herself, and this goal is reviewed as a group. Each participant rates the importance of this goal, and rates their level of confidence in succeeding. Progress is tracked in subsequent sessions, and metabolic health is continually monitored through routine blood work.
Standard careBehavioural
Standard clinical care will continue for all participants in the study, regardless of the study arm. This includes routine clinical visits to the attending psychiatrist, and receiving pharmacotherapy, standard patient education, and psychosocial training.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Patients in the standard care group will receive standard clinical care from their attending psychiatrist, including pharmacotherapy and education. Study assessments will be done at baseline, and once a month thereafter at Months 1, 2, 3, and 6. Receives: Behavioral: Health Coaching; Behavioral: Standard care |
| Health Coaching | Experimental | Patients in the Health Coaching group will receive both Health Coaching, and standard care. In addition to routine clinical appointments, patients receiving Health Coaching will attend Health Coaching sessions twice a month during Months 1, 2, and 3, and once a month during Months 4, 5, and 6. Study assessments will be conducted at baseline, and once a month thereafter during Health Coaching sessions at Months 1, 2, 3, and 6. Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Short-Form 36
Scores on the Short-Form 36 (a standardized, validated questionnaire measuring general health) will be compared between patients in the Health Coaching group versus patients receiving only standard care.
Measured: Baseline, month 1, month 2, month 3, and month 6
Scores on The Three Factor Eating Questionnaire (TFEQ)
Scores on the Three Factor Eating Questionnaire (a questionnaire measuring cognitive restraint of eating, disinhibition, and hunger) will be compared between patients in the Health Coaching group, versus patients receiving only standard care.
Measured: Baseline, month 1, month 2, month 3, and month 6
Scores on The Health Value Scale
Scores on the Health Value Scale (a questionnaire measuring value placed on health) will be compared between patients in the Health Coaching group, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Secondary outcomes (8)
Waist circumference
Change in waist circumference over 6 months, and comparison of the change in waist circumference between patients in the Health Coaching group, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Blood Pressure
Change in systolic and diastolic blood pressure over 6 months, and comparison of the change in systolic and diastolic blood pressure between patients receiving Health Coaching, and patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Heart Rate
Change in heart rate over 6 months, and comparison of the change in heart rate between patients receiving Health Coaching, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Fasting plasma glucose
Change in fasting plasma glucose over 6 months, and comparison of the change in fasting plasma glucose between patients in the Health Coaching group, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Fasting total cholesterol
Change in fasting total cholesterol over 6 months, and comparison of the change in fasting total cholesterol between patients in the Health Coaching group, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Fasting cholesterol subfractions
Change in fasting cholesterol subfractions (LDL-C, HDL-C) over 6 months, and comparison of the change in fasting cholesterol subfractions between patients receiving Health Coaching, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Fasting triglycerides
Change in fasting triglycerides over 6 months, and comparison of the change in fasting triglycerides between patients receiving Health Coaching, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Fasting insulin
Change in fasting insulin over 6 months, and comparison of the change in fasting insulin between patients receiving Health Coaching, versus patients receiving standard care only.
Measured: Baseline, month 1, month 2, month 3, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752465
- Sponsor's protocol ID
- H12-01896
- Other IDs
- F12-01992
- Status last verified
- Nov 2015
- First submitted
- 14 Dec 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Health Coaching a Useful Clinical Tool to Facilitate Healthy Lifestyle Change and Improve Metabolic Health in People With Psychotic Illness?
- ClinicalTrials.gov ID
- NCT01752465
- Acronym / sponsor ID
- H12-01896
- Conditions
- Psychotic Disorders, Metabolic Syndrome x
- Keywords
- Health behaviour, Antipsychotic agents, Adverse effects, Goals, Life style
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Dec 2012 (estimated)
- 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.
Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity, high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular health problems. Therefore, it is important that metabolic issues be addressed as part of a holistic approach to the mental health treatment of these patients.
As with the general population, improving metabolic health involves lifestyle changes - i.e., addressing daily habits regarding eating, physical exercise, stress and sleep management, and lifestyle habits such as smoking. However, there is growing recognition in the medical field that education is not enough for people to create meaningful and sustained lifestyle change. The emerging field of Integrative Health Coaching addresses this issue and provides a clinical framework for helping people successfully develop and achieve personalized lifestyle goals. The investigators have therefore decided to investigate whether health coaching techniques may have benefit in addressing metabolic health issues in people with psychosis disorders. The intent is to complement usual psychiatric and medical care, and also promote patient engagement in managing one's overall health.
This study will investigate whether Integrative Health Coaching is a useful clinical tool to facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with psychosis disorders.
Detailed description
Antipsychotic drugs are widely used to treat not only psychosis but an increasing number of other psychiatric indications. The prevalence of antipsychotic drug use in British Columbia is increasing at a high rate, especially in youth. Second generation ("atypical") antipsychotic drugs, while bereft of the neurological side-effects of their predecessors, commonly cause metabolic syndrome. This includes hyperglycemia, hyperlipidemia, insulin resistance, weight gain and hypertension - a cluster of side-effects that puts patients at strongly increased risk of cardiometabolic disorders such as Type 2 diabetes and cardiovascular disease. Drug therapies to reduce metabolic dysregulation have provided limited benefits. It is recognized that lifestyle changes that address daily habits regarding eating, physical exercise, stress and sleep management, and lifestyle habits such as smoking, represent a complementary approach to additional drug therapy. The emerging field of Integrative Health Coaching addresses this issue and provides a clinical framework for helping people successfully develop and achieve personalized lifestyle goals. This study will investigate whether Health Coaching is a useful clinical tool to facilitate healthy lifestyle behavior and thereby improve metabolic health in people with psychotic illness.
HYPOTHESIS: In a first-episode psychosis population that have recently begun treatment with atypical antipsychotic drugs, the inclusion of an Integrative Health Coaching goal-setting model will significantly improve patients' attitudes towards, and increase the frequency of behaviours related to healthy living, as indicated by the Short-Form 36, the Three-Factor Eating Questionnaire, and the Health Value Scale.
RESEARCH PLAN: The investigators will conduct a non-blinded clinical trial of the efficacy of Integrative Health Coaching techniques in 40 subjects who are being treated at the Vancouver/Richmond Early Psychosis Intervention program, which provides specialty care to patients with suspected or newly diagnosed psychotic disorders. All subjects will be randomly assigned to one of two treatment groups (n = 20 subjects per group). In the first group, subjects will receive treatment for psychosis based on the current standard of care, which includes psychosocial training, education and pharmacological treatment. The second group of subjects will receive not only the standard of care treatment for psychosis, but additional Health Coaching to improve physical health. Subjects in both treatment groups will be given questionnaires to assess health attitudes and behaviours, and will receive routine blood work to monitor metabolic dysregulation, at baseline and months 1, 2, 3 and 6 from when they enter the study. Data will be collected and analyzed for differences between the two groups at the end of the study. Results will be analyzed based on intent-to-treat analysis, and comparison of metabolic and other health indices compared between the two groups using t-test and chi-square analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Health Coaching, Behavioral: Standard carePatients in the standard care group will receive standard clinical care from their attending psychiatrist, including pharmacotherapy and education. Study assessments will be done at baseline, and once a month thereafter at Months 1, 2, 3, and 6. |
| Health Coaching | Experimental | Behavioral: Health CoachingPatients in the Health Coaching group will receive both Health Coaching, and standard care. In addition to routine clinical appointments, patients receiving Health Coaching will attend Health Coaching sessions twice a month during Months 1, 2, and 3, and once a month during Months 4, 5, and 6. Study assessments will be conducted at baseline, and once a month thereafter during Health Coaching sessions at Months 1, 2, 3, and 6. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have a primary working diagnosis of schizophrenia/schizoaffective disorder, or bipolar disorder, or psychosis not otherwise specified (PNOS)
- Subjects must be prescribed an atypical (or 'second-generation') antipsychotic drug
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Health CoachingAlso: Integrative Health Coaching, EPI Metabolic GroupHealth Coaching sessions are 2 hours long. Participants individually receive a physical assessment, and recent blood work and medications are reviewed. When everyone has been assessed, the group reconvenes to watch a video about the importance of making healthy lifestyle choices, participates in a 10 min. fitness activity, and receives training on making SMART goals (SMART stands for specific, measurable, achievable, realistic, and timely). Each participant individually creates a SMART goal for him/herself, and this goal is reviewed as a group. Each participant rates the importance of this goal, and rates their level of confidence in succeeding. Progress is tracked in subsequent sessions, and metabolic health is continually monitored through routine blood work. | Behavioural | Health Coaching, Standard Care |
| Standard careStandard clinical care will continue for all participants in the study, regardless of the study arm. This includes routine clinical visits to the attending psychiatrist, and receiving pharmacotherapy, standard patient education, and psychosocial training. | Behavioural | Standard Care |
Primary outcome
Scores on the Short-Form 36
Time frame: Baseline, month 1, month 2, month 3, and month 6
Scores on the Short-Form 36 (a standardized, validated questionnaire measuring general health) will be compared between patients in the Health Coaching group versus patients receiving only standard care.
Scores on The Three Factor Eating Questionnaire (TFEQ)
Time frame: Baseline, month 1, month 2, month 3, and month 6
Scores on the Three Factor Eating Questionnaire (a questionnaire measuring cognitive restraint of eating, disinhibition, and hunger) will be compared between patients in the Health Coaching group, versus patients receiving only standard care.
Scores on The Health Value Scale
Time frame: Baseline, month 1, month 2, month 3, and month 6
Scores on the Health Value Scale (a questionnaire measuring value placed on health) will be compared between patients in the Health Coaching group, versus patients receiving standard care only.
8 secondary outcomes
Waist circumference
Time frame: Baseline, month 1, month 2, month 3, and month 6
Blood Pressure
Time frame: Baseline, month 1, month 2, month 3, and month 6
Heart Rate
Time frame: Baseline, month 1, month 2, month 3, and month 6
Fasting plasma glucose
Time frame: Baseline, month 1, month 2, month 3, and month 6
Fasting total cholesterol
Time frame: Baseline, month 1, month 2, month 3, and month 6
Fasting cholesterol subfractions
Time frame: Baseline, month 1, month 2, month 3, and month 6
Fasting triglycerides
Time frame: Baseline, month 1, month 2, month 3, and month 6
Fasting insulin
Time frame: Baseline, month 1, month 2, month 3, and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Alasdair M Barr, Ph.D. principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Psychotic Disorders and Metabolic Syndrome x, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. 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 Canada. 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?
Results are not available in the source record.
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?
Scores on the Short-Form 36 (time frame: Baseline, month 1, month 2, month 3, and month 6). The study lists 3 primary outcomes in all. 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 2 Dec 2015.