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Is Health Coaching Effective for Improving Metabolic Health in People With Psychosis Disorders?

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01752465
First received: December 14, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Psychotic Disorders
Metabolic Syndrome x
Behavioral: Health Coaching
Behavioral: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Is Health Coaching a Useful Clinical Tool to Facilitate Healthy Lifestyle Change and Improve Metabolic Health in People With Psychotic Illness?

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Scores on the Short-Form 36 [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Waist circumference [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Blood Pressure [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Heart Rate [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Fasting plasma glucose [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Fasting total cholesterol [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Fasting cholesterol subfractions [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Fasting triglycerides [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.

  • Fasting insulin [ Time Frame: Baseline, month 1, month 2, month 3, and month 6 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
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.
Behavioral: Health Coaching
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.
Other Names:
  • Integrative Health Coaching
  • EPI Metabolic Group
Behavioral: Standard care
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.
Experimental: Health Coaching
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.
Behavioral: Health Coaching
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.
Other Names:
  • Integrative Health Coaching
  • EPI Metabolic Group

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752465

Locations
Canada, British Columbia
Vancouver/Richmond Early Psychosis Intervention Clinic
Vancouver, British Columbia, Canada, V5K 1Z9
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Investigators
Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01752465     History of Changes
Other Study ID Numbers: H12-01896, F12-01992
Study First Received: December 14, 2012
Last Updated: January 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Health behaviour
Antipsychotic agents
Adverse effects
Goals
Life style

Additional relevant MeSH terms:
Disease
Mental Disorders
Metabolic Syndrome X
Psychotic Disorders
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014