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

Primary Purpose

Psychotic Disorders, Metabolic Syndrome x

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health Coaching
Standard care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychotic Disorders focused on measuring Health behaviour, Antipsychotic agents, Adverse effects, Goals, Life style

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver/Richmond Early Psychosis Intervention Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Health Coaching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 14, 2012
Last Updated
November 30, 2015
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01752465
Brief Title
Is Health Coaching Effective for Improving Metabolic Health in People With Psychosis Disorders?
Official Title
Is Health Coaching a Useful Clinical Tool to Facilitate Healthy Lifestyle Change and Improve Metabolic Health in People With Psychotic Illness?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Metabolic Syndrome x
Keywords
Health behaviour, Antipsychotic agents, Adverse effects, Goals, Life style

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health Coaching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching
Other Intervention Name(s)
Integrative Health Coaching, EPI Metabolic Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores on the Short-Form 36
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Scores on The Three Factor Eating Questionnaire (TFEQ)
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Scores on The Health Value Scale
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Secondary Outcome Measure Information:
Title
Waist circumference
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Blood Pressure
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Heart Rate
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Fasting plasma glucose
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Fasting total cholesterol
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Fasting cholesterol subfractions
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Fasting triglycerides
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6
Title
Fasting insulin
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, and month 6

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alasdair M Barr, Ph.D.
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver/Richmond Early Psychosis Intervention Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5K 1Z9
Country
Canada

12. IPD Sharing Statement

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

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