Clinical trial NCT01752465: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorders
Metabolic Syndrome x
Keywords: Health behaviour
Antipsychotic agents
Adverse effects
Goals
Life style
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health Research Institute
First posted: 2012-12-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Scores on the Short-Form 36
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Scores on The Three Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Scores on The Health Value Scale
timeFrame: Baseline, month 1, month 2, month 3, and month 6
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Blood Pressure
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Heart Rate
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Fasting plasma glucose
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Fasting total cholesterol
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Fasting cholesterol subfractions
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Fasting triglycerides
timeFrame: Baseline, month 1, month 2, month 3, and month 6
measure: Fasting insulin
timeFrame: Baseline, month 1, month 2, month 3, and month 6
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver/Richmond Early Psychosis Intervention Clinic
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Alasdair M Barr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: