Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Study Overview
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Brief Summary
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Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Strategies are needed to support the psychological well-being of this population, and improve adherence to weight-related treatment. The goal of this preliminary study is to determine the acceptability of a group-based compassion-focused psychoeducational intervention among women with mood disorders who are attending a behavioral weight management program.

Detailed Description
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Pilot feasibility trial to examine the acceptability and efficacy of compassion-based intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood symptoms), and improving weight management outcomes (i.e., physical activity behaviour, dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight management. In this proof of concept study, adult females with a diagnosis of major depressive disorder of bipolar disorder will be randomized into two arms: weight management treatment as usual + psychoeducation group; weight management as usual + control.

Official Title
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Compassion-focused Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Conditions
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Obesity, Mood Disorders

Intervention / Treatment
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* Behavioral: Compassion-focused psychoeducation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English. Female participants 18 - 65 years of age, inclusive, at the time of screening. Available and able to attend weekly group meeting on assigned dates. Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI. Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment. Weight status of at least 25kg/m2, as indicated by data from last appointment at WMC. Access to a computer and email account in order to complete online questionnaires Exclusion Criteria: Enrolled in surgical management of obesity at WMC. Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis. Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassion-focused psychoeducation group<br>Receiving 2-hours of group-based in-person psychoeducational sessions weekly for 6-weeks. | Behavioral: Compassion-focused psychoeducation group<br>* Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises<br>|
| No Intervention: Control group<br>Weight management treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment from community-based clinic | Proportion of eligible participants who agree to participate in the study | 7-months (from baseline to 6-month follow-up) | 
| Adherence to the 6-week intervention | Proportion of sessions attended, and minutes spent weekly on home practice exercises | 6 weeks (from baseline to end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in internalized weight bias | Weight Bias Internalization Scale (measures internalization of weight bias; mean score calculated, and ranges from 1 to 7) | 7 months (from baseline to 6-month follow-up) | 
| Changes in depressive symptoms | Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63) | 7 months (from baseline to 6-month follow-up) | 
| Changes in physical activity engagement | International Physical Activity Questionnaire (measures physical activity frequency and intensity; continuous score of MET [Metabolic Equivalent Task] minutes per week) | 7 months (from baseline to 6-month follow-up) | 
| Future adherence to weight management program | Attending follow-up appointments | 7 months (from baseline to 6-month follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight management, compassion-focused treatment, internalized weight bias, depressive symptoms