Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity
- Conditions
- ObesityMood Disorders
- Registration Number
- NCT03743844
- Lead Sponsor
- University of Western Ontario, Canada
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility of recruitment from community-based clinic 7-months (from baseline to 6-month follow-up) Proportion of eligible participants who agree to participate in the study
Adherence to the 6-week intervention 6 weeks (from baseline to end of treatment) Proportion of sessions attended, and minutes spent weekly on home practice exercises
- Secondary Outcome Measures
Name Time Method Changes in internalized weight bias 7 months (from baseline to 6-month follow-up) Weight Bias Internalization Scale (measures internalization of weight bias; mean score calculated, and ranges from 1 to 7)
Changes in physical activity engagement 7 months (from baseline to 6-month follow-up) International Physical Activity Questionnaire (measures physical activity frequency and intensity; continuous score of MET \[Metabolic Equivalent Task\] minutes per week)
Changes in depressive symptoms 7 months (from baseline to 6-month follow-up) Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)
Future adherence to weight management program 7 months (from baseline to 6-month follow-up) Attending follow-up appointments
Trial Locations
- Locations (1)
Western University
🇨🇦London, Ontario, Canada
Western University🇨🇦London, Ontario, Canada