Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743844
• Other study ID #: 2018-0075-E
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: March 13, 2021

Study information

• Verified date: May 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 13, 2021
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Obesity

Intervention

Behavioral:
• Compassion-focused psychoeducation group
Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Centre for Addiction and Mental Health, Wharton Medical Clinic, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Future adherence to weight management program	Attending follow-up appointments	7 months (from baseline to 6-month follow-up)