Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

NCT03743844 | Completed

• 1 other identifier: 2018-0075-E
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Mood Disorders

Keywords

weight management; compassion-focused treatment; internalized weight bias; depressive symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in internalized weight bias

  7 months (from baseline to 6-month follow-up)

• Changes in depressive symptoms

  7 months (from baseline to 6-month follow-up)

• Changes in physical activity engagement

  7 months (from baseline to 6-month follow-up)

• Future adherence to weight management program

  7 months (from baseline to 6-month follow-up)

Study Arms (2)

Compassion-focused psychoeducation group

EXPERIMENTAL

Receiving 2-hours of group-based in-person psychoeducational sessions weekly for 6-weeks.

Behavioral: Compassion-focused psychoeducation group

Control group

NO INTERVENTION

Weight management treatment as usual

Interventions

Compassion-focused psychoeducation group BEHAVIORAL

Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises

Compassion-focused psychoeducation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Centre for Addiction and Mental Health: collaborator
• Wharton Medical Clinic: collaborator
• Women's College Hospital: collaborator

Study Sites (1)

Western University

London, Ontario, N6G 1G9, Canada

Location

MeSH Terms

Conditions

Obesity; Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 16, 2018
• Study Start: October 22, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2021
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)