Skip to content

Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743844
Enrollment
47
Registered
2018-11-16
Start date
2018-10-22
Completion date
2021-03-13
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood Disorders, Obesity

Keywords

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

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.

Interventions

BEHAVIORALCompassion-focused psychoeducation group

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of recruitment from community-based clinic7-months (from baseline to 6-month follow-up)Proportion of eligible participants who agree to participate in the study
Adherence to the 6-week intervention6 weeks (from baseline to end of treatment)Proportion of sessions attended, and minutes spent weekly on home practice exercises

Secondary

MeasureTime frameDescription
Changes in internalized weight bias7 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 depressive symptoms7 months (from baseline to 6-month follow-up)Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)
Changes in physical activity engagement7 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)
Future adherence to weight management program7 months (from baseline to 6-month follow-up)Attending follow-up appointments

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026