Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

May 31, 2023 updated by: Dr. Eva Pila, University of Western Ontario, Canada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 1G9
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment from community-based clinic
Time Frame: 7-months (from baseline to 6-month follow-up)
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
Time Frame: 6 weeks (from baseline to end of treatment)
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
Time Frame: 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)
7 months (from baseline to 6-month follow-up)
Changes in depressive symptoms
Time Frame: 7 months (from baseline to 6-month follow-up)
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
Time Frame: 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)
7 months (from baseline to 6-month follow-up)
Future adherence to weight management program
Time Frame: 7 months (from baseline to 6-month follow-up)
Attending follow-up appointments
7 months (from baseline to 6-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Collaborators

Centre for Addiction and Mental Health
Women's College Hospital
Wharton Medical Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2021

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0075-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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