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Completed

NCT Number: NCT03743844

Psychosocial 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western University

London, Ontario, N6G 1G9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compassion-focused psychoeducation group

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Future adherence to weight management program

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

    Attending follow-up appointments

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 16, 2018
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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