CompletedNot Applicable

Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Canada47 participantsStarted 2018-10-22

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of recruitment from community-based clinic

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

Adherence to the 6-week intervention

Timeframe: 6 weeks (from baseline to end of treatment)

Trial details

NCT IDNCT03743844

SponsorUniversity of Western Ontario, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-13

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