Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

NCT ID: NCT03743844

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2021-03-13

Brief Summary

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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

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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.

Conditions

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Obesity Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Compassion-focused psychoeducation group

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

Group Type EXPERIMENTAL

Compassion-focused psychoeducation group

Intervention Type BEHAVIORAL

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

Control group

Weight management treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compassion-focused psychoeducation group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

Wharton Medical Clinic

UNKNOWN

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Dr. Eva Pila

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Western University

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2018-0075-E

Identifier Type: -

Identifier Source: org_study_id

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