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Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Primary Purpose

Obesity, Mood Disorders

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Compassion-focused psychoeducation group

About this trial

This is an interventional supportive care trial for Obesity focused on measuring weight management, compassion-focused treatment, internalized weight bias, depressive symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Compassion-focused psychoeducation group

Control group

Arm Description

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

Weight management treatment as usual

Outcomes

Primary Outcome Measures

Feasibility of recruitment from community-based clinic

Proportion of eligible participants who agree to participate in the study

Adherence to the 6-week intervention

Proportion of sessions attended, and minutes spent weekly on home practice exercises

Secondary Outcome Measures

Changes in internalized weight bias

Weight Bias Internalization Scale (measures internalization of weight bias; mean score calculated, and ranges from 1 to 7)

Changes in depressive symptoms

Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)

Changes in physical activity engagement

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 program

Attending follow-up appointments

Full Information

NCT ID

NCT03743844

First Posted

October 29, 2018

Last Updated

May 31, 2023

Sponsor

University of Western Ontario, Canada

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03743844

Brief Title

Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

March 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Western Ontario, Canada

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Mood Disorders

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Compassion-focused psychoeducation group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Weight management treatment as usual

Intervention Type

Behavioral

Intervention Name(s)

Compassion-focused psychoeducation group

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of recruitment from community-based clinic

Description

Proportion of eligible participants who agree to participate in the study

Time Frame

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

Title

Adherence to the 6-week intervention

Description

Proportion of sessions attended, and minutes spent weekly on home practice exercises

Time Frame

6 weeks (from baseline to end of treatment)

Secondary Outcome Measure Information:

Title

Changes in internalized weight bias

Description

Weight Bias Internalization Scale (measures internalization of weight bias; mean score calculated, and ranges from 1 to 7)

Time Frame

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

Title

Changes in depressive symptoms

Description

Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)

Time Frame

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

Title

Changes in physical activity engagement

Description

International Physical Activity Questionnaire (measures physical activity frequency and intensity; continuous score of MET [Metabolic Equivalent Task] minutes per week)

Time Frame

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

Title

Future adherence to weight management program

Description

Attending follow-up appointments

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Western University

City

London

State/Province

Ontario

ZIP/Postal Code

N6G 1G9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

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