Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Sponsor

University of Western Ontario, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT03743844

Collaborator

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

Enrollment

Location

Arms

16.7

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Mood Disorders	Behavioral: Compassion-focused psychoeducation group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 22, 2018

Actual Primary Completion Date :

Mar 13, 2020

Actual Study Completion Date :

Mar 13, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feasibility of recruitment from community-based clinic [7-months (from baseline to 6-month follow-up)]
Proportion of eligible participants who agree to participate in the study
Adherence to the 6-week intervention [6 weeks (from baseline to end of treatment)]
Proportion of sessions attended, and minutes spent weekly on home practice exercises

Secondary Outcome Measures

Changes in internalized weight bias [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)
Changes in depressive symptoms [7 months (from baseline to 6-month follow-up)]
Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)
Changes in physical activity engagement [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)
Future adherence to weight management program [7 months (from baseline to 6-month follow-up)]
Attending follow-up appointments

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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