Clinical trial NCT03743844: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Mood Disorders
Keywords: weight management
compassion-focused treatment
internalized weight bias
depressive symptoms
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Wharton Medical Clinic
name: Women's College Hospital
First posted: 2018-11-16
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of recruitment from community-based clinic
timeFrame: 7-months (from baseline to 6-month follow-up)
measure: Adherence to the 6-week intervention
timeFrame: 6 weeks (from baseline to end of treatment)
Secondary outcomes:
measure: Changes in internalized weight bias
timeFrame: 7 months (from baseline to 6-month follow-up)
measure: Changes in depressive symptoms
timeFrame: 7 months (from baseline to 6-month follow-up)
measure: Changes in physical activity engagement
timeFrame: 7 months (from baseline to 6-month follow-up)
measure: Future adherence to weight management program
timeFrame: 7 months (from baseline to 6-month follow-up)
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References: