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Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

U

University of Western Ontario, Canada

Status

Completed

Conditions

Obesity
Mood Disorders

Treatments

Behavioral: Compassion-focused psychoeducation group

Study type

Interventional

Funder types

Other

Identifiers

NCT03743844
2018-0075-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Compassion-focused psychoeducation group
Experimental group
Description:
Receiving 2-hours of group-based in-person psychoeducational sessions weekly for 6-weeks.
Treatment:
Behavioral: Compassion-focused psychoeducation group
Control group
No Intervention group
Description:
Weight management treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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