CClinicalTrials.gg
CompletedNCT03743844Updated Jun 2, 2023

Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

An interventional study of Compassion-focused psychoeducation group in Obesity and Mood Disorders, sponsored by University of Western Ontario, Canada. Completed at 1 site in Canada. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by University of Western Ontario, Canada · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Obesity
  • Mood Disorders

Keywords

  • weight management
  • compassion-focused treatment
  • internalized weight bias
  • depressive symptoms
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 47 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Western Ontario, Canada is the lead sponsor of 42 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Compassion-focused psychoeducation group

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

    Behavioral: Compassion-focused psychoeducation group

  • No intervention
    Control group

    Weight management treatment as usual

Interventions

  • BehavioralCompassion-focused psychoeducation group

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

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What researchers measure

Primary outcomes

  1. Feasibility of recruitment from community-based clinic

    Proportion of eligible participants who agree to participate in the study

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

  2. Adherence to the 6-week intervention

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

    Time frame: 6 weeks (from baseline to end of treatment)

Secondary outcomes

  1. Changes in internalized weight bias

    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)

  2. Changes in depressive symptoms

    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)

  3. 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)

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

  4. Future adherence to weight management program

    Attending follow-up appointments

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

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Study locations

1 site
  • Western University
    London, Ontario N6G 1G9, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03743844
Lead sponsor
University of Western Ontario, Canada
Collaborators
Centre for Addiction and Mental Health, Wharton Medical Clinic, Women's College Hospital
Responsible party
Dr. Eva Pila (Assistant Professor, University of Western Ontario, Canada) — Principal investigator
First posted
Nov 16, 2018
Start date
Oct 22, 2018
Primary completion
Mar 13, 2020
Completion
Mar 13, 2021
Last update
Jun 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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