Clinical Trial: Multi-Family Group Therapy for Adult Eating Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Comparison of Family Supportive Counseling and Multi-Family Therapy Group for People With Eating Disorders and Their Family Members: A Randomized Controlled Trial

Brief Summary: Eating Disorders are a debilitating and serious mental illness. This illness is associated with medical complications, psychological and social impairment. Families of people with an eating disorder also report that they lack resources and have many unmet needs. Families often have insufficient information regarding the eating disorder, available treatment options and strategies for supporting the person with the illness. The purpose of this study is to evaluate the effectiveness of two different family interventions for people with eating disorders and their family members (parents or partners) receiving treatment either in the inpatient or day treatment Eating Disorder Program at the Toronto General Hospital, University Health Network. Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. Multi-family group therapy involves eight to ten families who meet as a group with two therapists. The investigators are conducting a study to assess the differences between these two different family interventions. This study will help us identify who benefits the most from participating in family supportive counseling or multi-family therapy. The investigators are also evaluating which intervention is more effective at helping the person with the eating disorder overcome their illness while helping their family members learn how to support the recovery process. Both family therapy interventions are delivered by experienced family therapy clinicians who work in either the Inpatient or Day Treatment Eating Disorder Program at Toronto General Hospital.

Detailed Summary:

Background: Bulimia Nervosa (BN) is a serious and persistent mental illness with a high rate of mortality and morbidity. Research demonstrates that individuals with BN have high drop-out rates, multiple re-admissions to tertiary care programs and high relapse rates all of which may contribute to the chronicity of this illness. A systematic review of randomized controlled trials for eating disorders reveals dropout rates ranging from 0-43%. Individuals with BN are at the highest risk for relapse during the first three months following the completion of inpatient treatment for BN. A higher BMI at completion of an intensive eating disorder program and weight maintenance immediately following treatment are associated with lower relapse rates at six and twelve months. Women with chronic BN have a poorer quality of life than women in the general population in a variety of domains. Individuals with BN have access to a smaller support network outside of their nuclear family compared with normal controls. They are often confronted with negative stereotypes and stigmatizing attitudes from the general public who often perceive affected individuals as having control over their eating behaviours. Fear of being stigmatized and negatively stereotyped, a poor quality of life, a smaller social support network and lower expectations of receiving appropriate support, may contribute to and heighten the reliance of individuals with BN on their immediate families for emotional and instrumental support. The over-reliance on families for support may contribute to duress in families who may be willing to assist the person afflicted with BN but lack the sufficient knowledge and skills to effectively intervene to assist with the significant medical and psychological impairment that results from this illness.

Caregivers of individuals with eating disorders experience significant distress poor qualit
Sponsor: Gina Dimitropoulos

Current Primary Outcome:

  • Dropout [ Time Frame: 3 months post enrollment ]
    3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
  • Change in Weight [ Time Frame: Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy) ]
    Change in weight is measured to gauge if there has been a loss, gain, or maintenance.


Original Primary Outcome:

  • Dropout [ Time Frame: 3 months post enrollment ]
    3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
  • Change in Weight [ Time Frame: Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), 3 months post treatment ]
    Change in weight is measured to gauge if there has been a loss, gain, or maintenance.


Current Secondary Outcome: Change in Caregiver Functioning [ Time Frame: Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment ]

EDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer's families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression


Original Secondary Outcome: Change in Caregiver Functioning [ Time Frame: Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), , three months post-treatment ]

Caregivers are given questionnaires to assess burden, stress, depression, and eating disorder knowledge at three time-points.


Information By: University Health Network, Toronto

Dates:
Date Received: April 1, 2014
Date Started: January 2012
Date Completion:
Last Updated: July 25, 2016
Last Verified: July 2016