- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02106728
Multi-Family Group Therapy for Adult Eating Disorders (MFGT)
A Comparison of Family Supportive Counseling and Multi-Family Therapy Group for People With Eating Disorders and Their Family Members: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 quality of life, and intense feelings of self-blame and shame as a result of their caregiving role. Caregivers often feel responsible for causing a loved one to develop the illness, and these feelings are often reinforced by professionals. In fact, the general public is more likely to blame families for causing BN compared with other mental illnesses such as schizophrenia. Poor family functioning in families of individuals with BN is predicted by problematic eating symptoms, conflict about how best to support the affected person, stigma and lack of social support. Concerns and fears that their loved one will be discriminated against or labeled negatively have been shown to result in family members withdrawing from their own social support network. Social support has been shown to mitigate caregiver distress and burden and poor health in carers of individuals with mental illnesses. Hence, an intervention is required to increase social support for individuals and their family members while providing educational information that challenges stigma, self-blame and shame.
Caring for an adult with chronic BN creates many challenges for the carer, including psychological duress, social isolation, stigma and poor family functioning. In turn, increased family conflict may exacerbate illness behaviours in the person with BN. Due to the emaciated appearance of the person with BN and the life threatening nature of this illness, family members may become overly protective and avoid discussions that may be distressing to the affected individual. Anxiety and depression may further heighten caregiver distress and intensify their propensity to over-protect the affected individual. Family members may also respond to severe symptoms by accommodating to the illness while taking on responsibility for the affected person in ways that are not age-appropriate. Negative feelings may be increased in the carers when their efforts to assist and motivate the person into treatment are met with denial about the seriousness of the illness and ambivalence to engage in treatment. These responses may elicit criticism from carers, especially if they perceive the eating symptoms as volitional. Emotional over-involvement, accommodation and criticism can have negative influences on the person with BN including heightened distress, decreased willingness to seek help and poorer treatment outcomes. An intervention is urgently needed to address the burden that this illness imposes on families and improve the quality of life of the carer, while teaching communication and problem solving skills that facilitate recovery from BN.
In the last decade, Multi-family group therapy (MFT) has been recognized internationally as an innovative approach to working with families of BN adolescents and has been shown to contribute to positive outcomes. MFT has also been widely employed and shown to be effective in families of adults affected with other mental illnesses including substance abuse, bipolar disorder and schizophrenia. To date, MFT has not been investigated in families of adults with BN. Given the evidence that demonstrates the efficacy of MFT in adolescent BN and other mental illnesses in adults, the proposed research study seeks to assess the efficacy of MFT for adults with BN and their families.
Overview of Proposed Study: In this study, the investigators propose to investigate MFT, which has never before been studied in adults with BN and their carers. The overarching objective will be to conduct a randomized controlled trial comparing MFT with treatment as usual (TAU) in patients receiving intensive treatment for BN and their carers.
Hypotheses and Research Questions: This proposed randomized controlled trial aims to provide pilot data regarding the efficacy of Multi-Family Therapy (MFT) in improving treatment outcomes for patients with Bulimia Nervosa (BN) and in reducing caregiver distress. Compared with patients not participating in MFT, the investigators hypothesize that patients with BN and their carers participating in MFT will have: 1) lower drop out rates, 2) higher likelihood of sustaining a body mass index (BMI) of 18.5 or higher at three months post-treatment, 3) greater improvement in general psychological health for carers from pre-treatment to three months post-treatment, and 4) reductions in the adverse impact of caregiving, expressed emotion and accommodation of eating behaviours at three months post-treatment. Finally, the investigators expect that descriptive data will show that MFT is a feasible, acceptable option for patients with BN and their carers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
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Toronto, Ontario, Canada, M5G2C4
- University Health Network, Toronto General Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any patient attending the eating disorders program at University Health Network, Toronto General Hospital and their family members over the age of 16 (siblings, parents, partners).
Exclusion Criteria:
- current family violence.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multi-Family Therapy
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
|
Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session.
Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders.
Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Active Comparator: Supportive Family Therapy
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist.
This is treatment as usual in the Eating Disorders Program at University Health Network.
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Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session.
The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dropout
Time Frame: 3 months post enrollment
|
3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
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3 months post enrollment
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Change in Weight
Time Frame: Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)
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Change in weight is measured to gauge if there has been a loss, gain, or maintenance.
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Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gina Dimitropoulos, PhD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1012-AE (UHN REB ID NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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