NCT02106728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 13, 2016

Completed
Last Updated

August 29, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

April 1, 2014

Results QC Date

December 23, 2015

Last Update Submit

July 25, 2016

Conditions

Keywords

Eating DisordersFamily TherapyMulti-Family TherapyBulimia NervosaEating Disorder Not Otherwise Specified

Outcome Measures

Primary Outcomes (2)

  • Dropout

    3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)

    3 months post enrollment

  • Change in Weight

    Change in weight is measured to gauge if there has been a loss, gain, or maintenance.

    Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)

Secondary Outcomes (1)

  • Change in Caregiver Functioning

    Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment

Study Arms (2)

Multi-Family Therapy

EXPERIMENTAL

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.

Behavioral: Multi-Family Therapy

Supportive Family Therapy

ACTIVE COMPARATOR

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.

Behavioral: Supportive Family Therapy

Interventions

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.

Multi-Family Therapy

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.

Supportive Family Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • current family violence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia Nervosa

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Lacked random assignment to MFT or SFT. Sample size of pilot was small and subsample of individuals were smaller in SFT than MFT. We may not have had statistical power to determine all differences in MFT and SFT groups. Sample not generalized.

Results Point of Contact

Title
Dr. Gina Dimitropoulos
Organization
Toronto General Hospital

Study Officials

  • Gina Dimitropoulos, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinician Scientist and Family Therapy Leader (PhD, MSW, LMFT)

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 8, 2014

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 29, 2016

Results First Posted

July 13, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

There is no plan or REB approval to share the IPD data. IPD will be kept confidential and destroyed as per UHN data policy when the study is concluded.

Locations