Eating DisordersMFGTNCT02106728
Multi-Family Group Therapy for Adult Eating Disorders
A study testing Multi-Family Therapy and Supportive Family Therapy in people with Eating Disorders, run by Gina Dimitropoulos at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Multi-Family Therapy and Supportive Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- current family violence.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G2C4
About this study
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
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.
Read the 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.
- Conditions
- Eating Disorders
- Being tested
- Multi-Family Therapy, Supportive Family Therapy
- Keywords
- Eating Disorders, Family Therapy, Multi-Family Therapy, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Family TherapyBehavioural
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.
Supportive Family TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supportive Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout
3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
Measured: 3 months post enrollment
Change in Weight
Change in weight is measured to gauge if there has been a loss, gain, or maintenance.
Measured: Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)
Secondary outcomes (1)
Change in Caregiver Functioning
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
Measured: Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gina Dimitropoulos
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor-investigator, Gina Dimitropoulos, University Health Network, Toronto
- Investigators
- Gina Dimitropoulos, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106728
- Sponsor's protocol ID
- 10-1012-AE (UHN REB ID NUMBER)
- Acronym
- MFGT
- Status last verified
- Jul 2016
- First submitted
- 1 Apr 2014
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02106728
- Acronym / sponsor ID
- MFGT / 10-1012-AE (UHN REB ID NUMBER)
- Conditions
- Eating Disorders
- Keywords
- Eating Disorders, Family Therapy, Multi-Family Therapy, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Gina DimitropoulosUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 13 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Family Therapy | Experimental | Behavioral: Multi-Family TherapyMulti-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions. |
| Supportive Family Therapy | Active comparator | Behavioral: Supportive Family TherapyFamily 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- current family violence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Family TherapyMulti-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. | Behavioural | Multi-Family Therapy |
| Supportive Family TherapySupportive 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. | Behavioural | Supportive Family Therapy |
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.
1 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Dimitropoulos, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Family Therapy and Supportive Family Therapy in people with Eating Disorders, run by Gina Dimitropoulos at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout (time frame: 3 months post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.