Clinical trial NCT06203418: Investigation of Multi-Family Therapy for Anorexia Nervosa
Official title: Investigation of Multi-Family Therapy for Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Multi-Family Therapy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2024-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed project is an intensive multi family therapy (MFT) intervention involving patients with anorexia nervosa and their families. MFT interventions are informed from the principles of the family based treatment (FBT)/family therapy for Anorexia Nervosa (FT-AN) models. This program will offer families in vivo/virtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times, including meal support and affect regulation. Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment, including weight, expressed emotion and eating disorder symptomatology.

Detailed description: The proposed project is an intensive multi family therapy (MFT) intervention involving patients with anorexia nervosa and their families. MFT interventions are informed from the principles of the family based treatment (FBT)/family therapy for Anorexia Nervosa (FT-AN) models. This program will offer families in vivo/virtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times, including meal support and affect regulation. Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment, including weight, expressed emotion and eating disorder symptomatology.

Families/patients will participate in an initial phone screen with the study coordinator to determine eligibility for the MFT. When participants are deemed eligible, they will then follow-up with a trained study assessor, where they will be consented for the study and complete both written and interview based assessments. Parents are welcome to participate without their child if their child does not wish to assent; the child may assent and participate in further treatment days if they wish. Families attending the group will continue to complete assessments throughout the study. Parents will complete the assessment interviews to their best knowledge about their child if their child does not choose to participate. Once a child agrees to participate, they will complete assessment interviews themselves. Patients will receive medical clearance/assessment by their primary care doctor or Eating Disorder medical provider prior to the start of the group. All medical assessments will be reviewed by Dr. Karen Bernstein. When "in person" group gatherings may resume, each treatment group will consist of 3-8 families with a new cohort starting approximately every 6 weeks (total of 6-8 sessions over a 1 year time period).

Accepted families will then by the 4 day MFT. Day 1 will involve a two hour orientation to the group. Families will learn the medical consequences of eating disorders, psychological principles of the treatment intervention, the expectations of participation, meet the treatment team, as well as hear from a family who has been through treatment. On the rest of day 1 through day 4, families will participate in a variety of planned activities aimed at facilitating change throughout the treatment process. Additionally, the "in person" group will have 3 3-6 hour follow up group sessions scheduled at 2 weeks post intervention (virtual), 1 month post intervention (in person), and 3 months post intervention (in person). In the virtual model, each treatment group will consist of 3-8 families with a new cohort starting approximately every 4-6 weeks (total of 8 -13 sessions over a 1 year time period). Day 1 will be a similar orientation as described above using the Zoom virtual platform. On the rest of day 1 and through day 4, families will participate in synchronous and asynchronous activities modified for the virtual format. Families in the virtual group will also participate in 3 3-hour follow up sessions in 2 weeks, 1 month, 3 months (all virtual).

Per the Multi-Family Therapy for Anorexia Nervosa Treatment Manual (Draft) (Simic M, Baudinet J et al), mechanisms of change in the group involve:

1. Multiple sources of input (parents, carers, young people, professionals) working together will allow participants to be both givers and receivers of new ideas/thoughts. Additionally, this will allow families to experiment with new behavioral interventions. The group is aimed at offering young people and their families the opportunity to experience simultaneous different roles. This process allows for new learning and experimentation with new ideas around the illness and family. Meeting families that are confronted with the same illness yet at different stages of recovery, makes experience sharing particularly rich and can inspire hope for change.
2. The MFT is designed purposefully with increased intensity and broadening of the treatment scope. Families receive a large dose of the treatment in the format of 4, 6 hour days (in person), or 4, 4 hour days with additional asynchronous tasks (virtual). The dose of treatment is created to match the intensity of the illness and promote behavioral experimentation and change within a short period of time. This 4 day "burst" has the primary aim of increasing parental efficacy in taking charge of the patient's illness. Families will participate in additional follow up sessions to "boost" and monitor the effects of the intervention
3. The MFT is designed to increase solidarity, reduce isolation, and facilitate building a community around behavioral change.

The overall themes of the intervention are engagement and understanding of the illness and its impact on the family, managing mealtimes and providing in vivo support during meals and process/problem solving around mealtimes, exploration of the impact of the illness of family relationships and working to set a path to improve them, and planning for the future (Simic M, Baudinet J et al). The intervention will include educational/cognitive behavioral, motivational, and problem-solving components, along with relational elements.

Eligibility criteria: Inclusion Criteria:

* English speaking
* living at home with at least one parent/guardian
* diagnosis of restricting eating disorder
* 11-18 years of age
* Medically stable per medical clearance form

Exclusion Criteria:

* Active psychosis (parent or child)
* Current dependence on drug or alcohol (parent or child)
* Past history/current abuse (sexual/physical), neglect

Primary outcomes:
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 1. weight
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 2. BMI
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 3. Heart rate
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 4. eating disorder thoughts and behaviors
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 5. co-morbid psychiatric disorders
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 6. co-morbid psychiatric disorders
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 7. co-morbid psychiatric disorders
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) 8. sleep quality
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 9. expressed emotion
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 10. expressed emotion
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 11. expressed emotion
timeFrame: 1 year
measure: Effect on Eating Disorder Symptomatology (multiple variables) - 12. Parenting styles
timeFrame: 1 year
Secondary outcomes:
measure: Implementation and feasibility of virtual adaptation of MFT 1. participant retention
timeFrame: 4 years
measure: Implementation and feasibility of virtual adaptation of MFT - 2. participant satisfaction
timeFrame: 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: