Home-Based Eating Disorder Therapies for Anorexia Nervosa

Recruiting at 2 trial locations

Overseen by Andrea B Goldschmidt, Ph.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Hospitalization, Drug dependence, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two types of home-based family therapy for teenagers with anorexia nervosa. It aims to see if involving families in therapy can help improve eating habits and emotional well-being. The study will measure how effective, acceptable, and practical these treatments are. Family-based treatment (FBT) has demonstrated efficacy for anorexia nervosa (AN) in youth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychotropic medication, you must be on a stable dose to participate.

What data supports the effectiveness of the treatment Home-Based Eating Disorder Therapies for Anorexia Nervosa?

Research shows that family-based treatment (FBT) is effective for adolescents with anorexia nervosa, with studies indicating its potential even when adapted for home use or delivered by non-specialists. Although not all patients achieve remission, FBT remains a first-line treatment, suggesting its overall effectiveness in managing anorexia nervosa. ^{1 2 3 4 5}

Is home-based family therapy for anorexia nervosa safe for humans?

Family-based treatment (FBT) for anorexia nervosa has been studied in adolescents and is generally considered safe, with no major safety concerns reported in the research. It involves parents taking an active role in helping their child regain weight and manage eating behaviors. ^{2 3 5 6 7}

How is the home-based family therapy treatment for anorexia nervosa different from other treatments?

Home-based family therapy for anorexia nervosa is unique because it involves the family in the treatment process, with parents taking an active role in helping their child regain weight, unlike traditional treatments that focus on individual autonomy. This approach can be delivered at home, making it more accessible and potentially more effective for families who cannot access standard outpatient care. ^{2 3 4 5 8}

Research Team

Andrea B Goldschmidt, Ph.D.

Principal Investigator

The University of Pittsburgh

Eligibility Criteria

This trial is for adolescents with anorexia or atypical anorexia who are medically stable enough to be treated outside of a hospital, living at home with caregivers willing to participate in treatment, and not currently using other psychological treatments for eating disorders. They must also have a steady dose if they're on psychotropic medication.

Inclusion Criteria

Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.

I live at home with caregivers ready to participate in my treatment.

I am stable on my mental health medication and meet all other trial requirements.

Exclusion Criteria

A participant has a condition that makes it difficult for them to take part in the study due to developmental delays.

Concurrent involvement in other psychological treatment for an eating disorder.

I have a physical illness that requires me to be hospitalized.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

10-32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• Family-based treatment (FBT) (Behavioral Intervention)
• Integrative family therapy (Behavioral Intervention)

Trial Overview The study compares two types of therapy delivered at home: Family-based treatment (FBT) and Integrative family therapy. It aims to see which is more effective when given in the patient's own environment by assessing weight changes, eating behaviors, and how well families can apply what they learn.

Participant Groups

Group I: Family-based treatment Experimental Treatment 1 Intervention

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Group II: Integrative family therapy Active Control 1 Intervention

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Rhode Island College

Collaborator

Trials

2

Recruited

60+

Lifespan

Collaborator

Trials

43

Recruited

41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study of 409 adolescents with anorexia nervosa (AN) undergoing family-based treatment (FBT), key symptoms like desiring weight loss and dietary restraint were found to predict early treatment response, specifically weight gain by the fourth session.

Parental beliefs about their role in their child's recovery were identified as important factors influencing end-of-treatment outcomes, suggesting that enhancing parental self-efficacy could improve weight restoration and overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding outcomes in family-based treatment for adolescent anorexia nervosa: a network approach. Hagan, KE., Matheson, BE., Datta, N., et al.[2023]

A parental guided self-help version of family-based treatment (FBT) for adolescent anorexia nervosa was found to be feasible and acceptable, with 19 families participating in the study over 6 months.

Participants showed significant improvements in weight, with median BMI increasing from 85.01% to 97.31%, and reductions in eating-related psychopathology, indicating potential effectiveness of this self-help approach, although further evaluation is needed due to a high dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental guided self-help family based treatment for adolescents with anorexia nervosa: A feasibility study. Lock, J., Darcy, A., Fitzpatrick, KK., et al.[2018]

Family-based treatment (FBT) is effective for younger children with anorexia nervosa, as shown by a study of 32 children with a mean age of 11.9 years, who experienced significant weight gain and improved eating disorder symptoms after treatment.

Children with anorexia nervosa exhibit similar disordered eating behaviors to adolescents, but their symptoms are less severe, indicating that FBT can be tailored effectively for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is family therapy useful for treating children with anorexia nervosa? Results of a case series. Lock, J., le Grange, D., Forsberg, S., et al.[2019]

A brief intervention using five FBT-inspired therapy sessions, called 'DREAMS', showed positive outcomes for seven adolescents with mild eating disorders, including improved food intake, reduced eating disorder symptoms, and enhanced mood.

All families involved reported that the DREAMS sessions were beneficial, suggesting that modified family-based treatment could be a promising early intervention for adolescents with mild or subsyndromal eating disorders, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Modified Family-Based Treatment Intervention for Youth With Mild Eating Disorders: A Case Series. Spettigue, W., Aldaqqaq, Z., Isserlin, L., et al.[2022]

Family-based treatment (FBT) for anorexia nervosa (AN) was successfully implemented with 20 adolescents aged 12-17, showing a high retention rate of 75% and significant improvements in weight restoration and menstrual status.

The treatment led to notable reductions in eating restraint and eating concerns, indicating its effectiveness in addressing key symptoms of AN, while some areas like shape and weight concerns did not show significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open trial of family-based treatment for full and partial anorexia nervosa in adolescence: evidence of successful dissemination. Loeb, KL., Walsh, BT., Lock, J., et al.[2019]

In a study of 59 adolescents with anorexia nervosa, adherence to key components of family-based treatment (FBT) such as parental control and unity significantly predicted greater weight gain during treatment.

The therapeutic alliance was positively linked to weight gain when mothers were involved, but negatively when fathers were involved, indicating the importance of the parent-child relationship in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do the components of manualized family-based treatment for anorexia nervosa predict weight gain? Ellison, R., Rhodes, P., Madden, S., et al.[2022]

Family-based treatment (FBT) is becoming a preferred method for treating adolescent anorexia nervosa (AN) and bulimia nervosa (BN), showing promising outcomes in clinical studies.

The review discusses the suitability of FBT for various adolescent groups and family dynamics, suggesting that while FBT is effective, its application may need to be tailored for older adolescents and those with comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatment for Adolescent Eating Disorders: Current Status, New Applications and Future Directions. Loeb, KL., le Grange, D.[2022]

This randomized clinical trial will assess the efficacy of family-based treatment with home treatment (FBT-HT) compared to standard outpatient family-based treatment (FBT) and FBT with mindfulness-based stress reduction (FBT-MBSR) in 90 adolescents with anorexia nervosa, aiming to improve weight and eating habits.

The study will also evaluate the feasibility and acceptability of FBT-HT, with the hypothesis that it will outperform both standard FBT and FBT-MBSR, while also addressing caregiver stress and family dynamics as factors influencing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. Besse-Flütsch, N., Bühlmann, C., Fabijani, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Understanding outcomes in family-based treatment for adolescent anorexia nervosa: a network approach. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Parental guided self-help family based treatment for adolescents with anorexia nervosa: A feasibility study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Is family therapy useful for treating children with anorexia nervosa? Results of a case series. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Brief Modified Family-Based Treatment Intervention for Youth With Mild Eating Disorders: A Case Series. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Open trial of family-based treatment for full and partial anorexia nervosa in adolescence: evidence of successful dissemination. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Do the components of manualized family-based treatment for anorexia nervosa predict weight gain? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Family-Based Treatment for Adolescent Eating Disorders: Current Status, New Applications and Future Directions. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. [2023]