Home-Based Eating Disorder Therapies for Anorexia Nervosa

No longer recruiting at 2 trial locations

Overseen By Dayna Winograd, B.S.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Hospitalization, Drug dependence, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10-32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test two types of therapy for adolescents with anorexia nervosa, a serious eating disorder. The goal is to evaluate the effectiveness of these therapies when conducted at home, making treatment more accessible. Participants will receive either family-based treatment (FBT) or integrative family therapy, with each involving 2-6 hours of therapy per week. Adolescents diagnosed with anorexia nervosa or related disorders who live at home with supportive caregivers are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment accessibility for others in the future.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that family-based treatment (FBT) for anorexia nervosa is generally safe and well-tolerated. Studies have found positive results, particularly in reducing symptoms of the eating disorder. For instance, one study found that 80% of patients reached a healthy weight within 16 weeks, indicating the treatment's effectiveness and manageability (https://www.mdpi.com/2673-5318/5/2/15).

In integrative family therapy, involving families in the treatment process adds value and helps create a safe therapy environment. This approach is recognized as helpful for treating adolescent anorexia nervosa, with positive feedback from both patients and families about its effectiveness and safety (https://pmc.ncbi.nlm.nih.gov/articles/PMC8246805/).

Both therapies emphasize family support, which is crucial in safely managing anorexia nervosa. No significant reports of negative side effects have emerged, suggesting these treatments are safe options for adolescents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these home-based therapies for anorexia nervosa because they offer a flexible and accessible approach compared to traditional in-patient treatments. Family-based treatment (FBT) and integrative family therapy allow families to participate actively in the recovery process within their own homes, which can reduce the stress and stigma associated with clinical settings. This method is unique because it tailors the therapy duration based on clinical needs and insurance coverage, potentially making it more personalized and cost-effective. By integrating family support into the treatment process, these therapies aim to create a more supportive environment for individuals, which could lead to better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for anorexia nervosa?

Research has shown that family-based treatment (FBT), one of the treatments studied in this trial, is highly effective for teenagers with anorexia nervosa. In studies, most patients experienced positive outcomes, with body weight returning to normal and a decrease in eating disorder symptoms. Approximately 80% of patients reached a healthy weight within 16 weeks. FBT is often the preferred treatment for anorexia in teenagers.

Integrative family therapy, another treatment option in this trial, also shows promise. It improves eating disorder symptoms and supports weight gain when necessary. Although it has not been studied as extensively as FBT, involving families in the treatment adds value. Overall, both treatments have demonstrated positive results for managing anorexia in teenagers. ^{1 5 6 7 8}

Who Is on the Research Team?

Andrea B Goldschmidt, Ph.D.

Principal Investigator

The University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8820974/

Understanding outcomes in family-based treatment for ... Family-based treatment (FBT) is the first-line treatment for adolescent anorexia nervosa (AN). Yet, remission is not achieved for about half of adolescents ...

2. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00879-9

Effects of family-based treatment on adolescent outpatients ... At the end of treatment, most patients had a good outcome, including normalization of their body weight and reduced ED symptoms. The majority of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6764593/

Family-based Treatment of Eating Disorders FAMILY-BASED TREATMENT OF ANOREXIA NERVOSA​​ The primary outcome variable in this study was full remission, defined as reaching greater than or equal to 95% of ...

4. mdpi.com mdpi.com/2673-5318/5/2/15

Modifications to Enhance Outcomes of Family-Based ... Eighty percent achieved weight remission by 16 weeks of V-FBT+ and significant changes in both weight and eating disorder cognition/behavior.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1077722923000172

Enhanced Family-Based Treatment for an Adolescent With ... FBT is the treatment of choice for adolescents with anorexia and bulimia nervosa, and preliminary data suggest it is effective for ARFID. Among the many ...

6. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00496-4

“I'm still here, but no one hears you”: a qualitative study of ... Family Based treatment (FBT) [9] has been reported to have positive treatment outcomes, particularly on eating disorder (ED) symptomatology, ...

7. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/210890

Randomized Clinical Trial Comparing Family-Based ... Family-based treatment was significantly superior for partial remission at EOT but not at follow-up. In addition, body mass index percentile at ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1389652/full

Adaptations to family-based treatment for Medicaid-insured ... Family-based treatment (FBT) is the leading intervention for adolescents with anorexia nervosa (AN); however, it is under researched in socioeconomically ...