What side effects are associated with this type of intervention?

Family-Based Treatment (FBT) and Integrated Family Therapy (IFT) are psychotherapeutic approaches that generally have fewer physical side effects compared to pharmacotherapy. However, they can lead to emotional and psychological challenges, such as increased family stress and conflict during the initial stages of treatment. Patients and families may experience frustration, anxiety, or resistance to the therapeutic process. Additionally, the intensive nature of these therapies can be time-consuming and emotionally draining for both patients and caregivers. It is important for clinicians to monitor these potential side effects and provide support to families throughout the treatment process.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of eating disorders, particularly for binge eating disorder and bulimia nervosa. For instance, fluoxetine (Prozac) is approved for bulimia nervosa. However, there are no specific FDA-approved medications for anorexia nervosa. Treatments like Family-Based Treatment and Integrated Family Therapy, which focus on enhancing caregiver involvement and combining family dynamics with individual therapy, are primarily psychotherapeutic approaches and do not involve FDA-approved drugs. These therapies aim to improve treatment outcomes by leveraging family support and addressing both individual and familial aspects of the disorder.

What other types of research exist?

Promising novel alternatives to Family-Based Treatment and Integrated Family Therapy for eating disorders include: 1) Cognitive-Behavioral Therapy (CBT), which has shown efficacy in addressing dysfunctional beliefs and behaviors related to anorexia nervosa, with a significant percentage of patients achieving a BMI >18.5 kg/m2. 2) Specialist Supportive Clinical Management, which combines supportive psychotherapy with clinical management to address core symptoms of anorexia nervosa. 3) Motivational Interviewing, which helps patients explore their ambivalence about change and motivates them to gain weight by discussing the impact of the illness on their lives and their personal goals.

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Behavioral Intervention

Home-Based Eating Disorder Therapies for Anorexia Nervosa

N/A

Recruiting

Led By Andrea B Goldschmidt, Ph.D.

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Associated physical illness that necessitates hospitalization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological treatments rather than medications, traditional side effects like you might see with drugs aren't expected. However, participants may experience emotional distress or discomfort as part of the therapeutic process.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body mass index percentile

Eating Disorder Examination

Secondary study objectives

Abbreviated Acceptability Rating Profile

Acceptability, Appropriateness, and Feasibility of Intervention Measure

Attendance

+7 more

Other study objectives

Child & Adolescent Symptom Inventory (CASI)

Child Depression Inventory (CDI)

Difficulties in Emotion Regulation Scale (DERS-18)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Family-based treatmentExperimental Treatment1 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 therapyActive Control1 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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Family-Based Treatment (FBT) enhances caregiver involvement and self-efficacy, empowering families to support patients in normalizing eating patterns and achieving a healthy weight. Integrated Family Therapy (IFT) combines family dynamics and individual therapy to address relational and personal factors contributing to the disorder, reducing adolescent distress and improving treatment outcomes. These approaches are crucial as they leverage the patient's support system, making treatment more holistic and potentially more effective.

Family in pediatric obesity management: a literature review.