Teletherapy Treatments for Anorexia Nervosa

Overseen By Ann Haynos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Medical instability, Pregnancy, Psychotic, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two teletherapy treatments to support individuals recovering from anorexia nervosa. Participants will receive either Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) after leaving a higher-level care facility. The trial aims to determine which approach better aids recovery by improving weight and reducing symptoms of eating disorders, depression, and anxiety. It suits those who have recently completed intensive eating disorder treatment and are transitioning to outpatient care. Participants should have access to a smartphone or computer for remote therapy sessions.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research in teletherapy treatments for eating disorders.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you can participate in most other forms of outpatient treatment while receiving the research intervention.

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

A previous study found the Positive Affect Treatment for Anorexia Nervosa (PAT-AN) to be safe. Participants generally adhered to the treatment, which received high satisfaction ratings, scoring between 5.67 and 5.95 out of 7. This indicates that most participants found the treatment acceptable.

Earlier research showed that Psychoeducational and Behavioral Therapy (PBT) is generally well-tolerated by people with anorexia nervosa. Studies reported that 63% to 100% of participants completed the therapy, suggesting that most individuals can continue with it. This indicates that PBT is generally safe and accepted by participants.

Past research has shown both treatments to be well-tolerated and safe, making them good options for individuals considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these teletherapy treatments for anorexia nervosa because they offer innovative approaches that differ from traditional methods like inpatient care and cognitive-behavioral therapy. The Positive Affect Treatment for Anorexia Nervosa (PAT-AN) is unique because it focuses on enhancing positive emotions, which could provide a refreshing angle by promoting emotional well-being alongside physical recovery. Meanwhile, Psychoeducational and Behavioral Therapy (PBT) offers structured guidance and behavior-focused strategies that patients can easily access from home, potentially increasing adherence and reducing barriers to care. These new methods could transform how patients engage with treatment, making it more accessible and potentially more effective.

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

This trial will compare two treatments for anorexia nervosa: Positive Affect Treatment for Anorexia Nervosa (PAT-AN) and Psychoeducational and Behavioral Therapy (PBT). Research has shown that PAT-AN is promising. In earlier studies, participants who received PAT-AN improved their body mass index (BMI) and experienced fewer eating disorder symptoms. This treatment targets the brain's reward system, potentially boosting mood and improving eating habits.

PBT, another treatment option in this trial, has reduced eating disorder behaviors in some cases. However, it hasn't consistently outperformed standard treatments for anorexia nervosa in adults. Both treatments hold potential, but PAT-AN might offer more specific benefits for mood and reward-related issues. ^{1 2 5 6 7}

Who Is on the Research Team?

Ann Haynos, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Anorexia Nervosa who are transitioning from intensive treatment to outpatient care or have done so within the last 3 months. They must be willing to participate in weekly assessments, speak English, and have access to a smartphone or computer. Those with medical instability, overlapping therapy content, pregnancy, substance use disorders, or primary psychotic/bipolar-I disorder cannot join.

Inclusion Criteria

I am willing to do weekly check-ins and allow my therapy sessions to be recorded.

Current BMI > or = 18.5 kg/m2 (or will be by time of discharge)

I was recently discharged from a higher-level care facility to outpatient care.

Exclusion Criteria

Current DSM-5 substance use disorder

Enrollment in outpatient therapy with highly overlapping content to PAT-AN

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy for 24 weeks

24 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Positive Affect Treatment for Anorexia Nervosa (PAT-AN)
• Psychoeducational and Behavioral Therapy (PBT)

Trial Overview The study compares two remote therapies for Anorexia Nervosa after intensive treatment: Positive Affect Treatment (PAT-AN) and Psychoeducational and Behavioral Therapy (PBT). Participants will receive one of these treatments via teletherapy for 24 weeks starting within three months post-discharge.

How Is the Trial Designed?

Group I: Positive Affect Treatment for Anorexia Nervosa (PAT-AN): Experimental Treatment 1 Intervention

Group II: Psychoeducational and Behavioral Therapy (PBT): Active Control 1 Intervention

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

Psychedelic-assisted therapy (PAT) shows promise as a safe and potentially effective treatment for eating disorders, particularly anorexia nervosa, although the exact efficacy is still being established through early clinical trials.

Current research indicates that classic psychedelics may work through various mechanisms that are relevant to the pathology of eating disorders, but high-quality data supporting their use in this context is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychedelic-Assisted Therapy for People with Eating Disorders. Gukasyan, N., Schreyer, CC., Griffiths, RR., et al.[2023]

Adolescents with anorexia nervosa whose parents attended a parent education and skills workshop during the first 4 weeks of family-based treatment showed greater weight gain by Week 4 compared to those whose parents did not attend, indicating the workshop's positive impact on early treatment response.

While the workshop improved early weight gain and parent knowledge and confidence, it did not lead to significant differences in weight at Week 12 or end of treatment, suggesting its benefits may be more immediate rather than long-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a parent education and skills workshop for improving response to family-based treatment of adolescent anorexia nervosa. Ganci, M., Pradel, M., Hughes, EK.[2018]

In a study of 107 adolescents with anorexia nervosa, parent-focused treatment (PFT) showed a significantly higher remission rate at the end of treatment (43%) compared to family-based treatment (FBT) (22%), suggesting that involving only parents may be more effective initially.

However, at 6 and 12 months post-treatment, the differences in remission rates between PFT and FBT were not statistically significant, indicating that while PFT may lead to quicker results, both treatments may ultimately have similar long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Parent-Focused Treatment and Family-Based Treatment for Adolescent Anorexia Nervosa. Le Grange, D., Hughes, EK., Court, A., et al.[2022]

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 involving 242 adults with anorexia nervosa, both focal psychodynamic therapy and enhanced cognitive behavior therapy led to weight gain after 10 months, but there were no significant differences in BMI increases between the treatment groups.

Optimized treatment as usual, which included psychotherapy and structured care, was found to be a solid baseline treatment, while enhanced cognitive behavior therapy showed faster weight gain and improvements in eating disorder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial. Zipfel, S., Wild, B., Groß, G., et al.[2022]

Family-Based Treatment for Transition Age Youth (FBT-TAY) is a feasible and acceptable intervention for treating Anorexia Nervosa, as shown by a pilot study with 26 participants, where only 27.27% opted for standard treatment instead.

Participants experienced significant improvements in eating disorder behaviors and achieved weight restoration by the end of treatment and maintained these gains at a three-month follow-up, indicating the potential effectiveness of FBT-TAY.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Trial of Family-Based Treatment of Anorexia Nervosa for Transition Age Youth. Dimitropoulos, G., Landers, AL., Freeman, V., et al.[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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37811810/

A randomized, controlled pilot study of positive affect treatment ... The PAT-AN group showed medium to large pre-to-post-treatment improvements in BMI, eating disorder symptoms and impairment, depressive and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04007900

Positive Affect Treatment (PAT) to Target Reward ... The goal of the proposed research is to determine the extent to which Positive Affect Treatment (PAT), a novel treatment targeting reward mechanisms, can ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001784/

A Randomized, Controlled Pilot Study of Positive Affect ... PAT-AN holds promise as an innovative treatment with capability to simultaneously improve eating disorder symptoms, affective symptoms, and underlying reward ...

4. psycnet.apa.org psycnet.apa.org/record/2024-18210-001

A randomized, controlled pilot study of positive affect ... PAT-AN holds promise as an innovative treatment with capability to simultaneously improve eating disorder symptoms, affective symptoms, and underlying reward ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05799872

Study Details | NCT05799872 | Neuroscience-informed ... At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also ...

6. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00417-5

Adapting a neuroscience-informed intervention to alter reward ... Positive Affect Treatment (PAT) is a cognitive-behavioral intervention designed to target reward deficits that contribute to anhedonia in mood and anxiety ...

7. researchgate.net researchgate.net/publication/374637462_A_randomized_controlled_pilot_study_of_positive_affect_treatment_adapted_for_anorexia_nervosa

A randomized, controlled pilot study of positive affect ... Results PAT‐AN demonstrated strong retention (100%) and acceptability ratings (M = 5.67–5.95 on a 7‐point scale). BMI (p = .006) and eating disorder symptoms (p ...