Teletherapy Treatments for Anorexia Nervosa

Overseen by Ann Haynos, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Commonwealth University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.

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 teletherapy treatment for anorexia nervosa safe for humans?

Research on psychedelic-assisted therapy (PAT) suggests it may be safe for various mental health conditions, including eating disorders like anorexia nervosa. ^{1 2 3 4 5}

How is the PAT-AN treatment different from other treatments for anorexia nervosa?

PAT-AN is unique because it focuses on enhancing positive emotions and behaviors through teletherapy, which can be more accessible and convenient compared to traditional in-person therapies. This approach is different from other treatments like family-based therapy, which involves the family in the treatment process, or cognitive behavior therapy, which focuses on changing negative thought patterns. ^{1 4 6 7 8}

Research Team

Ann Haynos, PhD

Principal Investigator

Principal Investigator

Eligibility Criteria

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.

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

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

Exclusion Criteria

Current DSM-5 substance use disorder

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

Pregnancy

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 (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 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]

References

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

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

2. Canada pubmed.ncbi.nlm.nih.gov

Open Trial of Family-Based Treatment of Anorexia Nervosa for Transition Age Youth. [2022]

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

Psychedelic-Assisted Therapy for People with Eating Disorders. [2023]

4. 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]

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

Feasibility of a parent education and skills workshop for improving response to family-based treatment of adolescent anorexia nervosa. [2018]

6. England 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. [2022]

7. 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]

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

Randomized Clinical Trial of Parent-Focused Treatment and Family-Based Treatment for Adolescent Anorexia Nervosa. [2022]