Social Therapy for Eating Disorders

(SF Trial)

Overseen By Ava Ryan

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Inpatient treatment, Medical instability, others

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

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how social therapy can assist individuals with eating disorders by focusing on mood and anxiety improvement. It compares two types of social therapy: one involves learning about social interactions, while the other includes a group art activity. The aim is to determine whether learning alone suffices or if the interactive component provides additional benefits. Individuals diagnosed with an eating disorder or anxiety in the past year and seeking new therapy options may find this trial suitable. As an unphased trial, it presents a unique opportunity to explore innovative therapy options that could enhance well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these social therapeutic interventions are safe for patients with eating disorders?

Past studies have shown that social therapy methods for eating disorders are safe. Research indicates that these therapies, whether focused on learning or interaction, are generally well-received by participants. Specifically, educational therapy has not been associated with any serious side effects and typically enhances social skills. Interactive therapy, which includes a group art activity, is also considered safe. Studies on similar low-intensity psychological treatments have demonstrated high satisfaction and completion rates, with a noticeable reduction in symptoms and no major safety issues. Overall, both methods seem to be safe options for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about social therapeutic interventions for eating disorders because they focus on enhancing social interactions and support, which is a fresh approach compared to traditional treatments like cognitive-behavioral therapy and medication. Unlike standard treatments that often concentrate on individual coping mechanisms, these interventions aim to harness the power of group dynamics and peer support to foster recovery. The educational arm emphasizes learning within a supportive community, while the interactive arm encourages active participation and engagement, offering a more dynamic and collaborative path to healing. This innovative angle could potentially improve treatment outcomes by addressing the social dimensions of eating disorders, which are often overlooked.

What evidence suggests that this trial's social therapeutic interventions could be effective for eating disorders?

This trial will compare two approaches: the Educational Social Therapeutic Intervention and the Interactive Social Therapeutic Intervention. Studies have shown that certain therapies can help treat eating disorders. For the Educational Social Therapeutic Intervention, research indicates that these therapies can improve symptoms, body image, and social well-being. The Interactive Social Therapeutic Intervention, another arm of this trial, offers similar benefits, focusing on improving social skills through group activities. Participants in these therapies often achieve better results than those who do not receive treatment or are on waitlists. While both interventions aim to enhance social understanding and thinking, the interactive approach may provide extra benefits by involving patients in group tasks. ^{2 4 6 7 8}

Who Is on the Research Team?

Carrie J McAdams, MD PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with eating disorders such as Anorexia Nervosa, Atypical Anorexia Nervosa, Bulimia Nervosa, Purging Disorder, or subthreshold Bulimia within the last year. It's not suitable for those who don't meet these specific criteria.

Inclusion Criteria

I have been diagnosed with an eating disorder like Anorexia or Bulimia in the last year.

Exclusion Criteria

Medical instability or safety/suicide risk as determined by the PI

I am currently staying in a hospital or treatment center.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks

1 day

1 visit (in-person)

Pre-intervention Assessment

Participants complete a pre-intervention assessment with questionnaires

1 day

Virtual

Treatment

Participants attend eight sessions of their assigned treatment group over the course of 12 weeks

12 weeks

8 sessions (in-person or virtual depending on group)

Follow-up

Participants complete three virtual follow-up assessments 4, 8, and 12 months from their baseline

12 months

3 visits (virtual)

Final Study Visit

Participants attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Social Therapeutic Interventions

Trial Overview The study is testing two types of social therapeutic interventions to see which helps more with eating disorders. One group will receive educational sessions about social functions in eating disorders while another will also participate in a collaborative art task.

How Is the Trial Designed?

Group I: Interactive Experimental Treatment 1 Intervention

Group II: Educational Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

A study involving 113 clinicians revealed that they have significant concerns about delivering certain elements of cognitive-behavioral therapy (CBT) for eating disorders, particularly regarding body image work and ending treatment.

Clinicians' experience levels influenced their concerns, with older and more experienced therapists feeling less anxious about delivering CBT techniques, while those with higher anxiety about uncertainty were more worried about specific aspects of the therapy, suggesting a need for targeted training in managing these anxieties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' concerns about delivering cognitive-behavioural therapy for eating disorders. Turner, H., Tatham, M., Lant, M., et al.[2022]

Eating disorder prevention programs can significantly improve knowledge about eating disorders and have a small but positive impact on reducing unhealthy eating attitudes and behaviors, according to a meta-analysis of various studies.

Programs aimed at individuals at higher risk for developing eating disorders showed greater effectiveness, and concerns about negative side effects from psychoeducational content were not supported by the data, suggesting these programs can be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorder prevention research: a meta-analysis. Cororve Fingeret, M., Warren, CS., Cepeda-Benito, A., et al.[2022]

Recent evidence supports the effectiveness of family-based treatment for adolescents with anorexia nervosa (AN) and cognitive behavior therapy (CBT) as a first-line therapy for bulimia nervosa (BN), based on a review of 36 new randomized controlled trials (RCTs).

While the risk of bias was low to moderate in most studies, further research is needed to explore the best treatment approaches for binge eating disorder (BED) and obesity, particularly through noninferiority trials of active therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of evidence for psychological treatments in eating disorders: 2005-2012. Hay, P.[2022]

The Psychological Outcome Profiles (PSYCHLOPS) is a validated individualized patient-reported outcome measure that effectively captures unique concerns of patients with eating disorders, showing adequate to good psychometric properties in a study of 278 emerging adults over 12 months.

More than half of the participants (53.3%) reported concerns not covered by standard eating disorder measures, such as depression, anxiety, and academic issues, highlighting the importance of personalized assessments in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of individualised patient-reported outcome measures in eating disorders: Validation of the Psychological Outcome Profiles. Austin, A., Potterton, R., Flynn, M., et al.[2021]

A single-day workshop involving 169 adult outpatients with eating disorders significantly increased their motivation to engage in care, with many patients moving from contemplation to action regarding their treatment (p < 0.001).

The improvement in motivation was closely linked to enhanced insight into their condition, indicating that experiential exposure to various psychotherapeutic approaches can effectively support patients in recognizing their need for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiencing eight psychotherapy approaches devoted to eating disorders in a single-day workshop increases insight and motivation to engage in care: a pilot study. Scanferla, E., Pachoud, B., Gorwood, P.[2022]

In a study of 1153 patients with various eating disorders, high levels of interpersonal distrust at the start of treatment were linked to a lower likelihood of achieving significant improvements in eating disorder symptoms.

Conversely, patients who had higher self-esteem and lower body dissatisfaction at baseline were more likely to experience a substantial reduction in symptoms, suggesting that addressing these psychological factors could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of psychological outcome in patients with eating disorders: A routine outcome monitoring study. Dingemans, AE., van Son, GE., Aardoom, JJ., et al.[2019]

Group psychotherapy is significantly more effective than wait-list controls for adults with eating disorders, showing higher rates of abstinence from binge eating and purging, and reducing related psychological symptoms, based on a meta-analysis of 27 randomized controlled trials with 1,853 participants.

The effectiveness of group psychotherapy is comparable to other active treatments, such as individual psychotherapy and behavioral weight loss, suggesting it is a viable and potentially more cost-effective option for treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group psychotherapy for eating disorders: A meta-analysis. Grenon, R., Schwartze, D., Hammond, N., et al.[2022]

In a study of 210 patients in an intensive outpatient program for eating disorders, rapid response (RR) was identified as the strongest predictor of improvement in eating disorder symptoms, accounting for 45.6% of the variance in outcomes post-treatment.

Baseline eating disorder pathology was the most significant predictor of overall functioning at the end of treatment, explaining 15.89% of the variance, highlighting the importance of initial symptom severity in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid response is predictive of treatment outcomes in a transdiagnostic intensive outpatient eating disorder sample: a replication of prior research in a real-world setting. Walker, DC., Donahue, JM., Heiss, S., et al.[2022]

A ten-session cognitive behavioural therapy (CBT-T) for transdiagnostic eating disorders showed significant improvements in eating disorder cognitions, behaviors, quality of life, and negative affect among 52 patients treated by trainee psychologists, with medium to large effect sizes observed from baseline to post-treatment and at follow-ups.

The study indicates that CBT-T can effectively address barriers to treatment, such as cost and access, with a comparable attrition rate of 38.5% to other treatment studies, suggesting it is a viable option for patients with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic effectiveness study of 10-session cognitive behavioural therapy (CBT-T) for eating disorders: Targeting barriers to treatment provision. Pellizzer, ML., Waller, G., Wade, TD.[2020]

In a randomized clinical trial with 133 females suffering from eating disorders, those receiving feedback interventions (Fb) showed a higher rate of clinically significant improvement (52.95%) compared to those receiving treatment-as-usual (TAU) (28.6%).

Patients in the Fb condition also demonstrated larger improvements in mental health functioning, although the effect size was smaller than in previous studies, indicating that feedback can be beneficial in inpatient settings for eating-disordered patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of providing patient progress feedback and clinical support tools to psychotherapists in an inpatient eating disorders treatment program: a randomized controlled study. Simon, W., Lambert, MJ., Busath, G., et al.[2015]

Out of 573 clinicians screened in Alberta, only 130 (22.7%) treated eating disorders, and among those, 118 were interviewed, revealing a diverse range of psychological interventions used.

The most common approach was eclectic therapy (43.2%), with cognitive-behavior therapy (CBT) being used by 22.9% of clinicians, but many self-reported CBT practitioners did not frequently apply specific CBT techniques, indicating a gap between practice and evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapies provided for eating disorders by community clinicians: infrequent use of evidence-based treatment. von Ranson, KM., Wallace, LM., Stevenson, A.[2018]

Single-session interventions (SSIs) are proposed as a promising solution to bridge the treatment gap for eating disorders, potentially helping individuals access care more easily and effectively with just one encounter.

Research suggests that SSIs may effectively reduce symptoms and risk factors associated with eating disorders, such as restrictive eating and negative body image, highlighting their potential as both standalone and adjunctive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realizing the untapped promise of single-session interventions for eating disorders. Schleider, JL., Smith, AC., Ahuvia, I.[2023]

Implementing cognitive behavioral therapy-enhanced (CBT-E) in a Dutch treatment center for eating disorders resulted in similar clinical outcomes compared to traditional treatment-as-usual (TAU), but with significantly lower treatment costs and shorter duration.

The study found a 71% likelihood that CBT-E is more cost-effective than TAU, indicating that evidence-based treatments can provide similar benefits while being more efficient in terms of resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing cognitive behavioral therapy-enhanced in a routine inpatient and outpatient setting: Comparing effectiveness and treatment costs in two consecutive cohorts. van den Berg, E., Schlochtermeier, D., Koenders, J., et al.[2020]

The Self-Blame and Perspective-Taking Intervention (SBPI) is a 4-week group therapy program that combines art therapy and psychoeducation, which helped participants develop self-acceptance and improve their social interactions related to eating disorders.

Participants reported positive experiences and valued the combination of psychosocial education and group activities, suggesting that addressing mental wellness aspects can be beneficial in treating eating disorders by helping patients separate their identity from the illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative patient experiences from the Self-Blame and Perspective-Taking Intervention for eating disorders. Hagan, WS., Mericle, S., Hunt, BJ., et al.[2021]

Citations

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Effectiveness of psychosocial interventions in eating disorders The main outcomes were: symptomatic remission, body image, cognitive distortion, psychiatric comorbidity, psychosocial functioning and patient satisfaction. The ...

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Targeting Social Function in Anxiety and Eating Disorders ... The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in ...

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Social Therapy for Eating Disorders (SF Trial) The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763422003463

Treatment of eating disorders: A systematic meta-review ... Family interventions were the most effective in anorexia nervosa, proving also beneficial in adolescents with bulimia nervosa.

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A Narrative Review of Early Intervention for Eating Disorders The aim of this review is to synthesize the literature on barriers to and facilitators of early intervention for EDs, regarding patient-, clinician-, service-, ...

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Social support for young people with eating disorders—An ... This integrative review sought to explore the positive outcomes of social support or social support programs for young people with eating disorders.