A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Eating Disorder Not Otherwise Specified

Treatments: Behavioral: End-of-Intervention Questionnaires (~5 minutes); Behavioral: SSI (Single-session intervention (~30 minutes) Active arm; Behavioral: Screening Questionnaire; Behavioral: SSI (Single-session intervention (~30 minutes) control arm; Behavioral: Pre-Intervention Questionnaires (~10 minutes)

Study type: Interventional

Funder types: Other

Identifiers

NCT06861608

HM20030734

FP00023118 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).

Full description

The emergence of EDs is bimodal such that there is a period of risk in early adolescence and a period of risk in late adolescence/early adulthood. EDs can lead to significant mental and physical health consequences and have one of the highest mortality rates of any mental illness. Prevention and treatment programs for EDs are fraught with barriers to access, particularly related to seeking care in-person. SSIs have been identified as a pathway to address the gap in care for EDs after showing promise for other psychiatric problems, including depression, anxiety, and suicidality .

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• EAT-26 score ≥ 20 ( EAT-26, participants will meet the "referral criteria" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative/diuretic use, and/or exercise.)
• English-language fluency, self-reported3
• Access to a phone, tablet, or computer

Exclusion criteria

• Failure to correctly complete one of the attention checks in the survey prior to the intervention
• Failure to correctly complete both anagram tasks in the survey prior to the intervention
• Completion of the screening survey or pre-intervention surveys in an improbably fast time

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups, including a placebo group

Experimental: psychoeducation experience single-session intervention (SSI)

Experimental group

Description:

This online randomized controlled trial of a habit training intervention includes one 30-minute session for young adults endorsing high levels of eating pathology. The intervention will occur at one timepoint.

Treatment:

Behavioral: Pre-Intervention Questionnaires (~10 minutes)

Behavioral: SSI (Single-session intervention (~30 minutes) Active arm

Behavioral: Screening Questionnaire

Behavioral: End-of-Intervention Questionnaires (~5 minutes)

Control: will be matched to the SSI by including both reading and writing exercises.

Placebo Comparator group

Description:

The control intervention will consist of supportive therapy focusing on sharing emotions and include an introduction to emotions, writing about emotions, testimonials from other adolescents about the power of sharing emotions, and an exercise asking adolescents how different situations might make them feel.

Treatment:

Behavioral: Pre-Intervention Questionnaires (~10 minutes)

Behavioral: SSI (Single-session intervention (~30 minutes) control arm

Behavioral: Screening Questionnaire

Behavioral: End-of-Intervention Questionnaires (~5 minutes)