NCT06610318

Brief Summary

Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common. They are also associated with depression and disordered eating, predictors of early mortality. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling distressing memories, like NEREAs, and generating ideas for bringing support into these memories. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The current study examined the feasibility and acceptability of a remote-delivered, single session of IR in a community sample of men and women with NEREAs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 17, 2024

Last Update Submit

September 19, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • enrollment

    the total number of participants enrolled in the study and a demographic description of these participants, including their sex, gender, race, ethnicity, age and body mass index

    once, at baseline, over the duration of recruitment to obtain the sample size of interest

  • fidelity

    the % of intervention curriculum the interventionists cover during their intervention session as rated by research staff using a curriculum checklist

    during the intervention session only

  • data collection completeness

    % of missing data collected at all study visits

    baseline, intervention, 1-month, and 3-month

  • intervention acceptability

    captured via self-report survey items created by the researchers; participants were asked questions such as the extent to which they liked engaging in the intervention; response options are on a Likert-type scale ranging from strongly agree to strongly disagree; average scores at the item level will be generated by condition

    these data will be collected during the 1-month follow-up visit

  • safety

    frequency of adverse events

    these data will be collected during and between all study visits, from baseline though the 3-month follow-up visit

  • retention

    the % of participants retained at each visit relative to baseline (i.e., percentage of total enrolled who attended the intervention visit, the 1-month follow-up visit, and the 3-month follow-up visit)

    from baseline through the 3-month follow-up visit

Study Arms (2)

Imagery rescripting

EXPERIMENTAL

This condition has three stages. In the first stage, participants were asked to select their most distressing memory related to their appearance (not physical or sexual trauma). They were asked to visualize the selected memory, in detail, as if it were happening to them again. Then, interventionists used a downward arrow technique to identify two-to-three maladaptive core schema. In the second stage, participants were asked to identify a real or imagined trusted adult. Then, they were asked to imagine what their younger self might need to cope with or feel calmer in the situation of their selected memory. In the third stage, the participant was instructed to imagine asking the trusted adult for what they need and to imagine the trusted adult providing their selected interventions and describe how they feel afterwards. These procedures were then repeated with participants' most distressing memory related to eating. This session was remote delivered via Zoom.

Behavioral: imagery rescripting

Nutrition education control

ACTIVE COMPARATOR

The active control condition consisted of a time- and attention-matched general nutrition education session. The curriculum for this intervention included information from the United States Department of Agriculture's Dietary Guidelines (e.g., food labels, describing the benefits of macronutrients). This session was remote delivered using Zoom.

Behavioral: nutrition education

Interventions

This condition has three stages. In the first stage, participants were asked to select their most distressing memory related to their appearance (not physical or sexual trauma). They were asked to visualize the selected memory, in detail, as if it were happening to them again. Then, interventionists used a downward arrow technique to identify two-to-three maladaptive core schema. In the second stage, participants were asked to identify a real or imagined trusted adult. Then, they were asked to imagine what their younger self might need to cope with or feel calmer in the situation of their selected memory. In the third stage, the participant was instructed to imagine asking the trusted adult for what they need and to imagine the trusted adult providing their selected interventions and describe how they feel afterwards. These procedures were then repeated with participants' most distressing memory related to eating. This session was remote delivered via Zoom.

Imagery rescripting

The active control condition consisted of a time- and attention-matched general nutrition education session. The curriculum for this intervention included information from the United States Department of Agriculture's Dietary Guidelines (e.g., food labels, describing the benefits of macronutrients). This session was remote delivered using Zoom.

Nutrition education control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old
  • endorse a history of at least one negative experience related to eating and/or appearance

You may not qualify if:

  • endorsed a current major medical condition;
  • met criteria for a full threshold psychiatric disorder (of moderate intensity when severity ratings are necessary, such as for substance use disorders and binge eating disorder);
  • were at high risk for suicide;
  • endorsed current or recent pregnancy or anticipated becoming pregnant within the next year;
  • were taking medication known to affect eating, weight and/or chronic disease risk;
  • were participating in eating, weight, or diabetes programming;
  • experienced weight loss \> 10% in the past six months; and/or
  • could not complete study procedures in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97401, United States

Location

Related Publications (1)

  • Kelly NR, Doty KJ, Schrag BHC, Bryant S, Plezia S, Parr NJ, Budd EL. Feasibility and acceptability of a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appearance. Pilot Feasibility Stud. 2025 Apr 23;11(1):51. doi: 10.1186/s40814-025-01630-8.

MeSH Terms

Conditions

DepressionDisordered Eating Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 24, 2024

Study Start

June 1, 2023

Primary Completion

April 6, 2024

Study Completion

June 1, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Locations