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OpenTrials
Completed

NCT Number: NCT06610318

Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults

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.

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Key information

Conditions

Feasibility Studies Acceptability Behavior Behavioral Symptoms Depression Depressive Symptoms Disordered Eating Behavior Disordered Eating Behaviors Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Oregon

Eugene, Oregon, 97401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Imagery Rescripting

Behavioral

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.

Nutrition Education

Behavioral

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.

Primary outcomes

  1. enrollment

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

    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

  2. fidelity

    Time frame: during the intervention session only

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

  3. data collection completeness

    Time frame: baseline, intervention, 1-month, and 3-month

    % of missing data collected at all study visits

  4. intervention acceptability

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

    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

  5. safety

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

    frequency of adverse events

  6. retention

    Time frame: from baseline through the 3-month follow-up visit

    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)

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

Brief Strategies for Improving Health Outcomes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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