Feasibility StudiesEarly Phase 1NCT06610318
Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults
A Early Phase 1 study testing imagery rescripting and nutrition education in people with Feasibility Studies and Acceptability, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies, Acceptability, Depressive Symptoms
- What is being tested?
- imagery rescripting and nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- endorse a history of at least one negative experience related to eating and/or appearance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Strategies for Improving Health Outcomes
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.
- Being tested
- imagery rescripting, nutrition education
- Medical subject headings
- Depression, Disordered Eating Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagery rescriptingBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: during the intervention session only
data collection completeness
% of missing data collected at all study visits
Measured: 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
Measured: these data will be collected during the 1-month follow-up visit
safety
frequency of adverse events
Measured: 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)
Measured: from baseline through the 3-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jun 2023
- Primary completion6 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610318
- Sponsor's protocol ID
- STUDY00000529
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40270079
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Strategies for Improving Health Outcomes
- ClinicalTrials.gov ID
- NCT06610318
- Acronym / sponsor ID
- STUDY00000529
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 6 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imagery rescripting | Experimental | Behavioral: imagery rescriptingThis 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 control | Active comparator | Behavioral: nutrition educationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years old
- endorse a history of at least one negative experience related to eating and/or appearance
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagery rescriptingThis 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. | Behavioural | Imagery rescripting |
| nutrition educationThe 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. | Behavioural | Nutrition education control |
Primary outcome
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
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
data collection completeness
Time frame: baseline, intervention, 1-month, and 3-month
% of missing data collected at all study visits
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 40270079Kelly 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.
- Individual participant dataSharing planned: Undecided
Related trials for Feasibility Studies
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing imagery rescripting and nutrition education in people with Feasibility Studies and Acceptability, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
enrollment (time frame: once, at baseline, over the duration of recruitment to obtain the sample size of interest). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.