Body DissatisfactionNCT05863598
Prevention of Eating Disorders Through Optimization of Protective Factors
A study testing Enhancing protective factors and Expressive writing in people with Body Dissatisfaction and Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating… Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Dissatisfaction, Eating Disorders
- What is being tested?
- Enhancing protective factors and Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 644 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Youth and young people (15-20 years) with a subjective experience of body dissatisfaction.
Exclusion Criteria: Indications of depression, or suicidality, as well as presence of an eating disorder, or other conditions that may require medical attention, or conditions that makes it impossible to complete the intervention (e.g., not being able to read and write in Swedish).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Solna, 17177
Ata Ghaderi, PhD, +46-8-524 832 48, ata.ghaderi@ki.se
Ata Ghaderi, PhD
About this study
Official title: A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors
The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder.
The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).
Read the detailed description
Research area and aims:
Eating disorders (EDs) are common and cause significant morbidity and mortality. Due to stigma, only 25% seek help and only 50% fully recover after receiving treatments. Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level. However, current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation. The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable, brief, and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design. A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization.
Research questions:
- How effective is an internet-based prevention program, that reinforces protective factors against EDs, in reducing the onset of EDs 6, 12, 24, and 36 months post-intervention?
- Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)?
- Is prevention of EDs based on reinforcement of protective factors cost-effective?
- How do the participant experience their participation in these two interventions?
Other research questions concern gender differences in enrollment and compliance, potential moderators of outcome, participation in booster sessions, and potential risk for stigma.
- Conditions
- Body Dissatisfaction, Eating Disorders
- Being tested
- Enhancing protective factors, Expressive writing
- Keywords
- eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing protective factorsBehavioural
Participants will watch some short movies and infographics, and will be asked to argue for the importance of body image flexibility, body functionality appreciation, etc.
Expressive writingBehavioural
Participants will reflect and write about any cognitions or emotions they can have in relation to their bodies.
| Study group | Role | What they receive |
|---|---|---|
| Enhancing protective factors | Experimental | Participants will learn to improve their body image through body appreciation tasks, body image flexibility and focus on body functionality appreciation. They also learn to focus on important life values, be more accepting of themselves, and learn to eat regularly and with attention to bodily needs and signals. This is don in interactive ways, and by using a cognitive dissonance frame. Receives: Behavioral: Enhancing protective factors |
| Expressive writing | Placebo comparator | Participants will be instructed to write about any thoughts, feelings, images, memories, interceptions, ideas or emotions related to their body for the same during as the active intervention (i.e., 40 minutes/week across four consecutive weeks). Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).
The Eating disorders examination interview is the gold standard to establish diagnoses of eating disorders and will be used at baseline and to investigate the incidence of eating disorders (ED) during the follow-up period (36 months post intervention). Diagnostic status will be specified based on specific criteria for each ED diagnosis.
Measured: Baseline to 36 months post-intervention
Secondary outcomes (10)
Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).
The Body Shape questionnaire (Brief version: 8 items) measures body dissatisfaction. It has good psychometric properties. Items are scored on a Likert-type scale from 1 (Never) to 6 (Always). Higher scores indicate more body dissatisfaction.
Measured: From baseline, up to 36 months post-intervention
Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).
The Drive for Muscularity Scale (15 items) measures one of the risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 6. Higher scores indicate stronger drive for muscularity.
Measured: From baseline, up to 36 months post-intervention
Change in the internalization of thin ideal through the Ideal Body Stereotype Scale-Revised (IBSS-R: Stice et al, 2008, J Consult Clin Pschol, 76, 329-340)
The Body Stereotype Scale-Revised (6 items) measures the internalization of the current thinness ideal, which is a risk factors for ED. It has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate more internalization of the thin ideal.
Measured: From baseline, up to 36 months post-intervention
Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).
The Brunnsviken Quality of Life Scale is a brief instrument (12 items) developed in Sweden with good psychometrics to measure quality of life. The items are rated on a scale from 0 to 4. Higher scores indicate stronger satisfaction with life.
Measured: From baseline, up to 36 months post-intervention
Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).
The Body Appreciation Scale (10 items) has good psychometrics. The items are scored on a scale from 1 to 5. Higher scores indicate more body appreciation.
Measured: From baseline, up to 36 months post-intervention
Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).
The Functionality Appreciation Scale (7 items) has good psychometrics. Items are rated on a scale from 1 to 5. Higher scores indicate higher appreciation of body functionality.
Measured: From baseline, up to 36 months post-intervention
Change in body image flexibility through the Body Image Acceptance and Action Questionnaire (BI-AAQ-5: Sandoz et al, 2013, J Cont Behav Science, 2, 39-48).
The Body Image Acceptance and Action Questionnaire measures body image flexibility (5 items), which is another protective factor. Items are rated on a scale from 1 to 7. Higher scores indicate more body image flexibility.
Measured: From baseline, up to 36 months post-intervention
Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).
The Intuitive Eating Scale (23 items) is an established measure of intuitive eating. It has good psychometric properties. Items are rated on a scale from 1 to 5. Higher scores indicate more intuitive eating.
Measured: From baseline, up to 36 months post-intervention
Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).
The Self-Compassion Scale (Brief version: 12 items) has good psychometrics. It provides information on an important protective factor. Items are rated on a scale from 1 to 5. Higher scores indicate higher self-compassion.
Measured: From baseline, up to 36 months post-intervention
Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).
The Bull's-Eye Values Survey helps to ascertain what ares in life (i.e., personal values) seem important to each participant. It has been adapted by providing the instructions through a brief instructional video instead of lengthy text. The importance of life directions are rated on a scale from 0 to 7. Higher scores indicate more importance. The proximity to life values is rated on a scale from 1 to 7. Higher scores indicate more proximity, where 7 is the bull's eye.
Measured: From baseline, up to 36 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 May 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Body DissatisfactionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is randomized controlled trials. Participants will be randomized to the active prevention program, or to a placebo (expressive writing). The intervention is brief (four weeks only). Recruitment of the participants (n=644) will take one year (anticipated)After the intervention, they will receive a booster session and will be followed up every 6 months, for 36 months post-intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Linkoeping University
- Responsible party
- Principal investigator, Ata Ghaderi, Karolinska Institutet
- Investigators
- Ata Ghaderi, PhD, Principal investigator, PI employed at Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863598
- Sponsor's protocol ID
- 2022-01039
- Status last verified
- Oct 2024
- First submitted
- 28 Apr 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.
PubMed 32551736Andrew R, Tiggemann M, Clark L. The protective role of body appreciation against media-induced body dissatisfaction. Body Image. 2015 Sep;15:98-104. doi: 10.1016/j.bodyim.2015.07.005. Epub 2015 Aug 24.
PubMed 26311661Atkinson MJ, Wade TD. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study. Int J Eat Disord. 2015 Nov;48(7):1024-37. doi: 10.1002/eat.22416. Epub 2015 Jun 6.
PubMed 26052831Burychka D, Miragall M, Banos RM. Towards a Comprehensive Understanding of Body Image: Integrating Positive Body Image, Embodiment and Self-Compassion. Psychol Belg. 2021 Jul 27;61(1):248-261. doi: 10.5334/pb.1057. eCollection 2021.
PubMed 34394951Homan KJ, Tylka TL. Self-compassion moderates body comparison and appearance self-worth's inverse relationships with body appreciation. Body Image. 2015 Sep;15:1-7. doi: 10.1016/j.bodyim.2015.04.007. Epub 2015 May 16.
PubMed 25978272Levine MP, Smolak L. The role of protective factors in the prevention of negative body image and disordered eating. Eat Disord. 2016;24(1):39-46. doi: 10.1080/10640266.2015.1113826. Epub 2015 Dec 7. No abstract available.
PubMed 26643272Linardon J, Tylka TL, Fuller-Tyszkiewicz M. Intuitive eating and its psychological correlates: A meta-analysis. Int J Eat Disord. 2021 Jul;54(7):1073-1098. doi: 10.1002/eat.23509. Epub 2021 Mar 30.
PubMed 33786858Mensinger JL, Granche JL, Cox SA, Henretty JR. Sexual and gender minority individuals report higher rates of abuse and more severe eating disorder symptoms than cisgender heterosexual individuals at admission to eating disorder treatment. Int J Eat Disord. 2020 Apr;53(4):541-554. doi: 10.1002/eat.23257. Epub 2020 Mar 13.
PubMed 32167198Moffitt RL, Neumann DL, Williamson SP. Comparing the efficacy of a brief self-esteem and self-compassion intervention for state body dissatisfaction and self-improvement motivation. Body Image. 2018 Dec;27:67-76. doi: 10.1016/j.bodyim.2018.08.008. Epub 2018 Aug 23.
PubMed 30144731Ahlen J, Hursti T, Tanner L, Tokay Z, Ghaderi A. Prevention of Anxiety and Depression in Swedish School Children: a Cluster-Randomized Effectiveness Study. Prev Sci. 2018 Feb;19(2):147-158. doi: 10.1007/s11121-017-0821-1.
PubMed 28730396Koller KA, Thompson KA, Miller AJ, Walsh EC, Bardone-Cone AM. Body appreciation and intuitive eating in eating disorder recovery. Int J Eat Disord. 2020 Aug;53(8):1261-1269. doi: 10.1002/eat.23238. Epub 2020 Feb 5.
PubMed 32020677
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors
- ClinicalTrials.gov ID
- NCT05863598
- Acronym / sponsor ID
- 2022-01039
- Conditions
- Body Dissatisfaction, Eating Disorders
- Keywords
- eating disorders, body dissatisfaction, risk factors, buffering factors, incidence, efficacy, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University, Linkoeping University
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 May 2023 (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.
The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder.
The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).
Detailed description
Research area and aims:
Eating disorders (EDs) are common and cause significant morbidity and mortality. Due to stigma, only 25% seek help and only 50% fully recover after receiving treatments. Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level. However, current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation. The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable, brief, and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design. A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization.
Research questions:
- How effective is an internet-based prevention program, that reinforces protective factors against EDs, in reducing the onset of EDs 6, 12, 24, and 36 months post-intervention?
- Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)?
- Is prevention of EDs based on reinforcement of protective factors cost-effective?
- How do the participant experience their participation in these two interventions?
Other research questions concern gender differences in enrollment and compliance, potential moderators of outcome, participation in booster sessions, and potential risk for stigma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is randomized controlled trials. Participants will be randomized to the active prevention program, or to a placebo (expressive writing). The intervention is brief (four weeks only). Recruitment of the participants (n=644) will take one year (anticipated)After the intervention, they will receive a booster session and will be followed up every 6 months, for 36 months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Enhancing protective factors | Experimental | Behavioral: Enhancing protective factorsParticipants will learn to improve their body image through body appreciation tasks, body image flexibility and focus on body functionality appreciation. They also learn to focus on important life values, be more accepting of themselves, and learn to eat regularly and with attention to bodily needs and signals. This is don in interactive ways, and by using a cognitive dissonance frame. |
| Expressive writing | Placebo comparator | Behavioral: Expressive writingParticipants will be instructed to write about any thoughts, feelings, images, memories, interceptions, ideas or emotions related to their body for the same during as the active intervention (i.e., 40 minutes/week across four consecutive weeks). |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Enhancing protective factorsParticipants will watch some short movies and infographics, and will be asked to argue for the importance of body image flexibility, body functionality appreciation, etc. | Behavioural | Enhancing protective factors |
| Expressive writingParticipants will reflect and write about any cognitions or emotions they can have in relation to their bodies. | Behavioural | Expressive writing |
Primary outcome
Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press).
Time frame: Baseline to 36 months post-intervention
The Eating disorders examination interview is the gold standard to establish diagnoses of eating disorders and will be used at baseline and to investigate the incidence of eating disorders (ED) during the follow-up period (36 months post intervention). Diagnostic status will be specified based on specific criteria for each ED diagnosis.
10 secondary outcomes
Change in body dissatisfaction through the Body Shape questionnaire: BSQ (Welch et al, 2011: Beh Res Ther, 49, 85-91).
Time frame: From baseline, up to 36 months post-intervention
Change in drive for muscularity through the Drive for Muscularity Scale (DMS: McCreary& Sasse, 2000, J Am Coll Health, 48, 297-304).
Time frame: From baseline, up to 36 months post-intervention
Change in the internalization of thin ideal through the Ideal Body Stereotype Scale-Revised (IBSS-R: Stice et al, 2008, J Consult Clin Pschol, 76, 329-340)
Time frame: From baseline, up to 36 months post-intervention
Change in quality of life through The Brunnsviken Quality of Life Scale (BBQ: Lindner et al, 2016, Cogn Behav Ther, 45, 182-195).
Time frame: From baseline, up to 36 months post-intervention
Change in body appreciation through the Body Appreciation Scale (BAS: Tylka & Wood-Bacalow, 2015, Body Image, 12, 53-67).
Time frame: From baseline, up to 36 months post-intervention
Change in body functionality appreciation through the Functionality Appreciation Scale (FAS: Alleva et al, 2017, Body Image, 23, 28-44).
Time frame: From baseline, up to 36 months post-intervention
Change in body image flexibility through the Body Image Acceptance and Action Questionnaire (BI-AAQ-5: Sandoz et al, 2013, J Cont Behav Science, 2, 39-48).
Time frame: From baseline, up to 36 months post-intervention
Change in intuitive eating through the Intuitive Eating Scale (IES: Tylka & Kroon Van Diest, 2013, J Cons Psychol, 60,137-153).
Time frame: From baseline, up to 36 months post-intervention
Change in self-compassion through the Self-Compassion Scale (SCS: Raes et al., 2011, Clin Psychol Psychother, 18, 250-255).
Time frame: From baseline, up to 36 months post-intervention
Change in life values through the Bull's-Eye Values Survey (BE-VS: Lundgren et al, 2012, Cogn Behav Pract, 19, 518-526).
Time frame: From baseline, up to 36 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 32551736Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.
- Background: PubMed 26311661Andrew R, Tiggemann M, Clark L. The protective role of body appreciation against media-induced body dissatisfaction. Body Image. 2015 Sep;15:98-104. doi: 10.1016/j.bodyim.2015.07.005. Epub 2015 Aug 24.
- Background: PubMed 26052831Atkinson MJ, Wade TD. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study. Int J Eat Disord. 2015 Nov;48(7):1024-37. doi: 10.1002/eat.22416. Epub 2015 Jun 6.
- Background: PubMed 34394951Burychka D, Miragall M, Banos RM. Towards a Comprehensive Understanding of Body Image: Integrating Positive Body Image, Embodiment and Self-Compassion. Psychol Belg. 2021 Jul 27;61(1):248-261. doi: 10.5334/pb.1057. eCollection 2021.
- Background: PubMed 25978272Homan KJ, Tylka TL. Self-compassion moderates body comparison and appearance self-worth's inverse relationships with body appreciation. Body Image. 2015 Sep;15:1-7. doi: 10.1016/j.bodyim.2015.04.007. Epub 2015 May 16.
- Background: PubMed 26643272Levine MP, Smolak L. The role of protective factors in the prevention of negative body image and disordered eating. Eat Disord. 2016;24(1):39-46. doi: 10.1080/10640266.2015.1113826. Epub 2015 Dec 7. No abstract available.
- Background: PubMed 33786858Linardon J, Tylka TL, Fuller-Tyszkiewicz M. Intuitive eating and its psychological correlates: A meta-analysis. Int J Eat Disord. 2021 Jul;54(7):1073-1098. doi: 10.1002/eat.23509. Epub 2021 Mar 30.
- Background: PubMed 32167198Mensinger JL, Granche JL, Cox SA, Henretty JR. Sexual and gender minority individuals report higher rates of abuse and more severe eating disorder symptoms than cisgender heterosexual individuals at admission to eating disorder treatment. Int J Eat Disord. 2020 Apr;53(4):541-554. doi: 10.1002/eat.23257. Epub 2020 Mar 13.
- Background: PubMed 30144731Moffitt RL, Neumann DL, Williamson SP. Comparing the efficacy of a brief self-esteem and self-compassion intervention for state body dissatisfaction and self-improvement motivation. Body Image. 2018 Dec;27:67-76. doi: 10.1016/j.bodyim.2018.08.008. Epub 2018 Aug 23.
- Background: PubMed 28730396Ahlen J, Hursti T, Tanner L, Tokay Z, Ghaderi A. Prevention of Anxiety and Depression in Swedish School Children: a Cluster-Randomized Effectiveness Study. Prev Sci. 2018 Feb;19(2):147-158. doi: 10.1007/s11121-017-0821-1.
- Background: PubMed 32020677Koller KA, Thompson KA, Miller AJ, Walsh EC, Bardone-Cone AM. Body appreciation and intuitive eating in eating disorder recovery. Int J Eat Disord. 2020 Aug;53(8):1261-1269. doi: 10.1002/eat.23238. Epub 2020 Feb 5.
- Individual participant dataSharing planned: No
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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.
Ata Ghaderi, PhD principal investigator
PI employed at Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing protective factors and Expressive writing in people with Body Dissatisfaction and Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ata Ghaderi, PhD (+46 8 524 832 48, ata.ghaderi@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of eating disorders through the Eating disorders examination (EDE) (Fairburn, 2008, Guilford Press). (time frame: Baseline to 36 months post-intervention). 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 NCT05863598, which also lists 11 linked publications.
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 6 Mar 2025.