Eating Disorder SymptomIMFABNCT04118972
In the Mirror: Functional Appreciated Bodies (IM FAB)
A study testing Mirror exposure and text prompt responses in people with Eating Disorder Symptom and Body Image Disturbance, run by Union College, New York at 2 sites in United States.
Trial summary
The current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Symptom, Body Image Disturbance
- What is being tested?
- Mirror exposure and text prompt responses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2018to 1 Dec 2021
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate female aged 18-23 years.
Who cannot join
- Self-definition as having an active eating disorder
- Participation in the Body Project
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University at Albany, State University of New York
Albany, New York, 12222
Union College
Schenectady, New York, 12308
About this study
Official title: In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program
The current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and decrease eating disorder symptoms in a sample of undergraduate females, a population at particularly high risk of body image dissatisfaction and consequent eating disorder development.
Read the detailed description
Specific Aim 1. First, the project aims to test a gratitude-based body functionality primary prevention program, In the Mirror: Functional Appreciated Bodies (IM FAB), that incorporates mirror exposure with a greater intervention "dose" than that piloted by Brooks and Walker. The increased dose should allow for greater ability for participants to consolidate exposure-based learning. Specifically, more time instructed to appreciate the body's functionality allows for more occasions to redirect critical appearance-oriented cognitions to appreciative, function-based cognitions.
Specific Aim 2. Second, the project aims to pilot test a relatively minimalistic intervention that would be easily translated to app-based delivery format, to help overcome the most-cited barriers to prevention program participation noted by undergraduate students in universal prevention research. Specifically, undergraduate participants who were assigned to a prevention program but did not enroll questioned a need for counseling/therapy, reported preferring to deal with issues on their own, and cited a lack of time as reasons they did not enroll.
Specific Aim 3. Third, the project aims to test this specific functionality mirror exposure approach largely on its own, rather than as part of a multicomponent treatment program, so that its unique contribution in preventing body image dissatisfaction, and ultimately eating disorders, can be assessed. A main goal in prevention and treatment development remains to continuously test components of body-image interventions separately for efficacy.
- Conditions
- Eating Disorder Symptom, Body Image Disturbance
- Being tested
- Mirror exposure and text prompt responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror exposure and text prompt responsesBehavioural
Participants in the active interventions have three weekly mirror exposure sessions that are either guided with specific instructions as to where to look and how (only in functionality condition)
| Study group | Role | What they receive |
|---|---|---|
| Functionality Mirror Exposure & Journal | Experimental | A text-based functionality gratitude "journaling" prompt three times weekly paired with three weeks of weekly functionality-based guided mirror exposure sessions in the lab (the IM FAB program) Receives: Behavioral: Mirror exposure and text prompt responses |
| Pure Mirror Exposure & Gratitude Journal | Active comparator | Thrice weekly generic (non body-focused) gratitude text prompts and pure mirror exposure in the lab. Participants are not given instructions on how to examine body parts, only instructed to examine the same specific body parts as the Functionality group to control specifically for impacts of the body functionality focus. Receives: Behavioral: Mirror exposure and text prompt responses |
| Assessment only control | No intervention | Assessments at Week 1, Week 3, and 1- and 4-month follow-ups, identical to those received by participants in the active condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000)
69-item questionnaire with Likert-type scale ranging from 1-5. Trait body image satisfaction with subscales assessing: Appearance Evaluation, Appearance Orientation, Fitness Evaluation, Fitness Orientation, Health Evaluation, Health Orientation, Illness Orientation, Body Areas Satisfaction, Overweight Preoccupation, and Self-Classified Weight; Scores are averaged for each subscale with a range of 1-5. Fitness, Health, and Appearance Evaluation scores that are higher reflect more positive attitudes about one's fitness, health, and appearance, respectively. Higher appearance, fitness, health, and illness orientation, and overweight preoccupation scores reflect greater investment in appearance, health, concerns about becoming ill, fitness, and preoccupation with weight. Higher Body Areas Satisfaction reflects more positive body image. Higher self-classified weight reflects self-reported higher weight categorization (e.g., overweight or obese)
Measured: Change from Baseline MBSRQ scores to 20 weeks
Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004)
Eating disorder diagnostic scale for the DSM-5. This is a diagnostic measure, so participants respond to questions regarding binge eating, purging and other compensatory behaviors, weight and shape concern, weight loss, height, weight, and fear of weight gain to determine whether they meet diagnostic criteria for anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, low frequency bulimia nervosa, low frequency binge eating disorder, purging disorder, or night eating syndrome. See http://www.ori.org/files/Static%20Page%20Files/EDDS_5.pdf for specific scoring instructions. Higher scale scores represent greater eating disorder pathology. As a diagnostic tool, respondents need to meet DSM-5 criteria for an eating disorder based on specific item responses, and would be scored as indicating a specific eating disorder diagnosis based on those specific item responses.
Measured: Change from baseline EDDS scores to 20 weeks
Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002)
Body checking questionnaire. 23-item 5-point Likert-type scale ranging from 1-5. Three subscales assess: Overall appearance checking, specific body part checking, and idiosyncratic checking. Items are summed for for each subscale and for a total score. Total score ranges from 23-115. Higher scores reflect greater frequency of body checking behaviors.
Measured: Change from baseline BCQ scores to 20 weeks
Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991)
Body image avoidance questionnaire. Measures avoidance of one's body across a range of evaluative contexts. 19 6-point Likert-type scale ranging from 0-5, with three items reverse scored (12, 13, and 19). Items are summed, with a possible range from 0-95. Higher scores reflect greater body image avoidance and are typically associated with greater psychopathology.
Measured: Change from baseline BIAQ scores to 20 weeks
Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015)
Body appreciation measure. 10-item 5-point Likert-type scale. Items reflect accepting and holding positive views about one's body. Items are averaged with higher scores reflecting great body appreciation.
Measured: Change from baseline BAS-2 scores to 20 weeks
Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017)
Scale assesses appreciation of the body's functions. 7-item 5-point Likert-type scale with items ranging from 1-5. Items are averaged with greater scores reflecting greater appreciation of the functions and capabilities of one's body.
Measured: Change from baseline FAS scores to 20 weeks
Secondary outcomes (3)
Usability Metric for User Experience (UMUX; Finstad, 2010)
4 7-point Likert-type items ranging from 0-6, after recoding, which assesses the usability and ease of the IMFAB protocol. The items are summed for a possible range of 0-24 points, with greater scores representing greater usability of the technology or protocol in question.
Measured: Post-Intervention (Week 3)
Feasibility of mobile application scale, derived from UMUX format
5 7-point Likert-scale items and one open-ended item assessing feasibility of the IMFAB protocol delivery via mobile application. Questions range from 0-6 after recoding and are summed. Greater scores reflect higher ratings of feasibility of adopting IMFAB in mobile application format.
Measured: Post-Intervention (Week 3)
Engagement with IMFAB protocol scale, derived from UMUX format.
9 7-point Likert-type scale items \& 3 open-ended questions assessing participant engagement with IM FAB protocol. Likert-type items range from 0-6 and are summed after reverse coding. Greater scores reflect more positive attitudes toward the intervention design (e.g., mirror exposure exercises and gratitude text prompts).
Measured: Post-Intervention (Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Apr 2018
- Primary completion1 Jul 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder SymptomStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two active conditions or a control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union College, New York
- Sponsor type
- University, hospital or other
- Collaborators
- University at Albany
- Responsible party
- Principal investigator, Catherine Walker, Union College, New York
- Investigators
- D. Catherine Walker, Principal investigator, Union College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118972
- Sponsor's protocol ID
- UnionC
- Acronym
- IMFAB
- Status last verified
- Dec 2023
- First submitted
- 9 Oct 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared 6 months after initial publication of data analyses from the current study. Researchers will need to submit a proposal for access to the dataset and demonstrate IRB approval for secondary analysis of the data, if using the dataset for research purposes.
Publications
Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
PubMed 16864251Cash TF, Green GK. Body weight and body image among college women: perception, cognition, and affect. J Pers Assess. 1986 Summer;50(2):290-301. doi: 10.1207/s15327752jpa5002_15.
PubMed 3761129Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
PubMed 25462882Reas DL, Whisenhunt BL, Netemeyer R, Williamson DA. Development of the body checking questionnaire: a self-report measure of body checking behaviors. Int J Eat Disord. 2002 Apr;31(3):324-33. doi: 10.1002/eat.10012.
PubMed 11920995Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
PubMed 28822275Stice E, Telch CF, Rizvi SL. Development and validation of the Eating Disorder Diagnostic Scale: a brief self-report measure of anorexia, bulimia, and binge-eating disorder. Psychol Assess. 2000 Jun;12(2):123-31. doi: 10.1037//1040-3590.12.2.123.
PubMed 10887758Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
PubMed 15023093Froh JJ, Fan J, Emmons RA, Bono G, Huebner ES, Watkins P. Measuring gratitude in youth: assessing the psychometric properties of adult gratitude scales in children and adolescents. Psychol Assess. 2011 Jun;23(2):311-24. doi: 10.1037/a0021590.
PubMed 21443367
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In the Mirror: Functional Appreciated Bodies (IM FAB): Piloting an Easily Disseminable Primary Prevention Program
- ClinicalTrials.gov ID
- NCT04118972
- Acronym / sponsor ID
- IMFAB / UnionC
- Conditions
- Eating Disorder Symptom, Body Image Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Union College, New YorkUniversity, hospital or other
- Collaborators
- University at Albany
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 8 Oct 2019 (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 current project aims to examine the concept of promoting attention toward body functionality and gratitude using a weekly functionality-based mirror exposure and body functionality gratitude "journaling" text prompts three days a week for three weeks to examine whether this helps foster positive body image and decrease eating disorder symptoms in a sample of undergraduate females, a population at particularly high risk of body image dissatisfaction and consequent eating disorder development.
Detailed description
Specific Aim 1. First, the project aims to test a gratitude-based body functionality primary prevention program, In the Mirror: Functional Appreciated Bodies (IM FAB), that incorporates mirror exposure with a greater intervention "dose" than that piloted by Brooks and Walker. The increased dose should allow for greater ability for participants to consolidate exposure-based learning. Specifically, more time instructed to appreciate the body's functionality allows for more occasions to redirect critical appearance-oriented cognitions to appreciative, function-based cognitions.
Specific Aim 2. Second, the project aims to pilot test a relatively minimalistic intervention that would be easily translated to app-based delivery format, to help overcome the most-cited barriers to prevention program participation noted by undergraduate students in universal prevention research. Specifically, undergraduate participants who were assigned to a prevention program but did not enroll questioned a need for counseling/therapy, reported preferring to deal with issues on their own, and cited a lack of time as reasons they did not enroll.
Specific Aim 3. Third, the project aims to test this specific functionality mirror exposure approach largely on its own, rather than as part of a multicomponent treatment program, so that its unique contribution in preventing body image dissatisfaction, and ultimately eating disorders, can be assessed. A main goal in prevention and treatment development remains to continuously test components of body-image interventions separately for efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of two active conditions or a control group.
| Arm | Type | Receives |
|---|---|---|
| Functionality Mirror Exposure & Journal | Experimental | Behavioral: Mirror exposure and text prompt responsesA text-based functionality gratitude "journaling" prompt three times weekly paired with three weeks of weekly functionality-based guided mirror exposure sessions in the lab (the IM FAB program) |
| Pure Mirror Exposure & Gratitude Journal | Active comparator | Behavioral: Mirror exposure and text prompt responsesThrice weekly generic (non body-focused) gratitude text prompts and pure mirror exposure in the lab. Participants are not given instructions on how to examine body parts, only instructed to examine the same specific body parts as the Functionality group to control specifically for impacts of the body functionality focus. |
| Assessment only control | No intervention | –Assessments at Week 1, Week 3, and 1- and 4-month follow-ups, identical to those received by participants in the active condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergraduate female aged 18-23 years.
Key exclusion criteria (2 listed)
- Self-definition as having an active eating disorder
- Participation in the Body Project
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 |
|---|---|---|
| Mirror exposure and text prompt responsesParticipants in the active interventions have three weekly mirror exposure sessions that are either guided with specific instructions as to where to look and how (only in functionality condition) | Behavioural | Functionality Mirror Exposure & Journal, Pure Mirror Exposure & Gratitude Journal |
Primary outcome
Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000)
Time frame: Change from Baseline MBSRQ scores to 20 weeks
69-item questionnaire with Likert-type scale ranging from 1-5. Trait body image satisfaction with subscales assessing: Appearance Evaluation, Appearance Orientation, Fitness Evaluation, Fitness Orientation, Health Evaluation, Health Orientation, Illness Orientation, Body Areas Satisfaction, Overweight Preoccupation, and Self-Classified Weight; Scores are averaged for each subscale with a range of 1-5. Fitness, Health, and Appearance Evaluation scores that are higher reflect more positive attitudes about one's fitness, health, and appearance, respectively. Higher appearance, fitness, health, and illness orientation, and overweight preoccupation scores reflect greater investment in appearance, health, concerns about becoming ill, fitness, and preoccupation with weight. Higher Body Areas Satisfaction reflects more positive body image. Higher self-classified weight reflects self-reported higher weight categorization (e.g., overweight or obese)
Change in Eating Disorder Diagnostic Scale scores (EDDS; Stice, Fisher & Martinez, 2004)
Time frame: Change from baseline EDDS scores to 20 weeks
Eating disorder diagnostic scale for the DSM-5. This is a diagnostic measure, so participants respond to questions regarding binge eating, purging and other compensatory behaviors, weight and shape concern, weight loss, height, weight, and fear of weight gain to determine whether they meet diagnostic criteria for anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, low frequency bulimia nervosa, low frequency binge eating disorder, purging disorder, or night eating syndrome. See http://www.ori.org/files/Static%20Page%20Files/EDDS_5.pdf for specific scoring instructions. Higher scale scores represent greater eating disorder pathology. As a diagnostic tool, respondents need to meet DSM-5 criteria for an eating disorder based on specific item responses, and would be scored as indicating a specific eating disorder diagnosis based on those specific item responses.
Change in Body Checking Questionnaire scores (BCQ; Reas, Whisenhunt, Netemeyer, & Williamson, 2002)
Time frame: Change from baseline BCQ scores to 20 weeks
Body checking questionnaire. 23-item 5-point Likert-type scale ranging from 1-5. Three subscales assess: Overall appearance checking, specific body part checking, and idiosyncratic checking. Items are summed for for each subscale and for a total score. Total score ranges from 23-115. Higher scores reflect greater frequency of body checking behaviors.
Change in Body Image Avoidance Questionnaire scores (BIAQ; Rosen, Srebnik, Saltzberg, & Wendt, 1991)
Time frame: Change from baseline BIAQ scores to 20 weeks
Body image avoidance questionnaire. Measures avoidance of one's body across a range of evaluative contexts. 19 6-point Likert-type scale ranging from 0-5, with three items reverse scored (12, 13, and 19). Items are summed, with a possible range from 0-95. Higher scores reflect greater body image avoidance and are typically associated with greater psychopathology.
Change in Body Appreciation Scale-2 scores (BAS-2; Tylka, & Wood-Barcalow, 2015)
Time frame: Change from baseline BAS-2 scores to 20 weeks
Body appreciation measure. 10-item 5-point Likert-type scale. Items reflect accepting and holding positive views about one's body. Items are averaged with higher scores reflecting great body appreciation.
Change in Functional Appreciation Scale scores (FAS; Alleva, Tylka, & Van Deist, 2017)
Time frame: Change from baseline FAS scores to 20 weeks
Scale assesses appreciation of the body's functions. 7-item 5-point Likert-type scale with items ranging from 1-5. Items are averaged with greater scores reflecting greater appreciation of the functions and capabilities of one's body.
3 secondary outcomes
Usability Metric for User Experience (UMUX; Finstad, 2010)
Time frame: Post-Intervention (Week 3)
Feasibility of mobile application scale, derived from UMUX format
Time frame: Post-Intervention (Week 3)
Engagement with IMFAB protocol scale, derived from UMUX format.
Time frame: Post-Intervention (Week 3)
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 12 Dec 2023.
- Background: PubMed 16864251Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
- Background: PubMed 3761129Cash TF, Green GK. Body weight and body image among college women: perception, cognition, and affect. J Pers Assess. 1986 Summer;50(2):290-301. doi: 10.1207/s15327752jpa5002_15.
- Background: PubMed 25462882Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
- Background: PubMed 11920995Reas DL, Whisenhunt BL, Netemeyer R, Williamson DA. Development of the body checking questionnaire: a self-report measure of body checking behaviors. Int J Eat Disord. 2002 Apr;31(3):324-33. doi: 10.1002/eat.10012.
- Background: PubMed 28822275Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
- Background: PubMed 10887758Stice E, Telch CF, Rizvi SL. Development and validation of the Eating Disorder Diagnostic Scale: a brief self-report measure of anorexia, bulimia, and binge-eating disorder. Psychol Assess. 2000 Jun;12(2):123-31. doi: 10.1037//1040-3590.12.2.123.
- Background: PubMed 15023093Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
- Background: PubMed 21443367Froh JJ, Fan J, Emmons RA, Bono G, Huebner ES, Watkins P. Measuring gratitude in youth: assessing the psychometric properties of adult gratitude scales in children and adolescents. Psychol Assess. 2011 Jun;23(2):311-24. doi: 10.1037/a0021590.
- Individual participant dataSharing planned: Yes. IPD will be shared 6 months after initial publication of data analyses from the current study. Researchers will need to submit a proposal for access to the dataset and demonstrate IRB approval for secondary analysis of the data, if using the dataset for research purposes.
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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. This study is not recruiting at the moment.
D. Catherine Walker principal investigator
Union College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror exposure and text prompt responses in people with Eating Disorder Symptom and Body Image Disturbance, run by Union College, New York at 2 sites 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 1 inclusion and 2 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Change in Multidimensional Body Self-Relations Questionnaire scores (MBSRQ; Cash, 2000) (time frame: Change from Baseline MBSRQ scores to 20 weeks). 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 NCT04118972, which also lists 8 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 12 Dec 2023.