Body DissatisfactionNCT03646305
Singing Your Negative Body-Related Thoughts
A study testing Cognitive Defusion in people with Body Dissatisfaction, run by York University at 1 site in Canada.
Trial summary
Study Objectives: 1. Examine whether singing can be used as a cognitive defusion strategy to change one's appraisals of body-related thoughts so they are less threatening to the individual. 2. Explore whether this technique can change the appraisals of one's body (i.e. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Dissatisfaction
- What is being tested?
- Cognitive Defusion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Restrained eaters, as indicated by a score of 15 or greater on the Revised Restraint Scale (Polivy, Herman, \& Howard, 1988)
- Identify as female
- Age 17 and older
Who cannot join
- Under age 17
- Do not identify as female
- Scores below 15 on the Revised Restraint Scale (Polivy, Herman, \& Howard, 1988).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Singing Your Negative Body-Related Thoughts: A Randomized Controlled Trial of a New Cognitive Defusion Strategy
Study Objectives:
- Examine whether singing can be used as a cognitive defusion strategy to change one's appraisals of body-related thoughts so they are less threatening to the individual.
- Explore whether this technique can change the appraisals of one's body (i.e. increasing body satisfaction, increasing body esteem, decreasing the drive towards thinness), as well as increase mood and self-esteem.
- Compare singing to the defusion strategy of verbal repetition, as well as control conditions, to determine the effectiveness of these techniques.
- Examine whether defusion techniques would be particularly beneficial for individuals with high thought-shape fusion
Read more
Study Hypotheses:
The primary hypothesis was that the cognitive defusion conditions, namely verbal repetition and singing, would foster greater detachment (i.e. defusion) from negative body-related thoughts and change thought appraisals such that these thoughts were less believable and less negative, and the individual was more willing, less likely to avoid, and less uncomfortable when engaging with these thoughts than the control conditions.
Secondary hypotheses propose that these defusion techniques will reduce negative body-related cognitions such as body image distress, drive for thinness, and body dissatisfaction to a greater extent than the control conditions. Moreover, compared to the control condition, these techniques are expected to be superior in reducing negative mood and improving self-esteem. Finally, better outcomes are expected from those in the defusion conditions who practice the technique as instructed (i.e. better homework adherence). Due to the novelty of this intervention, no specific hypotheses have been made regarding whether singing will equal or differ from verbal repetition on the aforementioned outcome measures. Moreover, due to the exploratory nature of applying defusion techniques with individuals with thought-shape fusion, no specific hypotheses have been made around anticipated changes in the perception of the thought, body image satisfaction, mood, self-esteem, and cognitive defusion within this population.
Read the detailed description
Eating disorders are characterized by intense mental preoccupation with body shape and weight. Even in the absence of disordered eating, high levels of body dissatisfaction prospectively predict depression and low self-esteem in young women. Common intervention strategies, such as challenging the validity of negative body-related thoughts, often have limited success. Recent research suggests that accepting, rather than challenging, negative body-related thoughts may reduce body image distress by changing the relationship with those thoughts. For example, continually repeating or even singing an unwanted thought has been shown to reduce the believability and discomfort associated with that thought, through a technique known as cognitive defusion. The current study aims to extend the literature on cognitive defusion and test its effectiveness in the treatment of body dissatisfaction. In a randomized controlled trial design, 122 female restrained eaters were randomly assigned to practice either 1) verbally repeating negative body-related thoughts, 2) singing negative body-related thoughts, 3) verbally repeating body-unrelated thoughts (control), or 4) singing body-unrelated thoughts (control). The goal of this study was to determine whether singing one's negative body-related thoughts could lead to greater changes in perception of the thought, body image satisfaction, mood, and self-esteem relative to a control condition when practiced twice daily for one week.
- Conditions
- Body Dissatisfaction
- Being tested
- Cognitive Defusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive DefusionBehavioural
Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, \& Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought.
| Study group | Role | What they receive |
|---|---|---|
| Verbally repeat body-related thoughts | Experimental | A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds. Receives: Behavioral: Cognitive Defusion |
| Sing negative body-related thoughts | Experimental | A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds Receives: Behavioral: Cognitive Defusion |
| Verbally repeat body-unrelated thoughts | No intervention | A control condition in which participants repeat the phrase "I am talking" out loud and as quickly as possible for 60 seconds. |
| Sing body-unrelated thoughts | No intervention | A control condition in which participants sing the phrase "I am singing" to the tune of 'twinkle, twinkle' for 60 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Ratings of Thought Appraisals (Believability)
Participants rated the believability of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means greater believability of this negative thought.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Thought Appraisals (Negativity)
Participants rated the negativity of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that the negative thought is perceived to be more negative.
Measured: Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
Self-Ratings of Thought Appraisals (Discomfort)
Participants rated the discomfort of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that the thought is perceived to be more uncomfortable.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Thought Appraisals (Willingness)
Participants rated their willingness to have their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that they are more willing to have the thought.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Thought Appraisals (Avoidance)
Participants rated their avoidance of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means greater avoidance of the thought.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Cognitive Fusion (Cognitive Fusion Questionnaire)
The Cognitive Fusion Questionnaire includes 7 items measured on a 7 item Likert scale and will be used to measure changes in cognitive fusion. Higher scores indicate higher degree of cognitive fusion. Total scores can range from 7 to 49.
Measured: Baseline and Follow-up (Day 7)
Secondary outcomes (10)
Self-Ratings of Body Image Cognitions (Weight Dissatisfaction)
Participants rated their weight dissatisfaction on a visual analogue scale that ranges from 0-100. Higher scores means greater weight dissatisfaction.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Body Image Cognitions (Appearance Dissatisfaction)
Participants rated their appearance dissatisfaction on a visual analogue scale that ranges from 0-100. Higher scores means greater appearance dissatisfaction.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-ratings of Body Image Distress (Body Image State Scale)
The Body Image State Scale was used as part of a standard questionnaire package to measure changes in body image cognitions. Participants rated 6 items on a 9-point Likert scale ranging from 1 to 9, for a possible total score of 6 to 54, with higher scores indicating greater body image satisfaction (i.e. positive body image).
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Anxiety)
Participants rated their anxiety on a visual analogue scale that ranges from 0-100. Higher scores means greater anxiety.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Depression)
Participants rated their depressive mood on a visual analogue scale that ranges from 0-100. Higher scores means greater depressive mood.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Happiness)
Participants rated their happiness on a visual analogue scale that ranges from 0-100. Higher scores means greater happy mood.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Confidence)
Participants rated their confidence on a visual analogue scale that ranges from 0-100. Higher scores means greater confidence.
Measured: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Self-Esteem (State Self Esteem Scale)
The State Self Esteem Scale is a 20-item measure used to assess changes in state self esteem, rated on a 5-point Likert scale. Total scores can range from 5 to 100. Higher scores indicate higher self-esteem.
Measured: Baseline and Follow-up (Day 7)
Self-Rating of Homework Adherence (Homework Adherence Questionnaire)
Homework adherence was determined by the total number of seconds spent practicing the defusion technique over the course of the week. There is no total scale range available for this measure.
Measured: Homework completion across seven days (14 time points)
Self-Rating of Thought-Shape Fusion (Thought-Shape Fusion Questionnaire)
The Thought-Shape Fusion Questionnaire was used to assess the extent to which thinking about a forbidden food or behaviour produces a change in one's perception of their body shape and weight. It is a 34-item measure that asks participants to rate how well an item describes them on a 5 point Likert scale from 0 to 4. Total scores can range from 0 to 136, with higher scores indicating greater fusion to body- or food-related thoughts.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start3 Oct 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body DissatisfactionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a single-center, parallel-group study with balanced randomization of participants into four conditions; two experimental and two control \[1:1:1:1\]. This is a non-inferiority study to examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jennifer Mills, York University
- Investigators
- Keisha C Gobin, BA, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646305
- Sponsor's protocol ID
- 2018-111
- Status last verified
- Apr 2021
- First submitted
- 20 Aug 2018
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
PubMed 16300724Polivy, J., Herman, P. H., & Howard, K. I. (1988). Restraint scale: Assessment of dieting. In M. Hersen & A. S. Bel lack (Eds.), Dictionary of behavioral assessment techniques (pp. 377- 380). Elmsford, NY: Pergamon Press.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing Your Negative Body-Related Thoughts: A Randomized Controlled Trial of a New Cognitive Defusion Strategy
- ClinicalTrials.gov ID
- NCT03646305
- Acronym / sponsor ID
- 2018-111
- Conditions
- Body Dissatisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objectives:
- Examine whether singing can be used as a cognitive defusion strategy to change one's appraisals of body-related thoughts so they are less threatening to the individual.
- Explore whether this technique can change the appraisals of one's body (i.e. increasing body satisfaction, increasing body esteem, decreasing the drive towards thinness), as well as increase mood and self-esteem.
- Compare singing to the defusion strategy of verbal repetition, as well as control conditions, to determine the effectiveness of these techniques.
- Examine whether defusion techniques would be particularly beneficial for individuals with high thought-shape fusion
Study Hypotheses:
The primary hypothesis was that the cognitive defusion conditions, namely verbal repetition and singing, would foster greater detachment (i.e. defusion) from negative body-related thoughts and change thought appraisals such that these thoughts were less believable and less negative, and the individual was more willing, less likely to avoid, and less uncomfortable when engaging with these thoughts than the control conditions.
Secondary hypotheses propose that these defusion techniques will reduce negative body-related cognitions such as body image distress, drive for thinness, and body dissatisfaction to a greater extent than the control conditions. Moreover, compared to the control condition, these techniques are expected to be superior in reducing negative mood and improving self-esteem. Finally, better outcomes are expected from those in the defusion conditions who practice the technique as instructed (i.e. better homework adherence). Due to the novelty of this intervention, no specific hypotheses have been made regarding whether singing will equal or differ from verbal repetition on the aforementioned outcome measures. Moreover, due to the exploratory nature of applying defusion techniques with individuals with thought-shape fusion, no specific hypotheses have been made around anticipated changes in the perception of the thought, body image satisfaction, mood, self-esteem, and cognitive defusion within this population.
Detailed description
Eating disorders are characterized by intense mental preoccupation with body shape and weight. Even in the absence of disordered eating, high levels of body dissatisfaction prospectively predict depression and low self-esteem in young women. Common intervention strategies, such as challenging the validity of negative body-related thoughts, often have limited success. Recent research suggests that accepting, rather than challenging, negative body-related thoughts may reduce body image distress by changing the relationship with those thoughts. For example, continually repeating or even singing an unwanted thought has been shown to reduce the believability and discomfort associated with that thought, through a technique known as cognitive defusion. The current study aims to extend the literature on cognitive defusion and test its effectiveness in the treatment of body dissatisfaction. In a randomized controlled trial design, 122 female restrained eaters were randomly assigned to practice either 1) verbally repeating negative body-related thoughts, 2) singing negative body-related thoughts, 3) verbally repeating body-unrelated thoughts (control), or 4) singing body-unrelated thoughts (control). The goal of this study was to determine whether singing one's negative body-related thoughts could lead to greater changes in perception of the thought, body image satisfaction, mood, and self-esteem relative to a control condition when practiced twice daily for one week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This was a single-center, parallel-group study with balanced randomization of participants into four conditions; two experimental and two control [1:1:1:1]. This is a non-inferiority study to examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.
| Arm | Type | Receives |
|---|---|---|
| Verbally repeat body-related thoughts | Experimental | Behavioral: Cognitive DefusionA cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds. |
| Sing negative body-related thoughts | Experimental | Behavioral: Cognitive DefusionA cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds |
| Verbally repeat body-unrelated thoughts | No intervention | –A control condition in which participants repeat the phrase "I am talking" out loud and as quickly as possible for 60 seconds. |
| Sing body-unrelated thoughts | No intervention | –A control condition in which participants sing the phrase "I am singing" to the tune of 'twinkle, twinkle' for 60 seconds |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Restrained eaters, as indicated by a score of 15 or greater on the Revised Restraint Scale (Polivy, Herman, \& Howard, 1988)
- Identify as female
- Age 17 and older
Key exclusion criteria (3 listed)
- Under age 17
- Do not identify as female
- Scores below 15 on the Revised Restraint Scale (Polivy, Herman, \& Howard, 1988).
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 |
|---|---|---|
| Cognitive DefusionCognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, \& Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought. | Behavioural | Sing negative body-related thoughts, Verbally repeat body-related thoughts |
Primary outcome
Self-Ratings of Thought Appraisals (Believability)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Participants rated the believability of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means greater believability of this negative thought.
Self-Ratings of Thought Appraisals (Negativity)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
Participants rated the negativity of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that the negative thought is perceived to be more negative.
Self-Ratings of Thought Appraisals (Discomfort)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Participants rated the discomfort of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that the thought is perceived to be more uncomfortable.
Self-Ratings of Thought Appraisals (Willingness)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Participants rated their willingness to have their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means that they are more willing to have the thought.
Self-Ratings of Thought Appraisals (Avoidance)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Participants rated their avoidance of their body-related thought on a visual analogue scale that ranges from 0-100. Higher scores means greater avoidance of the thought.
Self-Ratings of Cognitive Fusion (Cognitive Fusion Questionnaire)
Time frame: Baseline and Follow-up (Day 7)
The Cognitive Fusion Questionnaire includes 7 items measured on a 7 item Likert scale and will be used to measure changes in cognitive fusion. Higher scores indicate higher degree of cognitive fusion. Total scores can range from 7 to 49.
10 secondary outcomes
Self-Ratings of Body Image Cognitions (Weight Dissatisfaction)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Body Image Cognitions (Appearance Dissatisfaction)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-ratings of Body Image Distress (Body Image State Scale)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Anxiety)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Depression)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Happiness)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Mood (Confidence)
Time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Self-Ratings of Self-Esteem (State Self Esteem Scale)
Time frame: Baseline and Follow-up (Day 7)
Self-Rating of Homework Adherence (Homework Adherence Questionnaire)
Time frame: Homework completion across seven days (14 time points)
Self-Rating of Thought-Shape Fusion (Thought-Shape Fusion Questionnaire)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16300724Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- BackgroundPolivy, J., Herman, P. H., & Howard, K. I. (1988). Restraint scale: Assessment of dieting. In M. Hersen & A. S. Bel lack (Eds.), Dictionary of behavioral assessment techniques (pp. 377- 380). Elmsford, NY: Pergamon Press.
Related trials for Body Dissatisfaction
Not yet recruiting
Expand Your Horizon-Spanish
Body Image, Body Image Dissatisfaction
Active, not recruitingObservational study
Triggers of Eating Disorders in Athletes
Eating Disorders
Not yet recruitingObservational study
Sexual Quality of Life in Female Patients With Lipodystrophy Syndromes or Turner's Syndrome: a Case-control Study
Lipodystrophy Congenital Generalized, Lipodystrophy, Familial Partial
Active, not recruiting
Pilot Trial of the Body Image Program to Prevent Eating Disorders in Female University Students in Mexico
Eating Disorders, Body Dissatisfaction
Recruiting
Young Athlete Body Project - Prevention of Body Dissatisfaction and Eating Disorders Among Adolescent Athletes
Eating Disorders in Adolescence, Body Dissatisfaction
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.
Keisha C Gobin, BA principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Defusion in people with Body Dissatisfaction, run by York University at 1 site in Canada.
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 3 inclusion and 3 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 11 May 2021. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Ratings of Thought Appraisals (Believability) (time frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)). 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 NCT03646305, which also lists 2 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 11 May 2021.