- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646305
Singing Your Negative Body-Related Thoughts
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M3J 1P3
- York University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under age 17
- Do not identify as female
- Scores below 15 on the Revised Restraint Scale (Polivy, Herman, & Howard, 1988).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verbally repeat body-related thoughts
A cognitive defusion strategy in which participants repeat a target unwanted thought out loud and as quickly as possible for 60 seconds.
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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.
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Experimental: Sing negative body-related thoughts
A cognitive defusion strategy in which participants sing a target unwanted thought to the tune of 'twinkle, twinkle' for 60 seconds
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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.
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No Intervention: Verbally repeat body-unrelated thoughts
A control condition in which participants repeat the phrase "I am talking" out loud and as quickly as possible for 60 seconds.
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No Intervention: Sing body-unrelated thoughts
A control condition in which participants sing the phrase "I am singing" to the tune of 'twinkle, twinkle' for 60 seconds
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Ratings of Thought Appraisals (Believability)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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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.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Thought Appraisals (Negativity)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
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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.
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Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
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Self-Ratings of Thought Appraisals (Discomfort)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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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.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Thought Appraisals (Willingness)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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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.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Thought Appraisals (Avoidance)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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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.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Cognitive Fusion (Cognitive Fusion Questionnaire)
Time Frame: Baseline and Follow-up (Day 7)
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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.
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Baseline and Follow-up (Day 7)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Ratings of Body Image Cognitions (Weight Dissatisfaction)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their weight dissatisfaction on a visual analogue scale that ranges from 0-100.
Higher scores means greater weight dissatisfaction.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Body Image Cognitions (Appearance Dissatisfaction)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their appearance dissatisfaction on a visual analogue scale that ranges from 0-100.
Higher scores means greater appearance dissatisfaction.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-ratings of Body Image Distress (Body Image State Scale)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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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).
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Mood (Anxiety)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their anxiety on a visual analogue scale that ranges from 0-100.
Higher scores means greater anxiety.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Mood (Depression)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their depressive mood on a visual analogue scale that ranges from 0-100.
Higher scores means greater depressive mood.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Mood (Happiness)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their happiness on a visual analogue scale that ranges from 0-100.
Higher scores means greater happy mood.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Mood (Confidence)
Time Frame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Participants rated their confidence on a visual analogue scale that ranges from 0-100.
Higher scores means greater confidence.
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Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
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Self-Ratings of Self-Esteem (State Self Esteem Scale)
Time Frame: Baseline and Follow-up (Day 7)
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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.
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Baseline and Follow-up (Day 7)
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Self-Rating of Homework Adherence (Homework Adherence Questionnaire)
Time Frame: Homework completion across seven days (14 time points)
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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.
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Homework completion across seven days (14 time points)
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Self-Rating of Thought-Shape Fusion (Thought-Shape Fusion Questionnaire)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keisha C Gobin, BA, York University
Publications and helpful links
General 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.
- Polivy, 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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