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Singing Your Negative Body-Related Thoughts

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ClinicalTrials.gov Identifier: NCT03646305
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jennifer Mills, York University

Brief 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. increasing body satisfaction, increasing body esteem, decreasing the drive towards thinness), as well as increase mood and self-esteem.
  3. Compare singing to the defusion strategy of verbal repetition, as well as control conditions, to determine the effectiveness of these techniques.
  4. 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.


Condition or disease Intervention/treatment Phase
Body Dissatisfaction Behavioral: Cognitive Defusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Singing Your Negative Body-Related Thoughts: A Randomized Controlled Trial of a New Cognitive Defusion Strategy
Actual Study Start Date : October 3, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : June 27, 2019

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.
Behavioral: Cognitive Defusion
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.

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
Behavioral: Cognitive Defusion
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.

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.
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



Primary Outcome Measures :
  1. Self-Ratings of Thought Appraisals (Visual Analogue Scales) [ Time Frame: 1 week ]
    Five analogue scales was used to measure changes in the participant's perception of a targeted unwanted thought in regards to believability, negativity, avoidance, discomfort, and willingness to have the thought.

  2. Self-Ratings of Cognitive Fusion (Cognitive Fusion Questionnaire) [ Time Frame: 1 week ]
    The Cognitive Fusion Questionnaire will be used to measure changes in cognitive fusion


Secondary Outcome Measures :
  1. Self-ratings of Body Image Cognitions: Body Image Distress (Body Image State Scale) [ Time Frame: 1 week ]
    The Body Image State Scale was used as part of a standard questionnaire package to measure changes in body image cognitions.

  2. Self-Ratings of Body Image Cognitions: Drive for Thinness (Drive for Thinness Subscale of the Eating Disorder Inventory) [ Time Frame: 1 week ]
    The drive for thinness subscale of the Eating Disorder Inventory was used as part of a standard questionnaire package to measure changes in body image cognitions.

  3. Self-Ratings of Body Image Cognitions: Body Dissatisfaction (Visual Analogue Scales) [ Time Frame: 1 week ]
    A series of visual analogue scales of body dissatisfaction and weight dissatisfaction was used as part of a standard questionnaire package to measure changes in body image cognitions.

  4. Self-Ratings of Mood (Visual Analogue Scales) [ Time Frame: 1 week ]
    A series of visual analogue scales was used to assess changes in mood on the dimensions of anxiety, depression, happiness, anger, and confidence.

  5. Self-Ratings of Self-Esteem (State Self Esteem Scale) [ Time Frame: 1 week ]
    The State Self Esteem Scale was used to assess changes in state self esteem

  6. Self-Rating of Homework Adherence (Homework Adherence Questionnaire) [ Time Frame: Homework completion across seven days (14 time points) ]
    Open-ended questionnaire to determine how many time they practiced the strategy over the course of the week and for approximately how long each session.

  7. Self-Rating of Thought-Shape Fusion (Thought-Shape Fusion Questionnaire) [ Time Frame: Baseline ]
    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 her body shape and weight.



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646305


Locations
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Canada, Ontario
York University
Toronto, Ontario, Canada, M3J 1P3
Sponsors and Collaborators
York University
Investigators
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Principal Investigator: Keisha C Gobin, BA York University

Publications:
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.

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Responsible Party: Dr. Jennifer Mills, Professor, York University
ClinicalTrials.gov Identifier: NCT03646305     History of Changes
Other Study ID Numbers: 2018-111
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No