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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03646305
Other study ID # 2018-111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2018
Est. completion date January 30, 2019

Study information

Verified date April 2021
Source York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada York University Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
York University

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Primary 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. Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
Primary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Primary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Primary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Primary 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. Baseline and Follow-up (Day 7)
Secondary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary 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). Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary Self-Ratings of Mood (Anxiety) Participants rated their anxiety on a visual analogue scale that ranges from 0-100. Higher scores means greater anxiety. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary 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. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary Self-Ratings of Mood (Confidence) Participants rated their confidence on a visual analogue scale that ranges from 0-100. Higher scores means greater confidence. Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
Secondary 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. Baseline and Follow-up (Day 7)
Secondary 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. Homework completion across seven days (14 time points)
Secondary 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. Baseline
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