Clinical trial NCT03646305: Singing Your Negative Body-Related Thoughts
Official title: Singing Your Negative Body-Related Thoughts: A Randomized Controlled Trial of a New Cognitive Defusion Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dissatisfaction
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 133
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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).

Primary outcomes:
measure: Self-Ratings of Thought Appraisals (Believability)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Thought Appraisals (Negativity)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-Up (Day 7)
measure: Self-Ratings of Thought Appraisals (Discomfort)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Thought Appraisals (Willingness)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Thought Appraisals (Avoidance)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Cognitive Fusion (Cognitive Fusion Questionnaire)
timeFrame: Baseline and Follow-up (Day 7)
Secondary outcomes:
measure: Self-Ratings of Body Image Cognitions (Weight Dissatisfaction)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Body Image Cognitions (Appearance Dissatisfaction)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-ratings of Body Image Distress (Body Image State Scale)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Mood (Anxiety)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Mood (Depression)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Mood (Happiness)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Mood (Confidence)
timeFrame: Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)
measure: Self-Ratings of Self-Esteem (State Self Esteem Scale)
timeFrame: Baseline and Follow-up (Day 7)
measure: Self-Rating of Homework Adherence (Homework Adherence Questionnaire)
timeFrame: Homework completion across seven days (14 time points)
measure: Self-Rating of Thought-Shape Fusion (Thought-Shape Fusion Questionnaire)
timeFrame: Baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Keisha C Gobin, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.