NCT03646305

Brief Summary

Study Objectives:

  1. 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. 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. 3.Compare singing to the defusion strategy of verbal repetition, as well as control conditions, to determine the effectiveness of these techniques.
  4. 4.Examine whether defusion techniques would be particularly beneficial for individuals with high thought-shape fusion

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 5, 2021

Completed
Last Updated

May 11, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

August 20, 2018

Results QC Date

August 29, 2019

Last Update Submit

April 21, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (10)

  • Self-Ratings of Body Image Cognitions (Weight Dissatisfaction)

    Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)

  • Self-Ratings of Body Image Cognitions (Appearance Dissatisfaction)

    Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)

  • Self-ratings of Body Image Distress (Body Image State Scale)

    Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)

  • Self-Ratings of Mood (Anxiety)

    Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)

  • Self-Ratings of Mood (Depression)

    Baseline, Post-Intervention (Day 1), and Follow-up (Day 7)

  • +5 more secondary outcomes

Study Arms (4)

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.

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

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

Interventions

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.

Sing negative body-related thoughtsVerbally repeat body-related thoughts

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under age 17
  • Do not identify as female
  • Scores below 15 on the Revised Restraint Scale (Polivy, Herman, \& Howard, 1988).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related 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. doi: 10.1016/j.brat.2005.06.006.

    PMID: 16300724BACKGROUND
  • 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.

    BACKGROUND

Limitations and Caveats

No limitations or caveats to declare

Results Point of Contact

Title
Keisha C. Gobin, MA
Organization
York University

Study Officials

  • Keisha C Gobin, BA

    York University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 24, 2018

Study Start

October 3, 2018

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

May 11, 2021

Results First Posted

April 5, 2021

Record last verified: 2021-04

Locations