Clinical trial NCT03541824: Reducing Suicide Risk Associated With Weight Loss
Official title: Reducing Suicide Risk Associated With Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Self Harm
Weight Loss
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.

Detailed description: The current study was designed as a proof-of-concept study to test the association between weight suppression (WS; difference between one's highest and lowest weight) and non-suicidal self-injury (NSSI). Previous research has found an association between current WS and lifetime NSSI and that this association was mediated by depressive symptoms and drive for thinness. The current study therefore modified an existing online cognitive dissonance-based program (the e-Body Project) using mixed gender content (from the Body Project 4 All scripts) to target posited mediators, i.e., depressive symptoms and weight and shape concerns, in a sample of individuals with WS and engagement in current NSSI.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years old
* At least 5 pounds weight suppression
* Engaged in non-suicidal self-injury at least once in past month

Exclusion Criteria:

* Indicated being "sure" of suicide attempt on eligibility screener
* Live outside of the United States
* Currently pregnant

Primary outcomes:
measure: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary outcomes:
measure: Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
measure: Change from baseline on the "Body Esteem Scale: Weight" subscale at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
measure: Change from baseline on the "Body Esteem Scale: Attribution" subscale at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
measure: Change from baseline on the Beck Depression Inventory II at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
measure: Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
measure: Change from baseline on the Positive and Negative Affect Schedule at follow-up
timeFrame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Other outcomes:
Locations:
Study officials:
affiliation: Florida State University
name: Pamela Keel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.