Reducing Suicide Risk Associated With Weight Loss
29. maj 2018 opdateret af: Pamela Keel, Florida State University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
59
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Body Acceptance Program
The Body Acceptance Program (BAP) is the active condition.
Participants engage in an online intervention during which they complete online and offline activities designed to challenge the appearance-ideal.
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The Body Acceptance Program is a mixed-gender modification of the eBody Project, an online intervention in which cognitive dissonance principals are used to reduce eating pathology.
Andre navne:
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Ingen indgriben: Waitlist control
Participants in the waitlist control group completed baseline and follow-up assessments with no intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Self-harm frequency and likelihood
|
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Feelings about one's appearance; scores are summed and range from 0-40, higher scores indicate greater appearance esteem
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Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
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Change from baseline on the "Body Esteem Scale: Weight" subscale at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Feelings about one's weight; scores are summed and range from 0-32, higher scores indicate greater weight esteem
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Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
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Change from baseline on the "Body Esteem Scale: Attribution" subscale at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Feelings about one's characteristics; scores are summed and range from 0-20, higher scores indicate greater self-esteem
|
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
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Change from baseline on the Beck Depression Inventory II at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Depressive symptoms
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Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Assessment of weight and shape concerns
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Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Change from baseline on the Positive and Negative Affect Schedule at follow-up
Tidsramme: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Captures current positive and negative affect
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Pre-assessment and post-assessment (after intervention or two weeks from baseline)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pamela Keel, Ph.D., Florida State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2016
Primær færdiggørelse (Faktiske)
20. marts 2017
Studieafslutning (Faktiske)
20. marts 2017
Datoer for studieregistrering
Først indsendt
3. december 2017
Først indsendt, der opfyldte QC-kriterier
29. maj 2018
Først opslået (Faktiske)
31. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10274002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Participants' responses to measures collected during the study will be shared with the funding body, the Military Suicide Research Consortium, as part of their Core Data Elements project, a centralized database of data from all MSRC funded projects.
All participant responses are deidentified and are uploaded to the MSRC through a secure upload.
IPD-delingstidsramme
Study protocol and informed consent forms will be shared during and after study recruitment.
Participants' responses to measures collected during the study will be shared at the end of participant completion.
IPD-delingsadgangskriterier
Once data is uploaded to the Core Data Element (CDE) project, it may be combined with data from other projects for greater power to conduct statistical analyses, including, but not limited to, regression analyses and scale development.
The following link (https://msrc.fsu.edu/members/request-access-msrc-database)
describes steps that investigators must take in order to access the data.
In addition, the study protocols and consent forms are reviewed and approved by the Department of Defense Human Research Protection Office (HRPO) throughout the study.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .