Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
Project LEAP
2 other identifiers
interventional
108
1 country
3
Brief Summary
The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Oct 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2017
CompletedFirst Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2019
CompletedResults Posted
Study results publicly available
August 28, 2020
CompletedAugust 28, 2020
August 1, 2020
1.2 years
July 25, 2018
May 20, 2020
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change in Depression.
Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). An overall depression score is computed as the sum of 20 items, with items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A range of 0-60, with higher scores indicating more depressive symptomatology during the past week.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Psychological Distress.
Psychological Distress will be measured using the Brief Symptom Inventory (BSI). The BSI consists of 18 items scored 0-4. Items are averaged to yield a final score of 0-4. The higher the score, the greater the psychological distress.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Anxiety.
Anxiety will be measured using the Beck Anxiety Inventory (BAI). The BAI total score is reported, which is the sum of all 21 items; with no subscales. The range of scores is 0-63, with higher scores indicating higher anxiety.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Suicidality - Suicidal Ideation.
Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS) . Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, …, 0=10). Total scores range from 0 to 50.
Baseline, Post Intervention (day 5), and 3 Months.
Change in Alcohol Use.
Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Each of the questions has a set of responses to choose from, and each response has a score ranging from 0 to 4. All response scores should be added and recorded as "Total". Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence. (A cut-off score of 10 will provide greater specificity but at the expense of sensitivity.) The score range is 0-40. Higher scores indicate greater hazardous drinking.
Baseline, Post Intervention, 3 Months
Change in Drug Use.
The Short Inventory of Problems-Modified for Drug Use (SIP-DU) is a 15-item scale that asks respondents to rate each item on a dichotomous scale ("No" = 0, "Yes" = 1). Total score reported, which is the sum of all items; no subscales: Range 0-15, higher scores indicate greater problems with drug use.
Baseline, Post Intervention (day 5), and 3 Months.
Suicidal Intent
Suicidal intent will be assessed using a single item that asks: Within the last 3 months/past week, have you seriously considered attempting suicide? \[yes/no\] Number of participants who reported suicidal intent is reported. Originally titled "Change in Suicidality - Suicidal Thoughts".
Baseline, Post Intervention (day 5), and 3 Months.
Attempted Suicide
Suicide attempts will be assessed using a single item that asks: Within the last past 3 months/past week, have you actually attempted suicide? \[yes/no\]. Reported are the number of participants who reported that they had attempted suicide. Original title: "Change in Suicidality: Suicide Attempts".
Baseline, Post Intervention (day 5), and 3 Months.
Secondary Outcomes (22)
Self Injury.
Baseline, Post Intervention (day 5), and 3 Months.
Rumination
Baseline, Post Intervention (day 5), and 3 Months.
Perceived Support
Baseline, Post Intervention (day 5), and 3 Months.
Hopelessness
Baseline, Post Intervention, 3 Months
Lesbian, Gay, Bisexual (LGB) Identity
Baseline, Post Intervention (day 5), and 3 Months.
- +17 more secondary outcomes
Study Arms (3)
Expressive Writing (EW)
EXPERIMENTALExpressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.
Self-Affirmation (SA)
EXPERIMENTALSelf-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.
Control
PLACEBO COMPARATORParticipants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.
Interventions
The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered.
The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences.
Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies.
Eligibility Criteria
You may qualify if:
- Self-identify as lesbian, gay, or bisexual
- Live in Washington county, Tennessee (TN), or any of its 6 contiguous counties in northeastern TN
- Have personal Internet access
- Hair at least 2cm in length
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (3)
Yale University
New Haven, Connecticut, 06520, United States
College of the Holy Cross
Worcester, Massachusetts, 01610, United States
East Tennessee State University
Johnson City, Tennessee, 37614, United States
Related Publications (1)
Pachankis JE, Williams SL, Behari K, Job S, McConocha EM, Chaudoir SR. Brief online interventions for LGBTQ young adult mental and behavioral health: A randomized controlled trial in a high-stigma, low-resource context. J Consult Clin Psychol. 2020 May;88(5):429-444. doi: 10.1037/ccp0000497.
PMID: 32271053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Pachankis
- Organization
- Yale University School of Public Health (Social and Behavioral Sciences)
Study Officials
- PRINCIPAL INVESTIGATOR
John Pachankis, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
November 23, 2018
Study Start
October 27, 2017
Primary Completion
January 1, 2019
Study Completion
June 27, 2019
Last Updated
August 28, 2020
Results First Posted
August 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available 12 months after study completion for three years.
- Access Criteria
- Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.
De-identified individual participant data for all primary and secondary outcome measures will be made available.