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Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults (Project LEAP)

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ClinicalTrials.gov Identifier: NCT03751020
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Depression Suicidality Substance Abuse HIV Minority Stress Behavioral: Expressive Writing (EW) Intervention Behavioral: Self-Affirmation (SA) Intervention Other: Control Not Applicable

Detailed Description:
This study is considered the third part ("Phase 3") of a larger study where parts one and two were designed to utilize elicitation focus groups to develop effective intervention materials (Phase 1) and then refine the developed materials through structured interviews (Phase 2). Phase 3 will test feasibility and assess early signs of efficacy of writing interventions. To do this, participants will be randomized to one of three arms (one arm will serve as control). Those that choose to participate will be asked to complete outcome measures (depressive symptoms, suicidality, use of alcohol and illicit drugs, HIV risk behavior) and measures of proposed mediators (self-reported and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, identity centrality) at baseline, post-intervention, and three-month follow-up. In addition, structured interviews with 15 intervention participants will be used to refine study procedures as the investigators scale up this intervention for a future randomized controlled trial (RCT).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Expressive Writing (EW)
Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.
Behavioral: Expressive Writing (EW) Intervention
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.

Experimental: Self-Affirmation (SA)
Self-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.
Behavioral: Self-Affirmation (SA) Intervention
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.

Placebo Comparator: Control
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.
Other: Control
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.




Primary Outcome Measures :
  1. Change in depression. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    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 higher score indicates more depressive symptomatology during the past week.

  2. Change in psychological distress. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Psychological Distress will be measured using the Brief Symptom Inventory (BSI). The BSI consists of 18 items scored 0-4. The higher the score, the greater the psychological distress.

  3. Change in Anxiety. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Anxiety will be measured using the Beck Anxiety Inventory (BAI). The BAI is a 21 item instrument where each item is rated 0-3. The greater the score, the greater amount of anxiety.

  4. Change in Suicidality - Suicidal Thoughts. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Suicidal thoughts will be assessed using a single item that asks: Within the last 3 months/past week, have you seriously considered attempting suicide? [yes/no]

  5. Change in Suicidality - Suicide Attempts [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    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]

  6. Change in Suicidality - Suicidal Ideation. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    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.

  7. Change in Self Injury. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Self injury behaviors will be assessed with the item that asks: How many times in the past 3 months/past week have you engaged in self-harm behavior (e.g., cutting, biting, burning, hitting self) with the intent of harming, but not killing, yourself?

  8. Change in Alcohol Use. [ Time Frame: Baseline, Post Intervention, 3 Months ]
    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.)

  9. Change in Drug Use. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Drug use in participants will be assessed using the Short Inventory of Problems-Modified for Drug Use (SIP-DU). The SIP-DU is a 15 item inventory that asks respondents to rate each item on a scale of 0-3. The mean of the 15 items is calculated and the higher the score (a mean of 4 being highest) indicates greater problems with drug use in respondents.

  10. Change in Sexual Behavior- Main Partner. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    The sexual behavior of respondents with their 'main partner(s)' will be assessed using the Sexual Behavior with Main Partner (SB-MP). The SB-MP is a questionnaire that asks 12 questions about sexual behavior where items are not scored, but rather looked at individually.

  11. Change in Sexual Behavior- Casual Partner. [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    The sexual behavior of respondents with their 'casual partner(s)' will be assessed using the Sexual Behavior with Casual Partner (SB-CP). The SB-CP is a questionnaire that asks 15 questions about sexual behavior where items are not scored, but rather looked at individually.


Secondary Outcome Measures :
  1. Health Care Access [ Time Frame: Baseline, Post Intervention, 3 Months ]
    Health care access will be assessed using a questionnaire that consists of 5 questions that are not summed or scored, but rather reported individually.

  2. Rumination [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Rumination will be assessed using the Ruminative Response Scale - Brooding Subscale (RRS). This scale is modified from the original measure where only items 5, 10, 13, 15 and 16 are used. Each item is scored by respondents on a scale of 1 to 4. To get the overall score, the mean of the 5 items is used. The highest score of 4 indicates a high amount of brooding and rumination (related to depression) in an individual.

  3. Perceived Support [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Perceived social support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12 item instrument that uses a scale 1-7 to rate each item. The scoring is done by taking the average of the items- therefore a score of 7 indicates the highest level of perceived social support.

  4. Hopelessness [ Time Frame: Baseline, Post Intervention, 3 Months ]
    Hopelessness will be measured using the Beck Hopelessness Scale (BHS). The BHS is a questionnaire that consists of a list of twenty statements. The statements are read carefully aloud one by one and if the statement describes a participant's attitude for the past week, including today, write 'T' or 'true' or 'F' or 'false'. The total score is out of 20, where 20 would be the highest score and considered a negative indicator of hopelessness.

  5. Lesbian, Gay, Bisexual (LGB) Identity [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    LGB identity will be measured using the 'LGB Identity Centrality' instrument.The measure consists of 4 items that are rated on a scale of 1-7. The highest score is 28 and would indicate a stong agreement (positive) with the centrality of one's LGB identity.

  6. Change in Cortisol [ Time Frame: 1 and 4 months post baseline. ]
    Participants will provide 50-100 hair strands (at least 2 cm in length) to be used to determine levels of stress based on the cortisol levels found in the analyses of the hair provided.

  7. Change in Stress [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Stress will be assessed using the Perceived Stress Scale (PSS). The PSS is a 10 item questionnaire where participants will use a 0-4 rating scale to respond to each item. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. A total score of 40 is the highest marker of perceived stress in a person responding to the PSS.

  8. Change in Impulsiveness [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS-11). The BIS-11 is a 30 item questionnaire that uses a 1-4 rating scale per item. The 30-item self-report questionnaire, can yield a total score, as well as three factors: attentional (6, 5, 9, 11, 20, 24, 26, 28; motor (2, 3, 4, 16, 17, 19, 21, 22, 23, 25, 30); non-planning (1, 7, 8, 10, 12, 13, 14, 15, 18, 27, 29).

  9. Change in Risk Taking [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Risk taking impulse will be assessed using the Columbia Card Task. Participants are presented with 32 face-down cards. Some of these cards are "gain cards" (which add either +10 or +30 points to the participant's total score) and some of these cards are "loss cards" (which subtract either -250 or -750 points from the participant's total score). On each trial, the participant may turn over as many cards as desired until a loss card is encountered or the participant chooses to not turn over any more cards. As a participant turns over more cards, the probability of encountering a loss card increases. Therefore, turning over more cards constitutes greater risk taking.

  10. Change in Minority Stress (Rejection) [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    To assess rejection as a form of minority stress, the Gay-Related Rejection Sensitivity Scale (GRRS) will be used. The questionnaire has 14 items that each ask a question related to anxiety and likelihood. Each of these items (and sub items) are rated using a scale of 1-6. For each item, multiply the anxiety score by the likelihood score to get an individual rejection sensitivity score for each item. Take the average of the 14 individual rejection sensitivity scores.

  11. Change in Parental Attitudes [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    The participant's perception of their parent's attitudes towards their sexual orientation are assessed using the Parental Attitudes Toward Child's Sexual Orientation. Scores for maternal and paternal attitude should be averaged for each participant; for those participants who have dissolved their sexual orientation to only one parent, only the score for that parent's attitude should be used. If participants have not disclosed their sexual orientation to either parent, they should not receive a score for this variable. This tool has 4 items- 2 that deal with father, 2 that deal with mother.

  12. Change in Outness [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Participants openness about one's sexual orientation will be assessed using the Outness Inventory (OI). A respondent is asked to rate how open they are with various people in society (from family to strangers) on an 11 item questionnaire. The scale for responding is 0-7- where 7 indicates that a person is completely open with their sexual orientation status. The scale is summed where a total score of 77 would indicate that one is completely open or "out" with respect to sexual orientation.

  13. Change in Internalized Homophobia [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Internalized homophobia in participants will be assessed using the Internalized Homophobia Scale (IHS). The IHS has versions for either men or women that each consist of 9 items to rate on a scale of 1-4. The higher the score (36 maximum), the greater the presence of internalized homophobia in a person.

  14. Change in Discrimination - 9 Items (Part 1) [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Everyday discrimination experienced by participants will be measured using the Everyday Discrimination - Sexual Orientation (EDSO) Part 1. Part 1 is a 9 item inventory where respondents rate statements on a scale of 1-6. The higher the score, the greater the feeling that one is discriminated against for one's sexual orientation.

  15. Change in Discrimination - 2 Items (Part 2) [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Everyday discrimination experienced by participants will be measured using the Everyday Discrimination - Sexual Orientation (EDSO) Part 2. Part 2 is a 2 item inventory where respondents rate statements on a scale of 1-4. The lower the score, the less the feeling that one is discriminated against overall for one's sexual orientation.

  16. Change in Victimization [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Feelings of victimization are captured using the LGBT Victimization Experiences measure. This questionnaire consists of 10 items that use a 1-4 rating scale. The total score reflects the amount of victimization one has experienced due to being known or thought to be LGBTQ. Higher scores indicate more negative experiences.

  17. Change in Religious Affiliation [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    Tolerance of one's sexual orientation through the lense of one's practiced religion is measured using a single question. Respondents use a 1-7 scale to rate the question "How tolerant is your religion toward your sexual orientation?"- where 7 indicates total rejection and hostility.

  18. Change in Religious Strain [ Time Frame: Baseline, Post Intervention (day 5), and 3 Months. ]
    The strain that one feels due to their religious practices and their sexual orientation will be measured using the Religious Strain Scale (RSS). The RSS is 20 items and respondents rate each item using a 0-3 scale. The strain sub scale is the sum of items 8-13- where a total of 18 (3*6) is the highest score and the highest marker of strain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Failure to meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751020


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Massachusetts
College of the Holy Cross
Worcester, Massachusetts, United States, 01610
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: John Pachankis, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03751020     History of Changes
Other Study ID Numbers: 1512016952
1R21MH113860-01 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Expressive Writing
Minority Stress
Lesbian Gay Bisexual

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders