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

Depression Clinical Trial

— Project LEAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751020
• Other study ID #: 1512016952
• Secondary ID: 1R21MH113860-01
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: August 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 27, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• HIV
• Minority Stress
• Substance Abuse
• Substance-Related Disorders
• Suicidality

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United States	East Tennessee State University	Johnson City	Tennessee
United States	Yale University	New Haven	Connecticut
United States	College of the Holy Cross	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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	Self Injury.	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? Reported are the frequency of self-harm behaviors/self-injury reported by participants. Original title: "Change in Self Injury".	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Rumination	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 5 items are summed; total scores range from 5-20, with higher scores indicating greater brooding and rumination (related to depression) in an individual.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Perceived Support	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.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Hopelessness	Hopelessness will be measured using the Beck Hopelessness Scale (BHS). The BHS is a 20-item dichotomous scale ("No" = 0, "Yes" = 1). Items 1, 3, 5, 6, 8, 10, 13, 15 and 19 are reverse-scored. The total score is out of 20, where 20 would be the highest score and considered a negative indicator of hopelessness.	Baseline, Post Intervention, 3 Months
Secondary	Lesbian, Gay, Bisexual (LGB) Identity	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 summed scores have a range of 4-28 and the higher score would indicate a stong agreement (positive) with the centrality of one's LGB identity.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Cortisol	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.	1 and 4 months post baseline.
Secondary	Change in Stress	Stress will be assessed using the Perceived Stress Scale (PSS). Participants were asked to respond to the 14-item version. Participants respond to each item on a 0-4 scale and scores are obtained by reversing responses to the 7 positively stated items (items 4,5,6,7,9,10, & 13), and then summing across all scale items. Range = 0-56. Higher scores indicating higher perceived stress.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Impulsiveness Total Score	Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS). The BIS 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 where the range is 30-120. The highest score indicates the greatest the level of impulsiveness.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Impulsiveness- Attentional	Impulsiveness will be assessed using the Barratt Impulsiveness Scale (BIS). The BIS 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). The attentional scale has a range of 8-32, the greater the value, the greater the level of attentional impulsiveness.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Impulsiveness- Motor	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). The motor scale has a range of 11-44, the greater the value, the greater the level of motor impulsiveness.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Impulsiveness- Non-Planning	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). The non-planning scale has a range of 11-44, the greater the value, the greater the level of non-planning impulsiveness.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Risk Taking	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.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Minority Stress (Rejection)	To assess rejection as a form of minority stress, the Gay-Related Rejection Sensitivity Scale (GRRS) will be used.The Gay-related rejection sensitivity scale was adapted for this study to be gender-inclusive and has 12 items. Scale range 1-36, where higher scores indicate greater rejection sensitivity based on one's sexual orientation (worse outcome).	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Parental Attitudes	The participant's perception of their parent's attitudes towards their sexual orientation are assessed using the Parental Attitudes Toward Child's Sexual Orientation. This tool has 4 items- 2 that deal with mother/parent 1/closest female guardian, 2 that deal with father/parent 2/closest male guardian. The second item for each parent asks about their attitude towards the respondent's sexual orientation on a scale from 1 (completely tolerant and accepting) to 7 (completely hostile and rejecting). Scores for maternal and paternal attitude should be averaged for each participant. The score has a range from 1-7, where higher scores indicate greater rejection from parents (worse outcome).	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Outness	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 score is obtained by averaging the 11 items for a score range of 0-7, where higher scores indicate more openness about respondents' sexual orientation in different domains of their lives/different people. 0 indicates that an item does not apply/ there is no such group of people/person in the respondents' life. A score of 7 would indicate that one is completely open or "out" with respect to sexual orientation.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Internalized Homophobia	Internalized homophobia in participants will be assessed using the Internalized Homophobia Scale (IHS). The IHS score is obtained by averaging the scores across the 9 items (rather than summing). Range is 1-4, with higher scores indicating higher internalized stigma related to one's sexual orientation.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Discrimination - 9 Items (Part 1)	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 scale has a summed total score ranging from 9-54, higher scores indicate higher discrimination. The higher the score, the greater the feeling that one is discriminated against for one's sexual orientation.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Discrimination - Item 1 (Part 2)	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 0-3. The lower the score, the less the feeling that one is discriminated against overall for one's sexual orientation.; Item 1: Overall, how much has discrimination based on your sexual orientation interfered with you having a full and productive life?	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Discrimination - Item 2 (Part 2)	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 0-3. The lower the score, the less the feeling that one is discriminated against overall for one's sexual orientation.; Item 2: Overall, how much harder has your life been because of discrimination based on your sexual orientation?	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Victimization	Feelings of victimization are captured using the LGBT Victimization Experiences measure. This questionnaire consists of 10 items. The LGBT victimization scale is rated on a 0 "Never" to 3 "3+ times" scale with a total score range 0-30. 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.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Religious Affiliation	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.	Baseline, Post Intervention (day 5), and 3 Months.
Secondary	Change in Religious Strain	Religious Strain Scale total score obtained by reverse scoring items 1-7 and then summing across the 20 items (range 0-60), higher scores indicate greater religious strain.	Baseline, Post Intervention (day 5), and 3 Months.