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DepressionProject LEAPNCT03751020

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

A study testing Expressive Writing (EW) Intervention and Self-Affirmation (SA) Intervention in people with Depression and Suicidality, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Suicidality, Substance Abuse
What is being tested?
Expressive Writing (EW) Intervention and Self-Affirmation (SA) Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
3 sitesUnited States
Study dates
27 Oct 2017to 27 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Failure to meet inclusion criteria

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • East Tennessee State University

    Johnson City, Tennessee, 37614

  • Yale University

    New Haven, Connecticut, 06520

  • College of the Holy Cross

    Worcester, Massachusetts, 01610

Other trials in United States

About this study

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.

Read the 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).

Being tested
Expressive Writing (EW) Intervention, Self-Affirmation (SA) Intervention, Control
Keywords
Expressive Writing, Minority Stress, Lesbian Gay Bisexual
Medical subject headings
Depression, Suicidal Ideation, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive Writing (EW) InterventionBehavioural

    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) InterventionBehavioural

    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.

  • ControlOther

    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.

Study groups in NCT03751020
Study groupRoleWhat they receive
Expressive Writing (EW)ExperimentalExpressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.
Receives: Behavioral: Expressive Writing (EW) Intervention
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.
Receives: Behavioral: Self-Affirmation (SA) Intervention
ControlPlacebo 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  2. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  3. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  4. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  5. 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.

    Measured: Baseline, Post Intervention, 3 Months

  6. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  7. 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".

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  8. 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".

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

Secondary outcomes (22)
  1. 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".

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  2. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  3. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  4. 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.

    Measured: Baseline, Post Intervention, 3 Months

  5. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  6. 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.

    Measured: 1 and 4 months post baseline.

  7. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  8. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  9. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  10. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  11. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  12. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  13. 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).

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  14. 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).

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  15. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  16. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  17. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  18. 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?

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  19. 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?

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  20. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  21. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

  22. 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.

    Measured: Baseline, Post Intervention (day 5), and 3 Months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start27 Oct 2017
  3. Primary completion1 Jan 2019
  4. Study completion27 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03751020
Sponsor's protocol ID
1512016952
Other IDs
1R21MH113860-01
Acronym
Project LEAP
Status last verified
Aug 2020
First submitted
25 Jul 2018
Last updated
28 Aug 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • 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.

    PubMed 32271053

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Writing (EW) Intervention and Self-Affirmation (SA) Intervention in people with Depression and Suicidality, run by Yale University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression. (time frame: Baseline, Post Intervention (day 5), and 3 Months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03751020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.

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