A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults

NCT04408469 | Completed Results DMC

• 1 other identifier: 2000025803
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to test the efficacy of an online CBT intervention (EQuIP) that addresses the pathways through which minority stress compromises LGBTQ young adults' co-occurring mental (e.g., depression) and behavioral (e.g., substance use, condomless anal sex) health problems. This purpose of this study is to determine if the treatment is efficacious when delivered online and if its efficacy exceeds that of the self-monitoring control.

Conditions

LGBTQ; Sexual Behavior

Keywords

on-line intervention

Outcome Measures

Primary Outcomes (7)

• Change in Distress

  Distress will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item measure that uses a 0-4 rating scale for each item. An overall score of 72 would be the highest possible score on the measure and would indicate an extreme level of overall distress.

  Baseline, 4 months, 8 months

• Change in Depression

  Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). This 20-item measure uses a 0-3 rating (Rarely or none of the time - Most or all of the time) scale and sums across the items with items 3, 11, 14, and 16 reversed. for a minimum score of 0 and a maximum score of 60. Higher scores indicate greater severity of depression. 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.

  Baseline, 4 months, 8 months

• Change in Depression Severity

  Depression severity will be measured using the Overall Depression Severity \& Impairment Scale (ODSIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the severity of depression.

  Baseline, 4 months, 8 months

• Change in Anxiety Symptoms

  Anxiety symptoms will be measured by the Overall Anxiety Severity \& Impairment Scale (OASIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the presence of anxiety symptoms.

  Baseline, 4 months, 8 months

• Number of Participants Reporting Any Alcohol Use

  Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. Any alcohol use over the past 3 months will be measured through the first item of the instrument ("How often, during the last 3 months did you have a drink containing alcohol?") with the creation of a binary variable (1 = any alcohol use, 0 = no alcohol use).

  Baseline, 4 months, 8 months

• Number of Participants Reporting Any Suicidal Ideation

  Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS). Any suicidal ideation was assessed through the first item of this scale ("In the past month, how often have you had thoughts about suicide?") with the creation of a binary variable (1 = any suicidal ideation, 0 = no suicidal ideation).

  Baseline, 4 months, 8 months

• Number of Participants Reporting Any Sexual Risk Behavior

  Sexual risk behavior is defined as: condomless anal or vaginal/frontal sex \[not counting the sole use of prosthetics\] in the absence of PrEP, with any HIV+ partner \[except primary HIV+ partners with a known undetectable viral load\] or status-unknown partner. A binary variable of any sexual risk behavior was constructed from reports of past-90 day sexual behavior (1 = any sexual risk behavior, 0 = no sexual risk behavior).

  Baseline, 4 months, 8 months

Study Arms (2)

Online EQuIP

EXPERIMENTAL

The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.

Behavioral: Online EQuIP

Self-Monitoring

PLACEBO COMPARATOR

Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks

Behavioral: Self-monitoring control

Interventions

Online EQuIP BEHAVIORAL

This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.

Online EQuIP

Self-monitoring control BEHAVIORAL

Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks

Self-Monitoring

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Participant identifies as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• identify as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
• past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff of 2.5 on either the depression subscale or anxiety subscale
• weekly access to internet on a laptop, desktop, or tablet device
• ability to read, write, and speak in English
• provision of informed consent.

You may not qualify if:

• current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive suicidal ideation)
• evidence of active untreated mania, psychosis, or gross cognitive impairment - current enrollment in an intervention study
• current enrollment in intensive mental health treatment (i.e., receiving mental health treatment more than once per month or 8 or more sessions of CBT within the past year.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Dr. Pachankis' Lab

New York, New York, 10010, United States

Location

Related Publications (9)

• Kauer SD, Reid SC, Crooke AH, Khor A, Hearps SJ, Jorm AF, Sanci L, Patton G. Self-monitoring using mobile phones in the early stages of adolescent depression: randomized controlled trial. J Med Internet Res. 2012 Jun 25;14(3):e67. doi: 10.2196/jmir.1858.

  PMID: 22732135 BACKGROUND

• Pachankis JE, McConocha EM, Clark KA, Wang K, Behari K, Fetzner BK, Brisbin CD, Scheer JR, Lehavot K. A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial. J Consult Clin Psychol. 2020 Jul;88(7):613-630. doi: 10.1037/ccp0000508. Epub 2020 May 21.

  PMID: 32437174 BACKGROUND

• Pachankis JE, Hatzenbuehler ML, Rendina HJ, Safren SA, Parsons JT. LGB-affirmative cognitive-behavioral therapy for young adult gay and bisexual men: A randomized controlled trial of a transdiagnostic minority stress approach. J Consult Clin Psychol. 2015 Oct;83(5):875-89. doi: 10.1037/ccp0000037. Epub 2015 Jul 6.

  PMID: 26147563 BACKGROUND

• van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.

  PMID: 24612048 RESULT

• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.

  PMID: 24708078 RESULT

• Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

  PMID: 6622612 RESULT

• Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182.

  PMID: 16688739 RESULT

• Radloff, L. S. (1977). The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401.

  RESULT

• Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

  PMID: 8329970 RESULT

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Danielle Chiaramonte
• Organization: Yale University School of Public Health

danielle.chiaramonte@yale.edu

646-429-9407

Study Officials

• John Pachankis, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: May 31, 2020
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2023-11

Locations

US (1)