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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04408469

Enrollment

120

Registered

2020-05-29

Start date

2020-05-31

Completion date

2022-02-18

Last updated

2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LGBTQ, Sexual Behavior

Keywords

on-line intervention

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.

Detailed description

To evaluate the preliminary efficacy of an LGBTQ-affirmative online CBT treatment and whether such an LGBTQ-affirmative focus adds benefit, a 2-arm RCT that would examine (1) whether online EQuIP demonstrates significant mental health improvements compared to self-monitoring of stress and mood, and (2) whether participant baseline LGBTQ-specific stress exposure moderates treatment efficacy, such that participants with the most LGBTQ-specific stress exposure benefit more from online EQuIP than self-monitoring of stress and mood. The primary outcomes are depressive symptoms, anxiety symptoms, substance abuse, sexual risk behavior, and suicidality, all of which disproportionally affect LGBTQ young adults. Secondary outcomes include hypothesized cognitive, affective, and behavioral minority stress mechanisms, such as internalized homophobia, rejection sensitivity, concealment, social isolation, and emotional dysregulation. Participants will be randomized to either self-monitoring control or Online EQuIP group. Self-monitoring control: In this control condition, participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey. This type of self-monitoring has been shown to yield improvement in behavioral health outcomes. Self-reporting LGBTQ stress experiences has also been shown to produce reductions in depression symptoms over time. Participants will record these experiences once per week for 10 weeks. Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Modules contain weekly psychoeducational text and vignettes about minority stress and mental health; brief videos illustrating the CBT skills; and homework exercises that therapists review and provide feedback on. Homework exercises include weekly tracking of stressful situations and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), and exercises related to considering the origins of stress and negative emotions that participants may be experiencing. Therapists provide feedback after each homework assignment, including reviewing each participant's treatment goals as part of the first session's homework. Therapists who support this condition will be instructed to incorporate LGBTQ-specific content and feedback into homework reviews. Therapists will either be postdoctoral fellows in the Pachankis lab or clinical/counseling psychology interns/externs in the Pachankis lab who possess an advanced degree in a mental health field with significant prior experience treating LGBTQ young adults with mental health concerns. Modules were adapted directly from the in-person materials (e.g., therapist manual, participant handouts) used in our previously successful trials of this treatment. A team of six therapists and supervisors of the original in-person treatment adapted the text for the online modules, including realistic vignettes and easy-to-follow skills training. A video production company created accompanying videos with our clinical team's close input. In preparation for this RCT, the online EQuIP treatment was delivered to 14 LGBTQ young adults who meet all eligibility criteria for the full trial. The purpose of this initial test was to ensure acceptability of the treatment content and usability of the technical platform.

Interventions

BEHAVIORALOnline EQuIP

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

BEHAVIORALSelf-monitoring control

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

16 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Distress	Baseline, 4 months, 8 months	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.
Change in Depression	Baseline, 4 months, 8 months	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.
Change in Depression Severity	Baseline, 4 months, 8 months	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.
Change in Anxiety Symptoms	Baseline, 4 months, 8 months	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.
Number of Participants Reporting Any Alcohol Use	Baseline, 4 months, 8 months	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).
Number of Participants Reporting Any Suicidal Ideation	Baseline, 4 months, 8 months	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).
Number of Participants Reporting Any Sexual Risk Behavior	Baseline, 4 months, 8 months	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).

Countries

United States

Participant flow

Recruitment details

Recruitment started in May 2020 and ended in May 2021. Participants for this study were recruited from social media, mobile dating apps, LGBTQ community organizations, and via peer recruitment and referral.

Participants by arm

Arm	Count
Online EQuIP The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.	60
Self-Monitoring 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 control: 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	60
Total	120

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Dismissal due to ineligibility	0	1
Overall Study	Lost to Follow-up	6	9
Overall Study	Withdrawal by Subject	6	1

Baseline characteristics

Characteristic	Self-Monitoring	Online EQuIP	Total
Age, Continuous	22.03 years STANDARD_DEVIATION 3.51	21.83 years STANDARD_DEVIATION 3	21.93 years STANDARD_DEVIATION 3.25
Difficulty Meeting Basic Needs Not very hard	33 Participants	32 Participants	65 Participants
Difficulty Meeting Basic Needs Somewhat hard	18 Participants	26 Participants	44 Participants
Difficulty Meeting Basic Needs Very hard	9 Participants	2 Participants	11 Participants
Education Degree 4-year college degree	16 Participants	16 Participants	32 Participants
Education Degree Advanced graduate school degree	1 Participants	1 Participants	2 Participants
Education Degree Associate's degree	2 Participants	1 Participants	3 Participants
Education Degree High school diploma or GED	9 Participants	4 Participants	13 Participants
Education Degree Less than high school	1 Participants	1 Participants	2 Participants
Education Degree Some college	17 Participants	24 Participants	41 Participants
Education Degree Some graduate school	2 Participants	4 Participants	6 Participants
Education Degree Some high school	12 Participants	9 Participants	21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	11 Participants	22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants	49 Participants	98 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Financial Worry	3.23 score on a scale STANDARD_DEVIATION 1.17	3.23 score on a scale STANDARD_DEVIATION 1.01	3.23 score on a scale STANDARD_DEVIATION 1.09
Race/Ethnicity, Customized Race/ethnicity American Indian or Alaskan Native	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race/ethnicity Asian	8 Participants	12 Participants	20 Participants
Race/Ethnicity, Customized Race/ethnicity Black/African American	2 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized Race/ethnicity Multiracial/Multiple Races	11 Participants	9 Participants	20 Participants
Race/Ethnicity, Customized Race/ethnicity Native Hawaiian/Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race/ethnicity Other	1 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Race/ethnicity White, Hispanic/Latinx	7 Participants	6 Participants	13 Participants
Race/Ethnicity, Customized Race/ethnicity White, Non-Hispanic/Latinx	30 Participants	29 Participants	59 Participants
Sex Assigned at Birth Female	49 Participants	42 Participants	91 Participants
Sex Assigned at Birth Intersex	1 Participants	1 Participants	2 Participants
Sex Assigned at Birth Male	10 Participants	17 Participants	27 Participants
Sex/Gender, Customized Gender identity Cisgender man	5 Participants	10 Participants	15 Participants
Sex/Gender, Customized Gender identity Cisgender woman	29 Participants	22 Participants	51 Participants
Sex/Gender, Customized Gender identity Nonbinary (e.g., genderqueer, agender, gender fluid)	12 Participants	17 Participants	29 Participants
Sex/Gender, Customized Gender identity Other	4 Participants	5 Participants	9 Participants
Sex/Gender, Customized Gender identity Transgender man	8 Participants	3 Participants	11 Participants
Sex/Gender, Customized Gender identity Transgender woman	2 Participants	3 Participants	5 Participants
Sexual Orientation Asexual	3 Participants	3 Participants	6 Participants
Sexual Orientation Bisexual	20 Participants	21 Participants	41 Participants
Sexual Orientation Gay	8 Participants	11 Participants	19 Participants
Sexual Orientation Lesbian	14 Participants	6 Participants	20 Participants
Sexual Orientation Other	1 Participants	4 Participants	5 Participants
Sexual Orientation Pansexual	4 Participants	4 Participants	8 Participants
Sexual Orientation Queer	10 Participants	11 Participants	21 Participants
U.S. Region Midwest	10 Participants	11 Participants	21 Participants
U.S. Region Northeast	13 Participants	9 Participants	22 Participants
U.S. Region South	25 Participants	28 Participants	53 Participants
U.S. Region West	12 Participants	12 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 60	0 / 60
other Total, other adverse events	1 / 60	0 / 60
serious Total, serious adverse events	0 / 60	1 / 60

Outcome results

Primary

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.