search
Back to results

Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach

Primary Purpose

Depression, Anxiety, Alcohol Abuse, Sexual Compulsivity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ESTEEM (Effective Sikills to Empower Effective Men)
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety focused on measuring minority stress, LGB, stigma, cognitive behavioral therapy (CBT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA:

  1. being born male and currently identifying as a man; or being born female and currentry identifying as a female
  2. gay, lesbian or bisexual identity
  3. aged 18 to 25

EXCLUSION CRITERIA:

  1. not currently receiving regular mental health services
  2. not having and addictive disorder

Sites / Locations

  • Universidad del País Vasco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

An experimental group. The psychological treatment includes 10 sessions of cognitive-behavioural treatment ESTEEM (Effective Skills to Empower Effective Men) is a 10-session intervention based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders

Three-month waitlist

Outcomes

Primary Outcome Measures

Symptom Assessment-45 Questionnaire from baseline to 16 months
Is an inventory developed to assess the intensity of symptoms inventoried during the last weeks. Each of the 45 items that is integrated in the self-report questionnaire is answered in a likert scale from 0 (nothing) to 4 (a lot), depending on the intensity with which the subject has lived in the last weeks the discomfort that each one explores. It is evaluated and interpreted in function of 10 primary dimensions (somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychotic and diverse symptoms and three global indexes of psychological disorders). The application does not require more than 15 minutes.
Change of Sexual Compulsivity Scale (SCS) from baseline to 16 months
The SCS contains 10 items (e.g., "my desires to have sex have disrupted my daily life"), rated from 1 (not at all like me) to 4 (very much like me). Item responses are summed to derive an overall score (range 10-40). The SCS has high reliability and validity across multiple studies (Hook, Hook, Davis, Worthington, & Penberthy, 2010). A score of 24 or higher is frequently used to distinguish problematic sexual compulsivity (e.g., Grov, Parsons, & Bimbi, 2010; Ventuneac, Rendina, Grov, Mustanski, & Parsons, 2015).
Change of Safer Sex Self-Efficacy Questionnaire (SSSE) from baseline to 16 months
The 13-item SSSE assesses self-efficacy for condom use in various situations (e.g., "When you really need affection," "When your partner says he/she does not want to use a condom") in response to the prompt, "How confident are you that you could avoid having anal sex without a condom?" using a scale ranging from 1 (not at all tempted) to 5 (extremely tempted). The SSSE predicts condomless anal intercourse among men who have sex with men (MSM; Rendina, 2014).

Secondary Outcome Measures

Change of Measure of Gay-Related Stress (MOGS) from baseline to 16 months
The MOGS contains 56 stressors related to being gay, which participants rated in terms of the negative and positive impact each stressor had if it occurred in the past 12 months along a scale ranging from -3 (extremely negative) to 3 (extremely positive). The negative impact of gay-related stress predicts depressive symptoms over-and-above general life stress (Lewis et al., 2003).
Change of Gay-related Rejection Sensitivity Scale (GRSS) from baseline to 16 months
The GRSS assesses the degree to which gay and bisexual men would be anxious about being rejected in each of 14 vignettes because of their sexual orientation, from 1 (very unconcerned) to 6 (very concerned), and the degree to which they would expect such rejection from 1 (very unlikely) to 6 (very likely). Previous uses of this scale have yielded associations with depression, social anxiety, substance use, and sexual compulsivity (Feinstein, Goldfried, & Davila, 2012; Pachan kis et al., 2015).
Change of Internalized Homophobia Scale (IHP) from baseline to 16 months
The IHP assesses how troubled gay and bisexual men are about their sexual identities over the past year. Participants rate nine items using a scale from 1 (never) to 4 (often). The IHP is associated with general mental and sexual health problems in a sample of adult gay men (Meyer, 1995).
Change of Sexual Orientation Concealment Scale (SOCS) from baseline to 16 months
In the SOCS, participants indicate the degree to which they are "out of the closet" to five domains of people: family; gay, lesbian, and bisexual friends; straight friends; co-workers; and health care providers, using a scale from 1 (out to all) to 4 (out to none). The SOCS has shown significant positive associations with internalized homophobia and negative associations with gay community connectedness (Frost & Meyer, 2009).

Full Information

First Posted
June 4, 2019
Last Updated
July 31, 2023
Sponsor
University of the Basque Country (UPV/EHU)
search

1. Study Identification

Unique Protocol Identification Number
NCT03980873
Brief Title
Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach
Official Title
Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: LGB people experience a large number of anxiety and mood disorders, and risk behaviors than heterosexual (Marshall et al., 2011). The evidence points to the importance played by the stress of minorities in the development of such problems (Bränstrom, Hatzenbuehler, Pachankis and Link, 2016). Objective: The present study aims to adapt and analyze the efficacy of the ESTEEM program designed for this population (Burton, Wang and Pachankis, in press) in: 1) the reduction of psychopathological symptoms, abusive alcohol consumption and risky sexual behavior, 2 ) the decrease in the level of stress, anxiety for rejection, internalized homophobia and level of concealment, and finally, 3) the improvement of assertiveness levels. The effect of the variables social support, emotional regulation strategies and rumination will be analyzed. Method: A quasi-experimental design will be used, where the LGB people (n = 63, 18<) will be assigned to the experimental group (immediate treatment), or to the control group (three-month waitlist). At baseline, 3-month, 6-month and 12-month assessments, participants completed self-reports of mental health and minority stress. Results: It is expected that after treatment, LGB people mental health will be improved, as well as, minority stress will be reduced.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Alcohol Abuse, Sexual Compulsivity, Unsafe Sex
Keywords
minority stress, LGB, stigma, cognitive behavioral therapy (CBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
An experimental group. The psychological treatment includes 10 sessions of cognitive-behavioural treatment ESTEEM (Effective Skills to Empower Effective Men) is a 10-session intervention based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders
Arm Title
Control
Arm Type
No Intervention
Arm Description
Three-month waitlist
Intervention Type
Behavioral
Intervention Name(s)
ESTEEM (Effective Sikills to Empower Effective Men)
Intervention Description
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session intervention based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Barlow et al., 2010). Is an individually-delivered cognitive behavioral treatment with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation abilities; reducing maladaptive cognitive, affective, and behavioral avoidance patterns; and improving motivation and self-efficacy for enacting behavior change
Primary Outcome Measure Information:
Title
Symptom Assessment-45 Questionnaire from baseline to 16 months
Description
Is an inventory developed to assess the intensity of symptoms inventoried during the last weeks. Each of the 45 items that is integrated in the self-report questionnaire is answered in a likert scale from 0 (nothing) to 4 (a lot), depending on the intensity with which the subject has lived in the last weeks the discomfort that each one explores. It is evaluated and interpreted in function of 10 primary dimensions (somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychotic and diverse symptoms and three global indexes of psychological disorders). The application does not require more than 15 minutes.
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Title
Change of Sexual Compulsivity Scale (SCS) from baseline to 16 months
Description
The SCS contains 10 items (e.g., "my desires to have sex have disrupted my daily life"), rated from 1 (not at all like me) to 4 (very much like me). Item responses are summed to derive an overall score (range 10-40). The SCS has high reliability and validity across multiple studies (Hook, Hook, Davis, Worthington, & Penberthy, 2010). A score of 24 or higher is frequently used to distinguish problematic sexual compulsivity (e.g., Grov, Parsons, & Bimbi, 2010; Ventuneac, Rendina, Grov, Mustanski, & Parsons, 2015).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Title
Change of Safer Sex Self-Efficacy Questionnaire (SSSE) from baseline to 16 months
Description
The 13-item SSSE assesses self-efficacy for condom use in various situations (e.g., "When you really need affection," "When your partner says he/she does not want to use a condom") in response to the prompt, "How confident are you that you could avoid having anal sex without a condom?" using a scale ranging from 1 (not at all tempted) to 5 (extremely tempted). The SSSE predicts condomless anal intercourse among men who have sex with men (MSM; Rendina, 2014).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Secondary Outcome Measure Information:
Title
Change of Measure of Gay-Related Stress (MOGS) from baseline to 16 months
Description
The MOGS contains 56 stressors related to being gay, which participants rated in terms of the negative and positive impact each stressor had if it occurred in the past 12 months along a scale ranging from -3 (extremely negative) to 3 (extremely positive). The negative impact of gay-related stress predicts depressive symptoms over-and-above general life stress (Lewis et al., 2003).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Title
Change of Gay-related Rejection Sensitivity Scale (GRSS) from baseline to 16 months
Description
The GRSS assesses the degree to which gay and bisexual men would be anxious about being rejected in each of 14 vignettes because of their sexual orientation, from 1 (very unconcerned) to 6 (very concerned), and the degree to which they would expect such rejection from 1 (very unlikely) to 6 (very likely). Previous uses of this scale have yielded associations with depression, social anxiety, substance use, and sexual compulsivity (Feinstein, Goldfried, & Davila, 2012; Pachan kis et al., 2015).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Title
Change of Internalized Homophobia Scale (IHP) from baseline to 16 months
Description
The IHP assesses how troubled gay and bisexual men are about their sexual identities over the past year. Participants rate nine items using a scale from 1 (never) to 4 (often). The IHP is associated with general mental and sexual health problems in a sample of adult gay men (Meyer, 1995).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase
Title
Change of Sexual Orientation Concealment Scale (SOCS) from baseline to 16 months
Description
In the SOCS, participants indicate the degree to which they are "out of the closet" to five domains of people: family; gay, lesbian, and bisexual friends; straight friends; co-workers; and health care providers, using a scale from 1 (out to all) to 4 (out to none). The SOCS has shown significant positive associations with internalized homophobia and negative associations with gay community connectedness (Frost & Meyer, 2009).
Time Frame
baseline (week 0), end of treatment (week 10), and during the maintenance phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: being born male and currently identifying as a man; or being born female and currentry identifying as a female gay, lesbian or bisexual identity minimum age 18 EXCLUSION CRITERIA: not currently receiving regular mental health services not having and addictive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose I. Pérez-Fernández, Ph. D
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad del País Vasco
City
San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
To share the study protocol and the clinical study report (CSR)
IPD Sharing Time Frame
2021
IPD Sharing Access Criteria
Researchers

Learn more about this trial

Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach

We'll reach out to this number within 24 hrs