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

NCT03980873 | Completed

• 1 other identifier: PIF18/233
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety; Alcohol Abuse; Sexual Compulsivity; Unsafe Sex

Keywords

minority stress; LGB; stigma; cognitive behavioral therapy (CBT)

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

• 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).

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

• 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).

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

Secondary Outcomes (4)

• Change of Measure of Gay-Related Stress (MOGS) from baseline to 16 months

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

• Change of Gay-related Rejection Sensitivity Scale (GRSS) from baseline to 16 months

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

• Change of Internalized Homophobia Scale (IHP) from baseline to 16 months

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

• Change of Sexual Orientation Concealment Scale (SOCS) from baseline to 16 months

  baseline (week 0), end of treatment (week 10), and during the maintenance phase

Study Arms (2)

Experimental

EXPERIMENTAL

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

Behavioral: ESTEEM (Effective Sikills to Empower Effective Men)

Control

NO INTERVENTION

Three-month waitlist

Interventions

ESTEEM (Effective Sikills to Empower Effective Men) BEHAVIORAL

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not currently receiving regular mental health services
• not having and addictive disorder

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

Universidad del País Vasco

San Sebastián, Guipuzcoa, 20018, Spain

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Alcoholism; Unsafe Sex; Social Stigma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Sexual Behavior; Social Behavior

Study Officials

• Jose I. Pérez-Fernández, Ph. D

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd. Lecturer of School of Psychology

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: September 20, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2021
• Access Criteria: Researchers

Locations

ES (1)