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

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ClinicalTrials.gov Identifier: NCT03980873
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jose I. Perez-Fernandez, PhD, Basque Country University

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, impulsivity and rumination will be analyzed.

Method: A quasi-experimental design will be used, where the LGB youth (n = 80, 18-35 years) will be assigned to the experimental group (immediate treatment), or to the control group (three-month waitlist). At baseline, 3-month, and 6-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.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Alcohol Abuse Sexual Compulsivity Unsafe Sex Behavioral: ESTEEM (Effective Sikills to Empower Effective Men) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach
Estimated Study Start Date : May 20, 2020
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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


No Intervention: Control
Three-month waitlist



Primary Outcome Measures :
  1. Change of Symptom Checklist-90-Revised (SCL-90-R) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    The SCL-90-R Is an inventory developed to assess the intensity of symptoms inventoried during the last weeks. Each of the 90 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. The reliability data of the dimensions have values between 0.81. and 0.90. The internal consistency coefficients indicate the elements of each dimension are highly homogeneous and the coefficients of reliability and temporal stability of 0.78 to 0.90 with a one week interval in the application.

  2. Change of Sexual Compulsivity Scale (SCS) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    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).

  3. Change of Safer Sex Self-Efficacy Questionnaire (SSSE) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    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).

  4. Change of 90-day Time Line Follow Back (TLFB) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    Is an interview in which the evaluator reviews in a period of 90 days the involvement of the subject in risk behaviors and the use of substances according to the frequency of appearance in the period of time evaluated. It shows adequate indexes of reliability and validity. Each day is coded for heavy alcohol use (5+ drinks during that day), sexual partner type (main, casual), and condom use.


Secondary Outcome Measures :
  1. Change of Measure of Gay-Related Stress (MOGS) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]

    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).


  2. Change of Gay-related Rejection Sensitivity Scale (GRSS) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    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).

  3. Change of Internalized Homophobia Scale (IHP) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    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).

  4. Change of Sexual Orientation Concealment Scale (SOCS) from baseline to 34 weeks [ Time Frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase (weeks 14, 22, and 34) ]
    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).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980873


Contacts
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Contact: Jose I. Pérez-Fernández, Ph. D 34 9430156 joseignacio.perez@ehu.eus
Contact: Karmele Salaberria, Ph. D 34 943015635 mcarmen.salaberria@ehu.eus

Sponsors and Collaborators
Basque Country University
Investigators
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Principal Investigator: Jose I. Pérez-Fernández, Ph. D Basque Country University

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Responsible Party: Jose I. Perez-Fernandez, PhD, Phd. Lecturer of School of Psychology, Basque Country University
ClinicalTrials.gov Identifier: NCT03980873     History of Changes
Other Study ID Numbers: PIF18/233
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To share the study protocol and the clinical study report (CSR)
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 2021
Access Criteria: Researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose I. Perez-Fernandez, PhD, Basque Country University:
minority stress
LGB
stigma
cognitive behavioral therapy (CBT)
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders