Depression, AnxietyNCT03980873
Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach
A study testing ESTEEM (Effective Sikills to Empower Effective Men) in people with Depression, Anxiety and Alcohol Abuse, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Alcohol Abuse, Sexual Compulsivity
- What is being tested?
- ESTEEM (Effective Sikills to Empower Effective Men)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not currently receiving regular mental health services
- not having and addictive disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- ESTEEM (Effective Sikills to Empower Effective Men)
- Keywords
- minority stress, LGB, stigma, cognitive behavioral therapy (CBT)
- Medical subject headings
- Depression, Anxiety Disorders, Alcoholism, Unsafe Sex, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTEEM (Effective Sikills to Empower Effective Men)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: ESTEEM (Effective Sikills to Empower Effective Men) |
| Control | No intervention | Three-month waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
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).
Measured: 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
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).
Measured: baseline (week 0), end of treatment (week 10), and during the maintenance phase
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).
Measured: 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
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).
Measured: baseline (week 0), end of treatment (week 10), and during the maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start20 Sep 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose I. Perez-Fernandez, PhD, University of the Basque Country (UPV/EHU)
- Investigators
- Jose I. Pérez-Fernández, Ph. D, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980873
- Sponsor's protocol ID
- PIF18/233
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To share the study protocol and the clinical study report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy for Young Adult Lesbian, Gay and Bisexual: Transdiagnostic Minority Stress Approach
- ClinicalTrials.gov ID
- NCT03980873
- Acronym / sponsor ID
- PIF18/233
- Conditions
- Depression, Anxiety, Alcohol Abuse, Sexual Compulsivity, Unsafe Sex
- Keywords
- minority stress, LGB, stigma, cognitive behavioral therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ESTEEM (Effective Sikills to Empower Effective Men)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 |
| Control | No intervention | –Three-month waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- not currently receiving regular mental health services
- not having and addictive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Experimental |
Primary outcome
Symptom Assessment-45 Questionnaire from baseline to 16 months
Time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase
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
Time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase
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
Time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase
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 secondary outcomes
Change of Measure of Gay-Related Stress (MOGS) from baseline to 16 months
Time frame: 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
Time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase
Change of Internalized Homophobia Scale (IHP) from baseline to 16 months
Time frame: 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
Time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Yes. To share the study protocol and the clinical study report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose I. Pérez-Fernández, Ph. D principal investigator
University of the Basque Country (UPV/EHU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTEEM (Effective Sikills to Empower Effective Men) in people with Depression, Anxiety and Alcohol Abuse, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Assessment-45 Questionnaire from baseline to 16 months (time frame: baseline (week 0), end of treatment (week 10), and during the maintenance phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.