A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations

PTSD Clinical Trial

— LIFESCAPE  

Official title:

LGBTQIA+ Initiative for Empowerment, Support, Coping, and PTSD Education: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367764
• Other study ID #: BPS-2022C3-30535
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Annesa P Flentje, PhD
• Phone: 415-502-4859
• Email: lgbtqia_study[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:

• Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?

• Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?

• Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms?

• Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?

• Do LGBTQIA+ patients complete these treatments?

Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.

Description:

This study will compare two PTSD treatments that are known to work: Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT). PTSD treatments have not been tested among LGBTQIA+ people. The study is trying to learn which treatment(s) work the best for LGBTQIA+ people in real world settings. This study will help guide clinical decision-making and the selection of PTSD treatment by health care organizations, clinicians, and patients based on what works best for LGBTQIA+ people.

The study will investigate which treatments work better in reducing PTSD symptoms among LGBTQIA+ people. The study will identify if minority stress (e.g., experiences of stigma and discrimination) and use of drugs or alcohol will moderate the effects of the interventions on PTSD symptoms. This study is investigating if both treatments improve depression symptoms and improve quality of life, and which treatments patients complete. The study is also examining if these treatments are effective for all individuals in the study, and if the effects of treatment are different among: 1) cisgender sexual minority men, cisgender sexual minority women, gender expansive or non-binary individuals, transgender women, transgender men, 2) participants who live in urban versus rural or suburban areas, and 3) racial and ethnic minority LGBTQIA+ participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. Currently live in California

3. Ability to understand study procedures and to comply with them for the entire length of the study

4. Ability to understand a written informed consent document and the willing to sign it

5. Ability to speak and read English or Spanish

6. Identify as a sexual and/or gender minority

7. Score 33 or higher on the PTSD Checklist-5 (PCL-5)

8. Interest in getting treatment for PTSD

9. Not be in another concurrent psychotherapy treatment (group or individual) for PTSD (psychotherapy treatment for non-PTSD conditions is allowed).

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment

2. Clinically significant impairment which interferes with ability to fully participate in the study (including symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, or other disorders)

3. Active suicidal intent

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Cognitive Processing Therapy
Cognitive Processing Therapy teaches cognitive restructuring skills to help clients change beliefs and process emotions related to a traumatic event or events.
• STAIR Narrative Therapy
STAIR Narrative Therapy teaches coping skills (e.g., for emotional regulation, interpersonal relationships, everyday stress) and includes a narrative trauma-focused component.

Locations

Country	Name	City	State
United States	UCSF Alliance Health Project	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Patient-Centered Outcomes Research Institute, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator	The adapted minority stress subscales of the CARS have been established as a measure of general minority stress. This subscale consists of five items answered on a 6-point scale ranging from "strongly disagree" to "strongly agree."	Months 0 (baseline), 3, 6, and 12
Other	Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator	The ASSIST is a self-report measure of substance use that gives a score ranging from 0-39, with higher scores reflecting greater substance use involvement, and validated cutoff scores for low, moderate, or high risk substance use involvement.	Months 0 (baseline), 3, 6, and 12
Primary	Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a validated measure of self-report DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom, with higher scores indicating greater symptom severity.	Months 0 (baseline), 3, 6, and 12
Secondary	Change in Depression Measured by Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item measure of depression consistent with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. The self-report rating scale is 0-3 for each symptom, with higher scores indicating greater symptom severity. PHQ-9 has demonstrated good psychometric properties including criterion, construct, and external validity, and sensitivity (88%) and specificity (88%) for major depressive disorder.	Months 0 (baseline), 3, 6, and 12
Secondary	Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales	The self-report 26-item WHOQOL-BREF was multi-nationally developed to assess QOL related to physical health, psychological well-being, social relationships, and environment. The Social Relationships scale assesses facets of quality of life related to personal relationships, social support, and sexual activity. The Environment scale assesses facets related to quality of life including physical safety and security, accessibility and quality of health and social care, and participation in social and leisure opportunities.	Months 0 (baseline), 3, 6, and 12
Secondary	Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)	The 13-item self-report STTS-R comprises two scales (Satisfaction with Therapy and Satisfaction with Therapist), both with documented reliability and validity.	Months 3, 6, and 12
Secondary	Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions	Treatment dropout is defined as completion of < 8 sessions, corresponding to the median effective dose. The number of sessions completed will be identified through mandatory session notes completed by clinicians for each study visit.	Across intervention