Clinical trial NCT06367764: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations
Official title: LGBTQIA+ Initiative for Empowerment, Support, Coping, and PTSD Education: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: PTSD
Therapy
LGBTQ
Depression
Comparative Effectiveness Trial
Substance Use
Minority Stress
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of California, San Francisco
First posted: 2024-04-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).
10. Able to attend treatment sessions in person in San Francisco or have access to a device that allows for treatment via videoconferencing.

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

Primary outcomes:
measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Months 0 (baseline), 3, 6, and 12
Secondary outcomes:
measure: Change in Depression Measured by Patient Health Questionnaire (PHQ-9)
timeFrame: Months 0 (baseline), 3, 6, and 12
measure: Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales
timeFrame: Months 0 (baseline), 3, 6, and 12
measure: Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
timeFrame: Months 3, 6, and 12
measure: Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions
timeFrame: Across intervention
Other outcomes:
measure: Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator
timeFrame: Months 0 (baseline), 3, 6, and 12
measure: Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator
timeFrame: Months 0 (baseline), 3, 6, and 12
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: UCSF Alliance Health Project
state: California
Study officials:
affiliation: Stanford University
name: Annesa P Flentje, PhD
role: PRINCIPAL_INVESTIGATOR
References: