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

NCT ID: NCT06367764

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-06-30

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Processing Therapy

Cognitive Processing Therapy is a \~12 session trauma-focused therapy that teaches cognitive restructuring skills to help clients change beliefs and process emotions related to a specific traumatic event, which can be generalized to other traumatic experiences as well as everyday stressors. After initial psychoeducation and practice with cognitive restructuring skills, patients use skills to identify and challenge maladaptive beliefs about the traumatic event itself as well as those related to five themes thought to be affected by trauma-safety, trust, power, control, esteem, and intimacy.

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

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 is a \~16-session multicomponent therapy that includes a coping skills component (10 sessions) focused on increasing skills in emotion regulation and interpersonal relationships to address day-to-day life stressors and improve functioning, and a trauma-focused component (6 sessions) which reviews a patient-selected series of traumatic experiences in which the meaning of the events is re-appraised particularly regarding sense of self and relationship to others.

Group Type: ACTIVE_COMPARATOR

STAIR Narrative Therapy

Intervention Type: BEHAVIORAL

STAIR Narrative Therapy teaches coping skills (e.g., for emotional regulation, interpersonal relationships, everyday stress) and includes a narrative trauma-focused component.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Annesa Flentje

Professor of Medicine (Stanford Prevention Research Center)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annesa P Flentje, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

UCSF Alliance Health Project

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Annesa P Flentje, PhD

Role: CONTACT

lgbtqia_study@ucsf.edu

650-497-7112

Facility Contacts

Annesa Flentje, PhD

Role: primary

lgbtqia_study@ucsf.edu

415-502-4859

Annesa Flentje, PhD

Role: primary

Other Identifiers

P0566840

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

79658

Identifier Type: -

Identifier Source: org_study_id