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

NCT06367764 | Recruiting

• 2 other identifiers: 79658P0566840
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD

Keywords

PTSD; Therapy; LGBTQ; Depression; Comparative Effectiveness Trial; Substance Use; Minority Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Depression Measured by Patient Health Questionnaire (PHQ-9)

  Months 0 (baseline), 3, 6, and 12

• Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales

  Months 0 (baseline), 3, 6, and 12

• Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)

  Months 3, 6, and 12

• Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions

  Across intervention

Other Outcomes (2)

• Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator

  Months 0 (baseline), 3, 6, and 12

• Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator

  Months 0 (baseline), 3, 6, and 12

Study Arms (2)

Cognitive Processing Therapy

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy

STAIR Narrative Therapy

ACTIVE COMPARATOR

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.

Behavioral: STAIR Narrative Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

Cognitive Processing Therapy teaches cognitive restructuring skills to help clients change beliefs and process emotions related to a traumatic event or events.

Cognitive Processing Therapy

STAIR Narrative Therapy BEHAVIORAL

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

STAIR Narrative Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Currently live in California
• Ability to understand study procedures and to comply with them for the entire length of the study
• Ability to understand a written informed consent document and the willing to sign it
• Ability to speak and read English or Spanish
• Identify as a sexual and/or gender minority
• Score 33 or higher on the PTSD Checklist-5 (PCL-5)
• Interest in getting treatment for PTSD
• Not be in another concurrent psychotherapy treatment (group or individual) for PTSD (psychotherapy treatment for non-PTSD conditions is allowed).
• Able to attend treatment sessions in person in San Francisco or have access to a device that allows for treatment via videoconferencing.

You may not qualify if:

• Contraindication to any study-related procedure or assessment
• Clinically significant impairment which interferes with ability to fully participate in the study (including symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, or other disorders)
• Active suicidal intent

Sponsors & Collaborators

• Stanford University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

UCSF Alliance Health Project

San Francisco, California, 94103, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Study Officials

• Annesa P Flentje, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annesa P Flentje, PhD

CONTACT

650-497-7112; lgbtqia_study@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Stanford Prevention Research Center)

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)