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

Not Applicable

Recruiting

• Conditions: PTSD
• Interventions: Behavioral: Cognitive Processing Therapy; Behavioral: STAIR Narrative Therapy

• Registration Number: NCT06367764
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Processing Therapy	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.
STAIR Narrative Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)	Months 0 (baseline), 3, 6, and 12	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)	Months 3, 6, and 12	The 13-item self-report STTS-R comprises two scales (Satisfaction with Therapy and Satisfaction with Therapist), both with documented reliability and validity.
Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales	Months 0 (baseline), 3, 6, and 12	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.
Change in Depression Measured by Patient Health Questionnaire (PHQ-9)	Months 0 (baseline), 3, 6, and 12	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.
Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions	Across intervention	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.

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Palo Alto, California, United States

UCSF Alliance Health Project; 🇺🇸 San Francisco, California, United States