Recruiting

PTSD Treatments

Sponsor:

Stanford University

Code:

NCT06367764

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy

STAIR Narrative Therapy

Study Details

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

Study ID

NCT06367764

Start date

Aug 1, 2024

Status verified date

Apr, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

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.

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.

Primary outcome measure

  • Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Months 0 (baseline), 3, 6, and 12 ]

Central Contacts and Locations

Central contacts

Annesa P Flentje, PhD

650-497-7112lgbtqia_study@ucsf.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Annesa Flentje, PhD

415-502-4859lgbtqia_study@ucsf.edu

UCSF Alliance Health Project

Recruiting

San Francisco, California, United States, 94103

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-04-24.