NCT06367764 · Stanford University
A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations
(LIFESCAPE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
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.
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 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.
Exclusion criteria
- 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
Where
- Palo Alto, California
- San Francisco, California
Collaborators
Patient-Centered Outcomes Research Institute, University of California, San Francisco
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2025 · Source of record for eligibility and locations