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NCT Number: NCT06367764

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

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.

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Key information

Conditions

PTSD Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions

    Time frame: 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.

Other outcomes

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

    Time frame: Months 0 (baseline), 3, 6, and 12

    The adapted minority stress subscales of the CARS have been established as a measure of general minority stress. This subscale consists of five items answered on a 6-point scale ranging from "strongly disagree" to "strongly agree."

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

    Time frame: Months 0 (baseline), 3, 6, and 12

    The ASSIST is a self-report measure of substance use that gives a score ranging from 0-39, with higher scores reflecting greater substance use involvement, and validated cutoff scores for low, moderate, or high risk substance use involvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Annesa P Flentje, PhD

CONTACT

[email protected]

650-497-7112

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of California, San Francisco

Registry information

Official study title

LGBTQIA+ Initiative for Empowerment, Support, Coping, and PTSD Education: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations

Acronym: LIFESCAPE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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