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| ID | Type | Description | Link |
|---|---|---|---|
| P0566840 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of California, San Francisco | OTHER |
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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:
Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Measured by Patient Health Questionnaire (PHQ-9) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator | 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." | Months 0 (baseline), 3, 6, and 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annesa P Flentje, PhD | Contact | 650-497-7112 | lgbtqia_study@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Annesa P Flentje, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
Individual participant data will only be available to the researchers affiliated with this clinical trial. All data are de-identified and stored on a firewall-protected server.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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. |
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| Months 0 (baseline), 3, 6, and 12 |
| Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales | 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. | Months 0 (baseline), 3, 6, and 12 |
| Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) | The 13-item self-report STTS-R comprises two scales (Satisfaction with Therapy and Satisfaction with Therapist), both with documented reliability and validity. | Months 3, 6, and 12 |
| Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions | 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. | Across intervention |
| Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator | 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. | Months 0 (baseline), 3, 6, and 12 |
| UCSF Alliance Health Project | Recruiting | San Francisco | California | 94103 | United States |
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| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |