Therapies for PTSD in LGBTQIA+ Adults

(LIFESCAPE Trial)

Recruiting at 1 trial location

Overseen By Belin Marko, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Schizophrenia, Bipolar, Active suicidal intent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 3-4 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapies, Cognitive Processing Therapy and STAIR Narrative Therapy, to evaluate their effectiveness in treating PTSD in LGBTQIA+ adults. The researchers aim to determine if these treatments reduce PTSD symptoms and enhance life quality and mood. They also examine whether stress from stigma and substance use impacts the treatments' success and assess the therapies' satisfaction and effectiveness across different LGBTQIA+ groups. Individuals who identify as LGBTQIA+, reside in California, and have a PTSD diagnosis might be suitable for this trial. Participants will receive one of the therapies and complete assessments before and after treatment. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving PTSD treatments specifically for the LGBTQIA+ community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be in another psychotherapy treatment for PTSD while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy are safe and well-tolerated for people with PTSD. Studies have found that CPT effectively reduces PTSD symptoms and can also help with depression and suicidal thoughts. Its widespread use and testing confirm its safety for many patients.

For STAIR Narrative Therapy, research indicates it is safe and practical for people who have experienced trauma, such as childhood abuse. It helps improve emotional control and social skills, which are important for handling everyday stress.

Both therapies have undergone testing in different groups and are considered safe. They have shown effectiveness in helping people with PTSD without causing major side effects. This suggests they are likely safe options for LGBTQIA+ adults seeking PTSD treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Processing Therapy and STAIR Narrative Therapy for PTSD in LGBTQIA+ adults because they offer unique approaches compared to standard treatments like Prolonged Exposure Therapy or medication. Cognitive Processing Therapy focuses on helping individuals reframe their thoughts and beliefs about traumatic events, which is key for addressing underlying cognitive patterns. Meanwhile, STAIR Narrative Therapy combines skill-building for emotional and interpersonal challenges with a re-examination of traumatic experiences, providing a holistic approach to recovery. These therapies are designed to empower individuals with tools to manage stress and improve relationships, which can be especially beneficial for those in the LGBTQIA+ community facing distinct stressors.

What evidence suggests that this trial's treatments could be effective for PTSD in LGBTQIA+ adults?

This trial will compare Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy for treating PTSD in LGBTQIA+ adults. Research has shown that CPT effectively treats PTSD. On average, people who received CPT outperformed 89% of those who didn't receive active treatment immediately after therapy, and 82% did better at follow-up. This indicates that CPT significantly reduces PTSD symptoms.

Similarly, STAIR Narrative Therapy, another treatment option in this trial, has demonstrated positive results. It helps people manage emotions and improve relationships, reducing daily stress. Studies have shown that STAIR is effective for individuals who have experienced trauma, including those with complex PTSD. Both therapies have strong evidence supporting their ability to improve PTSD symptoms. ^{3 4 6 7 8}

Who Is on the Research Team?

Annesa P Flentje, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for LGBTQIA+ adults with PTSD. It's looking to see if two therapies, STAIR Narrative Therapy and Cognitive Processing Therapy, can reduce PTSD symptoms and improve life quality. Participants must identify as part of the sexual or gender minority community.

Inclusion Criteria

Score 33 or higher on the PTSD Checklist-5 (PCL-5)

I identify as part of the LGBTQ+ community.

Currently live in California

Exclusion Criteria

Active suicidal intent

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Processing Therapy (~12 sessions) or STAIR Narrative Therapy (~16 sessions) to treat PTSD

3-4 months

12-16 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in PTSD symptoms, depression, quality of life, and substance use

12 months

Assessments at months 0, 3, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• STAIR Narrative Therapy

Trial Overview The study compares STAIR Narrative Therapy with Cognitive Processing Therapy in treating PTSD among LGBTQIA+ individuals. It will evaluate symptom reduction, quality of life enhancement, treatment satisfaction, and completion rates within this population.

How Is the Trial Designed?

Group I: Cognitive Processing Therapy Active Control 1 Intervention

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.

Group II: STAIR Narrative Therapy Active Control 1 Intervention

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.

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A pilot study involving 14 veterans with PTSD showed that after 11 to 12 sessions of narrative therapy, 3 participants no longer met the criteria for PTSD, and 7 experienced significant reductions in their symptoms.

The treatment had a low dropout rate of 21.4% and high satisfaction levels among participants, indicating that narrative therapy could be a promising alternative for PTSD treatment, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot examination of the use of narrative therapy with individuals diagnosed with PTSD. Erbes, CR., Stillman, JR., Wieling, E., et al.[2014]

The study is evaluating the effectiveness of STAIR Narrative Therapy for women with PTSD related to interpersonal violence, involving 352 participants across multiple community mental health clinics, making it the first large-scale trial of its kind in these settings.

Participants are randomly assigned to receive either STAIR Narrative Therapy or Treatment As Usual (TAU), with primary outcomes focusing on PTSD symptoms, emotion management, and interpersonal issues, allowing for a flexible treatment approach based on individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial. Cloitre, M., Henn-Haase, C., Herman, JL., et al.[2022]

Military sexual trauma (MST) is linked to high rates of PTSD and significant challenges in social support and relationship functioning among women Veterans, indicating a need for targeted interventions.

The Skills Training in Affective and Interpersonal Regulation (STAIR) intervention shows promise in enhancing social engagement and relationship skills, suggesting it could be beneficial as a standalone treatment or alongside traditional PTSD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Reports: STAIR for Strengthening Social Support and Relationships Among Veterans With Military Sexual Trauma and PTSD. Cloitre, M., Jackson, C., Schmidt, JA.[2018]

A brief version of narrative exposure therapy (brief NET) was tested on 63 Iraqi refugees suffering from posttraumatic stress, showing high treatment completion (95.1%) and retention (98.4%).

Participants receiving brief NET experienced significant improvements in posttraumatic growth (d = 0.83) and well-being (d = 0.54) compared to controls, along with reduced symptoms of posttraumatic stress and depression at 2 months, indicating its potential efficacy as a culturally sensitive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief narrative exposure therapy for posttraumatic stress in Iraqi refugees: a preliminary randomized clinical trial. Hijazi, AM., Lumley, MA., Ziadni, MS., et al.[2022]

In a study involving 33 older adults (aged 55 and over) with PTSD, both Narrative Exposure Therapy (NET) and Present-Centered Therapy (PCT) were found to be safe and effective treatments, with low drop-out rates and no participants leaving due to increased distress.

While PCT showed a medium effect size advantage over NET immediately after treatment, the differences between the two therapies were not significant at follow-up, suggesting that both therapies can be beneficial for older adults with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial comparing narrative exposure therapy with present-centred therapy for older patients with post-traumatic stress disorder. Lely, JCG., Knipscheer, JW., Moerbeek, M., et al.[2020]

Narrative Exposure Therapy (NET) was found to be highly feasible and acceptable for trauma-affected women, showing significant improvements in PTSD symptoms and somatic symptom burden among the 16 participants in the study.

The study suggests that NET can effectively help women with complex PTSD, and participant feedback on enhancing the intervention's acceptability could improve its scalability for broader use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Traumatic Stress with Justice-Impacted Women and Women Experiencing Homelessness: A Pilot Study of Narrative Exposure Therapy. Dickins, KA.[2023]

Trauma-focused psychodynamic psychotherapy (TFPP) was well tolerated by LGBTQ patients with PTSD, with 86% of the 14 participants completing the 24-session treatment, and significant improvements in PTSD symptoms were observed, including a mean decrease of 21.8 points on the CAPS-5 scale.

The treatment led to a 71% clinical response rate and 50% diagnostic remission, with additional improvements in complex PTSD symptoms, anxiety, depression, and psychosocial functioning, indicating TFPP's effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Trial of Trauma-Focused Psychodynamic Psychotherapy for Posttraumatic Stress Disorder Among LGBTQ Individuals. Keefe, JR., Louka, C., Moreno, A., et al.[2023]

LGBTQ individuals are significantly more likely to experience post-traumatic stress disorder (PTSD) compared to heterosexual and cisgender individuals, with an overall odds ratio of 2.20 based on a systematic review of 27 studies involving over 31,000 LGBTQ participants.

Among LGBTQ subgroups, transgender individuals have the highest risk of PTSD (odds ratio of 2.52), highlighting the need for targeted mental health support and preventive strategies for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder among LGBTQ people: a systematic review and meta-analysis. Marchi, M., Travascio, A., Uberti, D., et al.[2023]

LGBTQ individuals experience higher rates of trauma and discrimination, which complicates PTSD treatment and highlights the need for targeted interventions that address both trauma and minority stress.

Current PTSD treatments, such as trauma-focused therapies and medications, have not adequately considered the unique challenges faced by LGBTQ patients, emphasizing the importance of cultural awareness and patient-centered care in mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Diversity in PTSD Treatment: Clinical Considerations and Guidance for the Treatment of PTSD in LGBTQ Populations. Livingston, NA., Berke, D., Scholl, J., et al.[2022]

In a study involving 48 female survivors of childhood sexual abuse with PTSD, those who participated in a 15-week affect-management treatment reported significantly fewer PTSD and dissociation symptoms compared to those in a wait list control group.

The results indicate that affect-management treatment can be an effective addition to standard individual psychotherapy and pharmacotherapy for improving mental health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An affect-management group for women with posttraumatic stress disorder and histories of childhood sexual abuse. Zlotnick, C., Shea, TM., Rosen, K., et al.[2019]

The pilot randomized controlled trial successfully recruited 15 out of 22 referred participants who were homeless and had active PTSD symptoms, demonstrating the feasibility of engaging this vulnerable population in trauma-focused therapy.

Once therapy began, retention was high, with 80% of participants completing all six sessions, indicating that the treatment was acceptable and participants were willing to stay engaged in the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of Narrative Exposure Therapy to treat individuals with PTSD who are homeless or vulnerably housed: a pilot randomized controlled trial. Edgar, NE., Bennett, A., Dunn, NS., et al.[2022]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06367764

A Comparative Effectiveness Study of PTSD Treatments ... This study will compare two PTSD treatments that are known to work: Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT). PTSD treatments have ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... The average CPT-treated participant fared better than 89% of those in inactive control conditions at posttreatment and 82% at follow-up. Results ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922000761

Cognitive Processing Therapy Delivered in 5 Days via ... The patient experienced significant reduction in PTSD symptoms over the course of treatment, dropping below the clinical threshold for PTSD diagnosis by the ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06367764

Effectiveness Study of PTSD Treatments Among Sexual ... This study will compare two PTSD treatments that are known to work: Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT).

5. withpower.com withpower.com/trial/phase-stress-disorders-post-traumatic-4-2024-170ee

Therapies for PTSD in LGBTQIA+ Adults (LIFESCAPE Trial) A pilot study involving 14 veterans with PTSD showed that after 11 to 12 sessions of narrative therapy, 3 participants no longer met the criteria for PTSD, and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

7. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD To date, CPT has been shown to improve common comorbid symptoms and clinical correlates of PTSD such as depression (12,33), suicidal ideation (34), health- ...

8. apa.org apa.org/ptsd-guideline/treatments/cognitive-processing-therapy

Cognitive Processing Therapy (CPT) CPT is a specific type of cognitive behavioral therapy that helps patients learn how to modify and challenge unhelpful beliefs related to the trauma.