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

Trial Summary

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.

What data supports the effectiveness of the treatment Cognitive Processing Therapy, CPT, STAIR Narrative Therapy, STAIR Narrative Therapy, Skills Training in Affective and Interpersonal Regulation Narrative Therapy for PTSD in LGBTQIA+ adults?

Research shows that STAIR Narrative Therapy, a part of the treatment, has been beneficial for women with PTSD related to interpersonal violence, suggesting it could help LGBTQIA+ adults with PTSD. Additionally, narrative therapy has shown promise in reducing PTSD symptoms in veterans and Iraqi refugees, indicating its potential effectiveness in diverse populations. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) and related therapies safe for humans?

Cognitive Processing Therapy (CPT) and related therapies like STAIR Narrative Therapy and Narrative Exposure Therapy have been used in various studies for treating PTSD and have shown to be generally safe for participants, with high completion and retention rates in trials. ^{3 5 6 7 8}

How is the treatment for PTSD in LGBTQIA+ adults unique?

The treatment combines Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy, which not only addresses trauma but also focuses on building social support and relationship skills, making it particularly beneficial for LGBTQIA+ individuals who may face unique social challenges and minority stress. ^{4 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Annesa P Flentje, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

I identify as part of the LGBTQ+ community.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

A pilot examination of the use of narrative therapy with individuals diagnosed with PTSD. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Brief narrative exposure therapy for posttraumatic stress in Iraqi refugees: a preliminary randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Open Trial of Trauma-Focused Psychodynamic Psychotherapy for Posttraumatic Stress Disorder Among LGBTQ Individuals. [2023]

5. England 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. [2022]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial comparing narrative exposure therapy with present-centred therapy for older patients with post-traumatic stress disorder. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder among LGBTQ people: a systematic review and meta-analysis. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Addressing Diversity in PTSD Treatment: Clinical Considerations and Guidance for the Treatment of PTSD in LGBTQ Populations. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

An affect-management group for women with posttraumatic stress disorder and histories of childhood sexual abuse. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Case Reports: STAIR for Strengthening Social Support and Relationships Among Veterans With Military Sexual Trauma and PTSD. [2018]