Narrative Exposure Therapy for PTSD in Homeless Women

Recruiting at 1 trial location

Overseen By Kirsten A Dickins, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Rush University Medical Center

Disqualifiers: Impaired decisional capacity

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

Trial Summary

What is the purpose of this trial?

Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Narrative Exposure Therapy for PTSD in Homeless Women is an effective treatment?

The available research shows that Narrative Exposure Therapy (NET) has been effective in reducing PTSD symptoms in various populations, including refugees and children. A meta-analysis found that NET led to moderate improvements in PTSD symptoms over the midterm and long term. Although the research specifically on homeless women is limited, the general effectiveness of NET in diverse settings suggests it could be beneficial for this group as well. However, the evidence is mixed, and more specific studies on homeless women are needed to confirm its effectiveness. ^{1 2 3 4 5}

What safety data exists for Narrative Exposure Therapy (NET) for PTSD?

The research does not specifically address safety data for NET, but it provides evidence of its efficacy and applicability across various populations, including refugees, children, and trauma survivors. The studies highlight NET's effectiveness in reducing PTSD and depression symptoms, with sustained treatment results. However, the methodological quality of trials and potential small-study effects suggest caution in interpreting these findings. No specific safety concerns are mentioned, but the need for further studies comparing NET with other trauma-focused interventions is noted. ^{2 3 4 6 7}

Is Narrative Exposure Therapy (NET) a promising treatment for PTSD in homeless women?

Yes, Narrative Exposure Therapy (NET) is a promising treatment for PTSD. It has been shown to help people with PTSD from various backgrounds, including refugees and survivors of natural disasters, by reducing symptoms and improving well-being. Studies have found that NET can have long-lasting positive effects. ^{3 5 7 8 9}

Eligibility Criteria

This trial is for women over 18 who are currently or recently homeless, have problematic substance use, and suffer from trauma-related distress. They must have experienced a traumatic event and show signs of PTSD. Women can't join if they don't meet these specific conditions.

Inclusion Criteria

Positive screen on TAPS-1 (reflecting problematic substance use)

I identify as a woman.

Affected by a traumatic life event and trauma-related distress (+Life Events Checklist for DSM-5 Standard [LEC-5] response ≥1 and PTSD Checklist for DSM-5 [PCL-5] score ≥28)

Exclusion Criteria

I am able to understand and decide to participate in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NET+ intervention immediately or after a waitlist period

3 weeks

Weekly sessions

Follow-up

Participants are monitored for PTSD and trauma-related symptoms, substance use behaviors, and other health outcomes

6 weeks

Treatment Details

Interventions

• Immediate Narrative Exposure Therapy (NET)+
• Waitlist + NET+

Trial Overview The study tests Narrative Exposure Therapy (NET+) immediately versus after a waiting period for women with PTSD and substance use disorders. It aims to see how effective NET+ is in reducing the health consequences of untreated trauma among homeless women.

Participant Groups

Group I: Immediate NET+ Experimental Treatment 1 Intervention

Receives NET+ immediately

Group II: Waitlist NET+ Active Control 1 Intervention

Receives NET+ after waitlist

Immediate Narrative Exposure Therapy (NET)+ is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Narrative Exposure Therapy for:

• Post-traumatic stress disorder (PTSD)
• Substance use disorders (SUD)

Approved in United States as Narrative Exposure Therapy for:

• PTSD
• SUD
• Co-morbid PTSD and SUD

Approved in Canada as Narrative Exposure Therapy for:

• PTSD
• SUD
• Trauma-related disorders

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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]

Narrative exposure therapy (NET) shows moderate effectiveness in reducing PTSD symptoms at midterm and long-term follow-ups, based on a meta-analysis of 24 randomized controlled trials involving various trauma types.

While NET significantly decreased PTSD diagnoses in the short term, this effect was not maintained in the long term, highlighting the need for further research to improve the quality of evidence and understand the therapy's long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating narrative exposure therapy for post-traumatic stress disorder and depression symptoms: A meta-analysis of the evidence base. Raghuraman, S., Stuttard, N., Hunt, N.[2021]

Narrative Exposure Therapy (NET) is feasible and effective for refugees with PTSD, as shown by significant reductions in PTSD symptoms and improvements in global functioning among 76 out of 97 participants who completed the treatment.

28% of participants experienced reliable improvement, with some no longer meeting PTSD criteria, indicating that a supportive living environment may enhance the effectiveness of trauma-focused treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of narrative exposure therapy in an outpatient day treatment programme for refugees: improvement in symptoms and global functioning. de la Rie, SM., Smid, GE., van der Aa, N., et al.[2022]

Narrative exposure therapy (NET) has been shown to be an effective and adaptable treatment for PTSD in children, particularly in refugee populations, and can be applied to various complex cases including those with autism, psychotic symptoms, and histories of trauma.

The therapy's flexibility allows it to be modified for different contexts and needs, making it accessible for health professionals to implement with relatively short training, thus improving care for young people with challenging memories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five Applications of Narrative Exposure Therapy for Children and Adolescents Presenting With Post-Traumatic Stress Disorders. Fazel, M., Stratford, HJ., Rowsell, E., et al.[2021]

A study involving 30 adult participants with PTSD showed that both Narrative Exposure Therapy (NET) and its revised version (NET-R) significantly reduced PTSD symptoms and related distress compared to a waiting list group.

NET-R was found to be as effective as the original NET in promoting posttraumatic growth and improving coping and social support among Chinese earthquake survivors, indicating its feasibility and cost-effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting narrative exposure therapy for Chinese earthquake survivors: a pilot randomised controlled feasibility study. Zang, Y., Hunt, N., Cox, T.[2022]

Narrative Exposure Therapy (NET) has shown large effect sizes in reducing PTSD symptoms in trauma survivors, with a post-treatment effect size of 1.18 and a follow-up effect size of 1.37, based on a meta-analysis of 16 randomized controlled trials involving 947 participants.

NET was found to be more effective than non-active comparators and non-trauma-focused active comparators for PTSD, while also demonstrating medium effect sizes for depression, indicating its potential as a viable treatment option for both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of narrative exposure therapy: a review, meta-analysis and meta-regression analysis. Lely, JCG., Smid, GE., Jongedijk, RA., et al.[2020]

Narrative Exposure Therapy (NET) has been shown to significantly reduce PTSD symptoms in severely traumatized individuals, with a large effect size observed in a meta-analysis of 56 studies involving 1370 participants treated with NET compared to 1055 controls.

Long-term benefits of NET are evident, as the therapy demonstrated large effect sizes for PTSD symptom reduction after 6 months or more, while short-term effects were smaller, indicating that NET may provide sustainable improvements in mental health over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analyses of the long-term efficacy of narrative exposure therapy for adults, children and perpetrators. Siehl, S., Robjant, K., Crombach, A.[2021]

Narrative Exposure Therapy (NET) significantly reduced PTSD symptoms, anxiety, and depression among torture survivors in the MENA region, with the most substantial improvement seen in PTSD symptoms, particularly among women.

The study involved 44 Arabic health professionals and showed that after an average treatment duration of three months, there were notable improvements in self-reported health and physical disabilities, although limitations such as lack of a control group and high dropout rates were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of NET on torture survivors in the MENA region. Viller Hansen, AK., Sloth Hansen-Nord, N., Smeir, I., et al.[2019]

In a study of 111 COVID-19 patients with post-traumatic stress symptoms, those who received Narrative Exposure Therapy (NET) showed a significant reduction in PTSD symptoms compared to those who only received standard psychological support.

While NET also improved sleep quality, anxiety, and depression, these improvements were not significantly different from the control group, suggesting that NET specifically targets PTSD effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of narrative exposure therapy on COVID-19 patients with post-traumatic stress symptoms: A randomized controlled trial. Fan, Y., Shi, Y., Zhang, J., et al.[2022]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating narrative exposure therapy for post-traumatic stress disorder and depression symptoms: A meta-analysis of the evidence base. [2021]

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

Feasibility of narrative exposure therapy in an outpatient day treatment programme for refugees: improvement in symptoms and global functioning. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Five Applications of Narrative Exposure Therapy for Children and Adolescents Presenting With Post-Traumatic Stress Disorders. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Adapting narrative exposure therapy for Chinese earthquake survivors: a pilot randomised controlled feasibility study. [2022]

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

The effectiveness of narrative exposure therapy: a review, meta-analysis and meta-regression analysis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analyses of the long-term efficacy of narrative exposure therapy for adults, children and perpetrators. [2021]

8. Denmark pubmed.ncbi.nlm.nih.gov

Impact of NET on torture survivors in the MENA region. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of narrative exposure therapy on COVID-19 patients with post-traumatic stress symptoms: A randomized controlled trial. [2022]