Enhanced PTSD Communication Strategies for Post-Traumatic Stress Disorder

(AWARE Trial)

Overseen By Elizabeth Alpert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Bipolar, Psychosis, Suicidal ideation, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT/PE as usual or CPT/PE with AWARE. It is expected that 25 participants will be randomized to CPT/PE with AWARE and 25 participants will be randomized to receive CPT/PE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT/PE as usual.

Will I have to stop taking my current medications?

The trial requires that participants have been stable on their psychiatric medications for at least 4 weeks, so you will not need to stop taking your current medications if they are stable.

What data supports the effectiveness of the treatment Enhanced PTSD Communication Strategies for Post-Traumatic Stress Disorder?

Research shows that Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) are effective in reducing PTSD symptoms, with PE being more effective than CPT in some cases. Additionally, written exposure therapy (WET), a form of expressive writing, has shown promise in reducing posttraumatic stress symptoms, suggesting that writing-based interventions like AWARE could be beneficial. ^{1 2 3 4 5}

Is the Enhanced PTSD Communication Strategies treatment safe for humans?

The treatment, which includes methods like Written Exposure Therapy (WET) and Cognitive Processing Therapy (CPT), has been studied for PTSD and shows low dropout rates, suggesting it is generally well-tolerated and safe for participants. ^{4 6 7 8 9}

How is the AWARE treatment for PTSD different from other treatments?

The AWARE treatment is unique because it combines writing therapy with traditional PTSD therapies like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE), aiming to enhance patient engagement and response. This approach leverages the therapeutic benefits of writing, which has shown promise in reducing PTSD symptoms, especially when delivered online, making it a flexible and accessible option for patients. ^{3 4 5 10 11}

Research Team

Elizabeth Alpert, PhD

Principal Investigator

National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry

Eligibility Criteria

This trial is for adults with PTSD who are stable on psychiatric medications for at least a month. It's not suitable for individuals with unstable bipolar disorder, psychosis, severe substance use needing immediate attention, active suicidal or homicidal thoughts, those already in trauma-focused treatment, or with cognitive impairments like advanced dementia.

Inclusion Criteria

I have been diagnosed with PTSD.

I have been on the same psychiatric medications for over a month.

Exclusion Criteria

My bipolar disorder is currently not stable.

I do not have severe memory or thinking problems that would stop me from participating in therapy.

Current psychosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Case Series Phase

CPT or PE with AWARE provided to four adults with PTSD to pilot test and refine AWARE

8-15 weeks

Weekly sessions

Randomized Controlled Trial (RCT) Phase

50 adults with PTSD randomized to receive either CPT/PE as usual or CPT/PE with AWARE

8-15 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Adjunctive writing to amplify response and engagement (AWARE)
• Cognitive processing therapy (CPT)
• Prolonged exposure (PE)

Trial Overview The study tests if an adjunctive writing intervention called AWARE can improve outcomes of two existing PTSD treatments: Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE). Participants will either receive standard CPT/PE or the same therapies supplemented with AWARE to enhance patient-therapist communication.

Participant Groups

Group I: CPT/PE with AWARE Experimental Treatment 3 Interventions

Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) with the adjunctive writing intervention to amplify response and engagement (AWARE). CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted. AWARE will be integrated into the CPT/PE sessions.

Group II: CPT/PE TAU Active Control 2 Interventions

Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) treatment as usual (TAU). CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A study involving 126 veterans (60 completers and 66 non-completers) of Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) for PTSD identified key factors influencing treatment completion, such as the level of therapist support and flexibility in treatment delivery.

Enhancing treatment engagement by providing more personalized therapist support, addressing functional concerns, and leveraging the entire care team could improve completion rates for PE and CPT among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout. Kehle-Forbes, SM., Ackland, PE., Spoont, MR., et al.[2023]

Veterans who received individual stabilization before starting trauma-focused evidence-based psychotherapies (TF-EBPs) had a significantly higher completion rate (93%) compared to those who did not receive stabilization (50%), indicating that individual stabilization enhances treatment adherence.

In contrast, veterans who underwent group-only stabilization had a lower initiation rate of TF-EBPs (10%), suggesting that this type of stabilization may not be as effective in encouraging veterans to start therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment stabilization increases completion of trauma-focused evidence-based psychotherapies. Staudenmeyer, AH., Maxwell, S., Mohlenhoff, B., et al.[2022]

A study involving 33 trauma-exposed undergraduate students found that written exposure therapy (WET) delivered via telehealth significantly reduced posttraumatic stress symptoms (PTSS), with 61.5% of participants showing reliable improvement compared to 20.0% in the expressive writing (EW) group.

Both WET and EW were effective in decreasing PTSS, but WET demonstrated a larger effect size (g = 1.26) compared to EW (g = 0.61), suggesting that WET may be a more effective intervention for individuals with elevated PTSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing written exposure therapy delivered via telehealth to trauma-focused expressive writing in undergraduates: A proof-of-concept trial. Ellis, RA., Darnell, BC., Orcutt, HK.[2023]

In a study of 46 participants with posttraumatic stress (PTS), a single imaginal exposure-writing assignment did not show significant efficacy in reducing PTS or comorbid depressive symptoms compared to other writing and control conditions.

Despite the lack of effectiveness for the imaginal exposure-writing task, both PTS and depressive symptoms decreased over time for all participants, suggesting that other factors may contribute to symptom improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a single imaginal exposure-writing assignment in reducing posttraumatic stress and depressive symptoms: A pilot study. Vinke, YD., Truijens, F., van Polanen Petel, E., et al.[2020]

A review of 517 veteran charts showed that both cognitive processing therapy (CPT) and prolonged exposure (PE) therapy significantly reduced PTSD symptoms, as measured by the PTSD Checklist (PCL) scores.

Prolonged exposure therapy was found to be more effective than cognitive processing therapy after adjusting for factors like age and ethnicity, highlighting its potential as a preferred treatment option for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating treatment of posttraumatic stress disorder with cognitive processing therapy and prolonged exposure therapy in a VHA specialty clinic. Jeffreys, MD., Reinfeld, C., Nair, PV., et al.[2019]

Written Exposure Therapy (WET) is a new 5-session treatment for PTSD that encourages patients to write about their trauma and feelings, potentially leading to lower dropout rates compared to traditional therapies.

In an ongoing study with 126 adults diagnosed with PTSD, WET is being compared to Cognitive Processing Therapy (CPT) to determine if it is equally effective, with assessments occurring at multiple time points after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief treatment for PTSD: A non-inferiority trial. Sloan, DM., Marx, BP., Resick, PA.[2022]

In a study of 53 adults with PTSD undergoing cognitive processing therapy (CPT), dropout rates were significantly higher (39.7%) compared to written exposure therapy (6.4%), indicating a need to address factors influencing treatment retention.

The research identified that higher levels of physiological distress and cognitive emotional processing were associated with lower dropout rates, while avoidance behaviors predicted higher dropout, suggesting that targeting these factors early in treatment could improve engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of dropout in cognitive processing therapy for PTSD: An examination of in-session treatment processes. Shayani, DR., Canale, CA., Sloan, DM., et al.[2023]

A randomized controlled trial will assess the effectiveness of online written exposure therapy compared to imaginal exposure therapy for 300 Veterans with PTSD, aiming to improve access to care.

The study will evaluate whether written exposure therapy is as effective as imaginal exposure while also exploring factors that may influence treatment outcomes, such as trauma-related thoughts and emotion regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. McLean, CP., Miller, ML., Gengler, R., et al.[2021]

Written Exposure Therapy (WET) is being tested in a randomized clinical trial with 150 active duty military service members to see if it is as effective as Cognitive Processing Therapy (CPT) for treating PTSD.

WET is a brief 5-session treatment that has shown low dropout rates and efficacy in previous studies, making it a promising alternative for military personnel who often face barriers to traditional PTSD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Sloan, DM., Marx, BP., Resick, PA., et al.[2020]

A study analyzing therapeutic texts from 51 PTSD patients revealed that writing about trauma exposure led to a significant increase in the use of negative emotional words like fear and depression compared to writing about biographical experiences.

Cognitive restructuring texts showed the highest emotional intensity, containing both negative and positive affective words, indicating that this component of writing therapy may be particularly effective in addressing a range of emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Courses of affects in an internet-based writing therapy for elderly war trauma survivors. A content analytic approach]. Böttche, M., Berth, H., Knaevelsrud, C., et al.[2021]

The online writing intervention, Warriors Internet Recovery & Education (WIRED), was found to be feasible and safe for veterans with PTSD, showing preliminary effectiveness in reducing symptoms, particularly hyperarousal.

In a pilot study involving 34 veterans, the combination of standard mental health treatment with the online intervention indicated potential benefits, suggesting that this approach could serve as a valuable alternative to traditional face-to-face therapy for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"An Internet-based writing Intervention for PTSD in veterans: A feasibility and pilot effectiveness trial" Correction to Krupnick et al. (2016). [2018]

References

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

Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout. [2023]

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

Pretreatment stabilization increases completion of trauma-focused evidence-based psychotherapies. [2022]

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

Comparing written exposure therapy delivered via telehealth to trauma-focused expressive writing in undergraduates: A proof-of-concept trial. [2023]

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

The efficacy of a single imaginal exposure-writing assignment in reducing posttraumatic stress and depressive symptoms: A pilot study. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating treatment of posttraumatic stress disorder with cognitive processing therapy and prolonged exposure therapy in a VHA specialty clinic. [2019]

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

Brief treatment for PTSD: A non-inferiority trial. [2022]

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

Predictors of dropout in cognitive processing therapy for PTSD: An examination of in-session treatment processes. [2023]

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

The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. [2021]

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

Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

[Courses of affects in an internet-based writing therapy for elderly war trauma survivors. A content analytic approach]. [2021]

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

"An Internet-based writing Intervention for PTSD in veterans: A feasibility and pilot effectiveness trial" Correction to Krupnick et al. (2016). [2018]