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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a writing exercise called AWARE can enhance existing PTSD treatments. Researchers will test two common PTSD therapies—cognitive processing therapy (CPT) and prolonged exposure (PE)—with and without AWARE to assess whether it improves patient communication with therapists and treatment outcomes. The trial targets adults with PTSD who have maintained stable psychiatric medication for at least four weeks. Participants will receive either CPT or PE, with or without the AWARE writing task. The goal is to discover if this new approach enhances treatment outcomes. As an unphased trial, this study provides a unique opportunity to explore innovative methods for improving PTSD treatment outcomes.

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.

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

Research has shown that expressive writing, like that used in the AWARE program, is generally safe and well-received by people with PTSD. One study found that while expressive writing did not change PTSD diagnoses or symptoms, patients managed it well. This suggests that adding AWARE, which includes writing tasks to enhance communication between patients and therapists, is unlikely to cause harm.

Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) are both proven and effective treatments for PTSD. Experts widely recommend these treatments as the best available, and they have been safely used by many patients over the years.

Overall, existing evidence supports the safety of all parts of the trial's treatments. Participants can feel confident that these therapies are well-researched and generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they integrate traditional therapies with a fresh approach that could enhance their effectiveness. Unlike the standard cognitive processing therapy (CPT) and prolonged exposure (PE), which rely solely on therapeutic sessions, the AWARE intervention adds a unique writing component designed to boost patient response and engagement. This adjunctive writing element aims to deepen the therapeutic impact by encouraging patients to articulate and process their experiences more thoroughly. By potentially amplifying the effects of CPT and PE, AWARE could lead to more significant improvements in PTSD symptoms, offering a promising advancement in how we approach treatment for this condition.

What evidence suggests that this trial's treatments could be effective for PTSD?

Studies have shown that cognitive processing therapy (CPT) and prolonged exposure (PE) effectively treat PTSD and rank highly in clinical practice guidelines. In this trial, participants will be randomized into different arms to receive either CPT or PE. One arm will include the adjunctive writing intervention, AWARE, which aims to amplify response and engagement. Research suggests that additional methods like AWARE might enhance these therapies. Although AWARE is still being tested, similar writing activities have been safe and well-received by PTSD patients, aiming to increase patient involvement and improve results during therapy. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Alpert, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06088303

Enhancing PTSD Treatment Outcomes by Improving ... The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health ...

2. bu.trialstoday.org bu.trialstoday.org/trial/NCT06088303

Enhancing PTSD Treatment Outcomes by Improving ... The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6711134/

Do adjuvant interventions improve treatment outcome in ... The current systematic review aims to assess whether adjuvant interventions improve outcome among adult PTSD patients receiving TF-PT.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9224304/

The Effectiveness of Behavioral Interventions in Adults with ... This review examined the effectiveness of behavioral interventions for adults with post-traumatic stress disorder (PTSD) triggered by physical injury or ...

5. pure.psu.edu pure.psu.edu/en/publications/expressive-writing-and-post-traumatic-stress-disorder-effects-on-

Expressive writing and post-traumatic stress disorder Results. Expressive writing was acceptable to patients with PTSD and appeared safe to utilize. No changes in PTSD diagnosis or symptoms were observed, but ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845104/

Treatment of Posttraumatic Stress Disorder: A State-of-the- ... This narrative state-of-the-art review paper describes the progress in the understanding and treatment of Posttraumatic Stress Disorder (PTSD).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18230238/

Expressive writing and post-traumatic stress disorder Results: Expressive writing was acceptable to patients with PTSD and appeared safe to utilize. No changes in PTSD diagnosis or symptoms were observed, but ...

8. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1477519/full

Prebiotics as an adjunct therapy for posttraumatic stress ... This study suggests that targeting the intestinal microbiome through prebiotic supplementation could represent a promising avenue for enhancing treatment ...