Enhanced PTSD Communication Strategies for Post-Traumatic Stress Disorder
(AWARE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University
Disqualifiers: Bipolar, Psychosis, Suicidal ideation, others
Stay on Your Current Meds
No Placebo Group
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.
12345Is 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.
46789How 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.
3451011Eligibility 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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CPT/PE with AWAREExperimental Treatment3 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 TAUActive Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Center for PTSD at VA Boston Healthcare SystemBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Boston UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
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]Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) are first-line treatments for posttraumatic stress disorder (PTSD) and have been disseminated throughout the U.S. Veterans Health Administration. Treatment non-completion is common and lessens clinical effectiveness; however, prior work has failed to identify factors consistently associated with non-completion. Semi-structured interviews were conducted with a national sample of veterans who recently completed (n = 60) or did not complete (n = 66) PE or CPT. Non-completer interviews focused on factors that contributed to veterans' decisions to drop out and efforts undertaken to complete PE/CPT. Completer interviews focused on challenges faced in completing treatment and facilitators of completion. Transcripts were coded using a mixed deductive/inductive approach; constant comparison was used to identify differences between completers and non-completers. Completers and non-completers differed in the extent of treatment-specific therapist support received, therapists' flexibility in treatment delivery, the type of encouragement offered by the care team and social supports, their interpretation of symptom worsening, the perceived impact of treatment on functioning, and the impact of stressors on their treatment engagement. Treatment-specific therapist support, more patient-centered and flexible treatment delivery, leveraging the full care team, and addressing functional concerns are potential targets for PE and CPT engagement interventions.
Pretreatment stabilization increases completion of trauma-focused evidence-based psychotherapies. [2022]Veterans with posttraumatic stress disorder (PTSD) initiate and complete cognitive processing therapy (CPT) and prolonged exposure (PE) at low rates within Veterans Health Administration (VHA) despite substantial dissemination and training. This study investigated how trauma-informed, skills-based treatment ("stabilization") administered before CPT and PE was related to initiation and completion of trauma-focused evidence-based psychotherapies (TF-EBPs).
Comparing written exposure therapy delivered via telehealth to trauma-focused expressive writing in undergraduates: A proof-of-concept trial. [2023]The literature demonstrates that posttraumatic stress disorder (PTSD) rates are estimated to be higher on college campuses compared to lifetime estimates in the general population. Written exposure therapy (WET) is a promising brief intervention for posttraumatic stress symptoms (PTSS) with a growing literature of evidence suggesting efficacy, lower drop-out rates compared to other evidence-based protocols, and long-term treatment gains. This proof-of-concept study examined the efficacy of WET delivered via telehealth compared to expressive writing (EW), the protocol from which WET was derived. The sample included non-treatment-seeking trauma-exposed undergraduate students (N = 33) with elevated PTSS. The results suggest that both WET, g = 1.26, and EW, g = 0.61, were associated with within-person decreases in PTSS. However, reliable change indices indicated that a significantly larger proportion of individuals in the WET condition (61.5%) demonstrated reliable symptom improvement compared to those who received EW (20.0%), g = 0.91. Contrary to our hypotheses, the WET and EW groups did not differ on reliable slopes of change; however, between-group effects were underpowered and should be interpreted with caution. These findings offer preliminary support for WET delivered via telehealth, including for individuals with subthreshold PTSS.
The efficacy of a single imaginal exposure-writing assignment in reducing posttraumatic stress and depressive symptoms: A pilot study. [2020]This online study examined the effects of a single imaginal exposure-writing assignment on posttraumatic stress (PTS) and comorbid depressive symptoms.
Evaluating treatment of posttraumatic stress disorder with cognitive processing therapy and prolonged exposure therapy in a VHA specialty clinic. [2019]This retrospective chart review evaluates the effectiveness of manualized cognitive processing therapy (CPT) protocols (individual CPT, CPT group only, and CPT group and individual combined) and manualized prolonged exposure (PE) therapy on veterans' posttraumatic stress disorder (PTSD) symptoms in one Veterans Health Administration (VHA) specialty clinic. A total of 517 charts were reviewed, and analyses included 178 charts for CPT and 85 charts for PE. Results demonstrated CPT and PE to significantly reduce PTSD Checklist (PCL) scores. However, PE was significantly more effective than CPT after controlling for variables of age, service era, and ethnicity. Additional findings included different outcomes among CPT formats, decreased treatment dropouts for older veterans, and no significant differences in outcome between Hispanic and White veterans. Study limitations and future research directions are discussed.
Brief treatment for PTSD: A non-inferiority trial. [2022]Prior studies have identified several psychosocial treatment approaches as effective for posttraumatic stress disorder (PTSD). Unfortunately, a substantial minority of individuals who receive these treatments drop out prematurely. Moreover, a considerable number of individuals in need of PTSD treatment do not present for treatment due to time constraints and other barriers to care. Thus, there is a need to develop alternative evidence-based PTSD treatments that have lower treatment dropout rates and address current barriers to receiving care. One recently developed PTSD treatment that has demonstrated efficacy and potentially meets these criteria is Written Exposure Therapy (WET), a 5-session treatment protocol that promotes recovery through writing about the trauma event as well as one's thoughts and feelings about it without any assigned homework. In an ongoing randomized controlled trial (RCT) we are investigating whether WET is equally efficacious as Cognitive Processing Therapy (CPT), a treatment that typically requires more therapist training and more therapy sessions. The study sample consists of 126 adults diagnosed with PTSD who are randomly assigned to either WET (n=63) or CPT (n=63). Participants are assessed prior to treatment and 6-, 12-, 24-, 36-, and 60-weeks after the first treatment session. The primary outcome measure is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Given the prevalence of PTSD and the aforementioned limitations of currently available first-line PTSD treatments, the identification of a brief, efficacious treatment that is associated with reduced patient dropout would represent a significant public health development.
Predictors of dropout in cognitive processing therapy for PTSD: An examination of in-session treatment processes. [2023]Dropout rates for treatments for adult posttraumatic stress disorder (PTSD) are high. Process research can reveal client factors during treatment that predict dropout. An observational coding system was used to code client processes in audio-recorded early sessions of cognitive processing therapy (CPT), a gold-standard treatment for PTSD. Data are from a randomized controlled noninferiority trial of CPT and written exposure therapy (WET), with higher rates of dropout in CPT than WET (39.7% vs. 6.4%). Participants in this study were 53 treatment-seeking adults with PTSD who were in the CPT arm of the trial and completed the CAPS-5 at pretreatment and at least one session. Of these, 15 (28.3%) dropped out of CPT early (completing ≤9 sessions) and 38 (71.7%) completed treatment. Sessions were coded with an observational coding system on a four-point scale (0 = absent to 3 = high) for maladaptive trauma-related responses (overgeneralized beliefs, ruminative processing, avoidance), affective engagement (negative emotions, physiological distress), and adaptive processing (cognitive emotional processing). Binary logistic regressions showed that more physiological distress and cognitive emotional processing predicted lower dropout, whereas more avoidance predicted higher dropout. Negative emotion, ruminative processing, and overgeneralization were not significant predictors. These findings highlight potential early indicators of treatment engagement that could be targeted to reduce dropout and perhaps facilitate further therapeutic change.
The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans. [2021]Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.
Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. [2020]Although there are a number of effective treatments for posttraumatic stress disorder (PTSD), there is a need to develop more efficient evidence-based PTSD treatments to address barriers to seeking and receiving treatment. Written exposure therapy (WET) is a potential alternative that is a 5-session treatment without any between-session assignments. WET has demonstrated efficacy, and low treatment dropout rates. However, prior studies with WET have primarily focused on civilian samples. Identifying efficient PTSD treatments for military service members is critical given the high prevalence of PTSD in this population. The current ongoing randomized clinical trial builds upon the existing literature by investigating whether WET is equally efficacious as Cognitive Processing Therapy (CPT) in a sample of 150 active duty military service members diagnosed with PTSD who are randomly assigned to either WET (n = 75) or CPT (n = 75). Participants are assessed at baseline and 10, 20, and 30 weeks after the first treatment session. The primary outcome measure is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Given the prevalence of PTSD and the aforementioned limitations of currently available first-line PTSD treatments, the identification of a brief, efficacious treatment that is associated with reduced patient dropout would represent a significant public health development.
[Courses of affects in an internet-based writing therapy for elderly war trauma survivors. A content analytic approach]. [2021]The proven efficacy of the therapeutic approach of writing therapy for the treatment of post-traumatic stress disorder (PTSD) allows a broadening focus and an examination of therapeutic components as well as the written realisation of these on the word level. Prior content analyses showed that these primary data analyses provided valuable new findings allowing insights into the therapeutic process in addition to questionnaires.
"An Internet-based writing Intervention for PTSD in veterans: A feasibility and pilot effectiveness trial" Correction to Krupnick et al. (2016). [2018]Reports an error in "An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial" by Janice L. Krupnick, Bonnie L. Green, Richard Amdur, Adil Alaoui, Anas Belouali, Erika Roberge, David Cueva, Miguel Roberts, Elizabeth Melnikoff and Mary Ann Dutton (Psychological Trauma: Theory, Research, Practice, and Policy, Advanced Online Publication, Sep 8, 2016, np). In the article, the names of authors Adil Alaoui and Anas Belouali were misspelled as Adil Aloui and Anas Beloui respectively. All versions of this article have been corrected. (The following abstract of the original article appeared in record 2016-43134-001.) Objective: Veterans suffering from posttraumatic stress disorder (PTSD) may avoid or fail to follow through with a full course of face-to-face mental health treatment for a variety of reasons. We conducted a pilot effectiveness trial of an online intervention for veterans with current PTSD to determine the feasibility, safety, and preliminary effectiveness of an online writing intervention (i.e., Warriors Internet Recovery & EDucation [WIRED]) as an adjunct to face-to-face psychotherapy. Method: Veterans (N = 34) who had served in Iraq or Afghanistan with current PTSD subsequent to deployment-related trauma were randomized to Veterans Affairs (VA) mental health treatment as usual (TAU) or to treatment as usual plus the online intervention (TAU + WIRED). All research participants were recruited from the Trauma Services Program, VA Medical Center, Washington, DC. They completed baseline assessments as well as assessments 12 weeks and 24 weeks after the baseline assessment. The online intervention consisted of therapist-guided writing, using principles of prolonged exposure and cognitive therapy. The intervention was adapted from an evidence-based treatment used in The Netherlands and Germany for individuals who had been exposed to nonmilitary traumas. Results: In addition to showing that the online intervention was both feasible to develop and implement, as well as being safe, the results showed preliminary evidence of the effectiveness of the TAU + WIRED intervention in this patient population, with particular evidence in reducing PTSD symptoms of hyperarousal. Conclusion: With minor modifications to enhance the therapeutic alliance, this intervention should be tested in a larger clinical trial to determine whether this method of online intervention might provide another alternative to face-to-face treatment for veterans with PTSD. (PsycINFO Database Record