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Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

ConditionStress Disorders, Post-Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of PTSD

Stable on psychiatric medications for at least 4 weeks

Disqualifiers

Current unstable bipolar disorder

Current psychosis

Current active suicidal or homicidal ideation with intent or plan

Current severe substance use that warrants immediate medical attention

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adjunctive writing to amplify response and engagement (AWARE)

    Behavioral

    AWARE includes two components: 1) patients complete brief writing prompts asking about their experiences in treatment, and 2) therapists review patients' responses and facilitate guided discussion related to patients' experiences during check-ins at the beginning of each session.

  • Cognitive processing therapy (CPT)

    Behavioral

    CPT is a manualized, evidence-based therapy for PTSD typically delivered over the course of 8-15 weekly 60-minute sessions. CPT focuses on helping patients identify trauma-related stuck points (inaccurate and/or unhelpful beliefs) and challenge those beliefs to arrive at healthier, more balanced beliefs about their traumatic experiences, themselves, others, and the world.

  • Prolonged exposure (PE)

    Behavioral

    PE is a manualized, evidence-based therapy for PTSD typically delivered over the course of 8-15 weekly 90-minute sessions. PE focuses on reducing unhelpful avoidance and helping patients process and make sense of their traumatic experiences through in vivo and imaginal exposure to trauma-related reminders and memories.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: CPT/PE with AWAREExperimental treatment 3 interventions
Group B: CPT/PE TAUActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Patient-provider communication: VR-CoDES (Posttreatment)

Verona Coding Definitions of Emotional Sequences (VR-CoDES) - Observational Coding - Used to code patient writing and recordings of each weekly session check-in for 1) patient disclosure of concerns and 2) therapists' responses to patients' concerns. A random selection of 25% of session recordings will be rated. Patients' cues and concerns and providers' responses to patients' cues and concerns are classified into 25 categories, coded as present/absent. Codes will be averaged across all treatment sessions coded.

Time frame
Immediately after ending treatment
2

PTSD: CAPS-5 (Posttreatment)

Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) - Clinician Interview - The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Time frame
Immediately after ending treatment
3

PTSD: CAPS-5 (Follow-up)

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) - Clinician Interview - The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Time frame
3 months after ending treatment
4

Feasibility assessed by CPT adherence

CPT Therapist Adherence and Competence Protocol-Revised - Observer Rating - CPT adherence is the percentage of CPT protocol elements completed across therapy sessions, rated from 0-100%, with a higher percentage indicating greater adherence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. Completion of ≥ 90% mean adherence to protocol elements indicates high CPT adherence, and would be an indicator of feasibility of AWARE.

Time frame
Immediately after ending treatment

Secondary outcomes

1

Patient-provider communication: PPIS (Posttreatment)

Patient-Provider Interaction Scale (PPIS) - Self-Report - The PPIS has 6 items assessing patients' perceptions of patient-provider communication. The PPIS will be collected every session by study staff, and scores will be averaged across sessions. Total scores range from 6-24; higher scores indicate better patient-provider communication.

Time frame
Immediately after ending treatment
2

PTSD: PCL-5 (Posttreatment)

PTSD Checklist for DSM-5 (PCL-5) - Self-Report - The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Time frame
Immediately after ending treatment
3

PTSD: PCL-5 (Follow-up)

PTSD Checklist for DSM-5 (PCL-5) - Self-Report - The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

Time frame
3 months after ending treatment
4

Depression (Posttreatment)

Patient Health Questionnaire (PHQ-9) - Self-Report - The PHQ-9 has 9 items assessing depression symptoms. Total scores range from 0-27; higher scores indicating greater depression severity.

Time frame
Immediately after ending treatment

Other outcomes

Sponsors and contacts

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Boston University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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