Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

Stress Disorders, Post-Traumatic Clinical Trial

— AWARE  

Official title:

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088303
• Other study ID #: H-44384
• Secondary ID: 1K23MH132815-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Boston University
• Contact: Elizabeth Alpert, PhD
• Phone: 857-364-6190
• Email: elizabeth.alpert[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of PTSD
• Stable on psychiatric medications for at least 4 weeks

Exclusion Criteria:

• 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
• Current trauma-focused treatment
• Significant cognitive impairment that would prevent engagement in assessments and therapy (e.g., advanced dementia, severe traumatic brain injury).

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Adjunctive writing to amplify response and engagement (AWARE)
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)
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)
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.

Locations

Country	Name	City	State
United States	National Center for PTSD at VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after ending treatment
Primary	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.	Immediately after ending treatment
Primary	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.	3 months after ending treatment
Primary	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.	Immediately after ending treatment
Primary	Feasibility assessed by CPT competence	CPT Therapist Adherence and Competence Protocol-Revised - Observer Rating - CPT competence is the skill with which therapists implement CPT protocol elements across therapy sessions, rated from 1-7, with higher scores indicating greater competence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. A score of good (5) or greater on the 1-7 scale indicates high CPT competence, and would be an indicator of feasibility of AWARE.	Immediately after ending treatment
Primary	Feasibility assessed by PE adherence	PE Fidelity Rating Form - Observer Rating - PE adherence is the percentage of PE 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 PE adherence, and would be an indicator of feasibility of AWARE.	Immediately after ending treatment
Primary	Feasibility assessed by PE competence	PE Fidelity Rating Form - Observer Rating - PE competence is the skill with which therapists implement PE protocol elements across therapy sessions, rated from 1-7, with higher scores indicating greater competence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. A score of good (5) or greater on the 1-7 scale indicates high PE competence, and would be an indicator of feasibility of AWARE.	Immediately after ending treatment
Primary	Acceptability: Client satisfaction (Mid-treatment)	Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability.	After 6 sessions
Primary	Acceptability: Client satisfaction (Posttreatment)	Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability.	Immediately after ending treatment
Primary	Acceptability: Therapeutic Alliance (Mid-treatment)	Working Alliance Inventory Short-Revised (WAI-SR) - Self-Report - The WAI-SR has 12 items assessing three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and therapeutic bond. Total scores range from 12-60; higher scores indicate stronger therapeutic alliance/treatment acceptability.	After 6 sessions
Primary	Acceptability: Therapeutic Alliance (Posttreatment)	Working Alliance Inventory Short-Revised (WAI-SR) - Self-Report - The WAI-SR has 12 items assessing three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and therapeutic bond. Total scores range from 12-60; higher scores indicate stronger therapeutic alliance/treatment acceptability.	Immediately after ending treatment
Primary	Treatment Completion	Proportion of patients who completed a full course of the assigned treatment	Immediately after ending treatment
Secondary	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.	Immediately after ending treatment
Secondary	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.	Immediately after ending treatment
Secondary	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.	3 months after ending treatment
Secondary	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.	Immediately after ending treatment
Secondary	Depression (Follow-Up)	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.	3 months after ending treatment
Secondary	Functional impairment (Posttreatment)	World Health Organization Disability Assessment Schedule-II (WHODAS-II) - Self-Report - The WHODAS-II has 36 items assessing disability and functional impairment. Total scores range from 0-144; higher scores indicate greater disability/functional impairment.	Immediately after ending treatment
Secondary	Functional impairment (Follow-up)	World Health Organization Disability Assessment Schedule-II (WHODAS-II) - Self-Report - The WHODAS-II has 36 items assessing disability and functional impairment. Total scores range from 0-144; higher scores indicate greater disability/functional impairment.	3 months after ending treatment