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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06088303




Registration number
NCT06088303
Ethics application status
Date submitted
12/10/2023
Date registered
18/10/2023

Titles & IDs
Public title
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Scientific title
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Secondary ID [1] 0 0
1K23MH132815-01A1
Secondary ID [2] 0 0
H-44384
Universal Trial Number (UTN)
Trial acronym
AWARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Disorders, Post-Traumatic 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Adjunctive writing to amplify response and engagement (AWARE)
BEHAVIORAL - Cognitive processing therapy (CPT)
BEHAVIORAL - Prolonged exposure (PE)

Experimental: CPT/PE with AWARE - 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.

Active comparator: CPT/PE TAU - 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.


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.

BEHAVIORAL: 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.

BEHAVIORAL: 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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-provider communication: VR-CoDES (Posttreatment)
Timepoint [1] 0 0
Immediately after ending treatment
Primary outcome [2] 0 0
PTSD: CAPS-5 (Posttreatment)
Timepoint [2] 0 0
Immediately after ending treatment
Primary outcome [3] 0 0
PTSD: CAPS-5 (Follow-up)
Timepoint [3] 0 0
3 months after ending treatment
Primary outcome [4] 0 0
Feasibility assessed by CPT adherence
Timepoint [4] 0 0
Immediately after ending treatment
Primary outcome [5] 0 0
Feasibility assessed by CPT competence
Timepoint [5] 0 0
Immediately after ending treatment
Primary outcome [6] 0 0
Feasibility assessed by PE adherence
Timepoint [6] 0 0
Immediately after ending treatment
Primary outcome [7] 0 0
Feasibility assessed by PE competence
Timepoint [7] 0 0
Immediately after ending treatment
Primary outcome [8] 0 0
Acceptability: Client satisfaction (Mid-treatment)
Timepoint [8] 0 0
After 6 sessions
Primary outcome [9] 0 0
Acceptability: Client satisfaction (Posttreatment)
Timepoint [9] 0 0
Immediately after ending treatment
Primary outcome [10] 0 0
Acceptability: Therapeutic Alliance (Mid-treatment)
Timepoint [10] 0 0
After 6 sessions
Primary outcome [11] 0 0
Acceptability: Therapeutic Alliance (Posttreatment)
Timepoint [11] 0 0
Immediately after ending treatment
Primary outcome [12] 0 0
Treatment Completion
Timepoint [12] 0 0
Immediately after ending treatment
Secondary outcome [1] 0 0
Patient-provider communication: PPIS (Posttreatment)
Timepoint [1] 0 0
Immediately after ending treatment
Secondary outcome [2] 0 0
PTSD: PCL-5 (Posttreatment)
Timepoint [2] 0 0
Immediately after ending treatment
Secondary outcome [3] 0 0
PTSD: PCL-5 (Follow-up)
Timepoint [3] 0 0
3 months after ending treatment
Secondary outcome [4] 0 0
Depression (Posttreatment)
Timepoint [4] 0 0
Immediately after ending treatment
Secondary outcome [5] 0 0
Depression (Follow-Up)
Timepoint [5] 0 0
3 months after ending treatment
Secondary outcome [6] 0 0
Functional impairment (Posttreatment)
Timepoint [6] 0 0
Immediately after ending treatment
Secondary outcome [7] 0 0
Functional impairment (Follow-up)
Timepoint [7] 0 0
3 months after ending treatment

Eligibility
Key inclusion criteria
* Diagnosis of PTSD
* Stable on psychiatric medications for at least 4 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Boston University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Alpert, PhD
Address 0 0
National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elizabeth Alpert, PhD
Address 0 0
Country 0 0
Phone 0 0
857-364-6190
Fax 0 0
Email 0 0
elizabeth.alpert@va.gov
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06088303