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Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy (CPT MOST)

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified A-B-C: Working with Events, Thoughts, and Feelings
Challenging Questions
Patterns of Problematic Thinking
Challenging Beliefs
Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, Veterans, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The investigators designed the sample to be representative of Veterans with PTSD who are treated in PTSD Clinical Teams (PCTs), with minimal exclusion criteria. PCT clinicians will provide care for those with exclusionary comorbidities or preference for a medication-based approach, as per standard policies and procedures. Inclusion criteria are:

  • score of 33 or above on the PCL-5
  • at least 8 weeks on a stable dose for individuals who are taking psychotropic medication
  • over the age of 18

Exclusion Criteria:

  • active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment)
  • need for detoxification
  • severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can provide informed consent or adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
  • psychosis or unmanaged bipolar disorder
  • previous receipt of CPT in the past year
  • current engagement in trauma-focused psychotherapy (Prolonged Exposure or Cognitive Processing Therapy)

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
  • Cincinnati VA Medical Center, Cincinnati, OHRecruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Arm Description

Core Session 1, Core Session 2, Module Choice, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Final Session

Core Session 1, Core Session 2, Challenging Questions, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session

Core Session 1, Core Session 2, Problematic Patterns, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session

Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session

Core Session 1, Core Session 2, Challenging Beliefs, Final Session

Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session

Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session

Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session

Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session

Outcomes

Primary Outcome Measures

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview used to measure of PTSD severity. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning and improvement in symptoms since a previous CAPS administration. Scoring An index trauma/Criterion A event At least one Criterion B symptom (questions 1-5) At least one Criterion C symptom (questions 6-7) At least two Criterion D symptoms (questions 8-14) At least two Criterion E symptoms (questions 15-20) Both criterion F and G must be met as well for a PTSD diagnosis. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.

Secondary Outcome Measures

PTSD Checklist for DSM-5 (PCL-5) Change
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores of 33 and above indicate a probable diagnosis of PTSD.
Patient Health Questionnaire (PHQ-9) Change
The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression.

Full Information

First Posted
January 21, 2022
Last Updated
July 11, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05220137
Brief Title
Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
Acronym
CPT MOST
Official Title
Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Detailed Description
Background: One third of post-9/11 Veterans in VHA suffer from posttraumatic stress disorder (PTSD), and among those who initiate Cognitive Processing Therapy (CPT), up to 70% drop out before receiving an adequate dose of treatment. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT, so that CPT can be adapted into a briefer format. The long-term goal of this line of research is to adapt, test, and implement brief, evidence-based treatment for Veterans with PTSD. The overall objective of the current application is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life. Significance/Impact: Upon completion of this project, the investigators expect to have produced an empirically-based, brief version of CPT. This contribution is likely to improve clinical practice for Veterans with PTSD by providing the most effective components at an earlier session, thus increasing the overall effectiveness of treatment and mitigating the negative consequences of untreated PTSD, such as lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. Using a highly efficient experimental design, we will identify which of five CPT components contribute meaningfully to reduction in PTSD symptoms. The investigators will test the effectiveness of each component and each two-way interaction between components. Methodology: The MOST is an innovative engineering-inspired framework that uses an optimization trial to assess the performance of individual intervention components within a multicomponent intervention such as CPT. Guided by the MOST framework, the goal of the proposed project is to empirically inform an abbreviated version of CPT via a highly efficient fractional factorial design. Veterans (N = 270) at three VAMCs with clinically significant PTSD symptoms who meet minimal inclusion/exclusion criteria will be randomized to receive two or more CPT components. This design will test the effectiveness of each component and each two-way interaction between components, as measured by PTSD symptom reduction on the Clinician-administered PTSD scale for DSM-5 (CAPS-5) across six months of follow-up. Implementation/Next Steps: Upon completion of these aims, the expected outcome is an adapted, abbreviated version of CPT that consists of the most effective elements of the intervention. The adapted intervention will be primed for a future large scale, fully powered effectiveness trial. The adapted intervention can be easily disseminated through the VA CPT training program and will have a positive impact on the health and wellbeing of Veterans with PTSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Stress Disorders, Post-Traumatic, Veterans, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Every condition in the experiment will begin with two initial core sessions (Rationale/Impact Statement and Working with Events, Thoughts, and Feelings) and end with a final core session. Each participant will then receive between one and five additional weekly sessions, as described below. The following CPT components will be empirically tested in the fractional factorial design: (1) Modified A-B-C, (2) Challenging Questions, (3) Patterns of Problematic Thinking, (4) Challenging Beliefs, and (5) Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy). Each component will be taught in a single session. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. All treatment sequences will end with a final session that consists of final homework review, review of treatment progress, and relapse prevention techniques. In total, participants will receive between 4 and 8 sessions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Module Choice, Final Session
Arm Title
2
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Final Session
Arm Title
3
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Challenging Questions, Final Session
Arm Title
4
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session
Arm Title
5
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Problematic Patterns, Final Session
Arm Title
6
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session
Arm Title
7
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session
Arm Title
8
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session
Arm Title
9
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Challenging Beliefs, Final Session
Arm Title
10
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session
Arm Title
11
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session
Arm Title
12
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session
Arm Title
13
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Arm Title
14
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session
Arm Title
15
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session
Arm Title
16
Arm Type
Active Comparator
Arm Description
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Intervention Type
Behavioral
Intervention Name(s)
Modified A-B-C: Working with Events, Thoughts, and Feelings
Intervention Description
The Modified A-B-C session teaches the Veteran how to draw connections between events, thoughts, and feelings and incorporates preliminary cognitive restructuring to help challenge stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Intervention Type
Behavioral
Intervention Name(s)
Challenging Questions
Intervention Description
The Challenging Questions session teaches the Veteran to question and confront maladaptive self-statements and stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Intervention Type
Behavioral
Intervention Name(s)
Patterns of Problematic Thinking
Intervention Description
The Patterns of Problematic Thinking session teaches the Veteran to identify counterproductive thinking patterns. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Intervention Type
Behavioral
Intervention Name(s)
Challenging Beliefs
Intervention Description
The Challenging Beliefs session teaches the Veteran to generate alternative thoughts based on the outcome of cognitive restructuring. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Intervention Type
Behavioral
Intervention Name(s)
Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)
Intervention Description
The therapist will present the Module options to the Veteran and the Veteran will select one Module to work on. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Primary Outcome Measure Information:
Title
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
Description
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview used to measure of PTSD severity. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning and improvement in symptoms since a previous CAPS administration. Scoring An index trauma/Criterion A event At least one Criterion B symptom (questions 1-5) At least one Criterion C symptom (questions 6-7) At least two Criterion D symptoms (questions 8-14) At least two Criterion E symptoms (questions 15-20) Both criterion F and G must be met as well for a PTSD diagnosis. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
Time Frame
Baseline, 6-week, 3-month, 6-month
Secondary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5) Change
Description
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores of 33 and above indicate a probable diagnosis of PTSD.
Time Frame
Baseline, 6-week, 3-month, 6-month
Title
Patient Health Questionnaire (PHQ-9) Change
Description
The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression.
Time Frame
Baseline, 6-week, 3-month, 6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The investigators designed the sample to be representative of Veterans with PTSD who are treated in PTSD Clinical Teams (PCTs), with minimal exclusion criteria. PCT clinicians will provide care for those with exclusionary comorbidities or preference for a medication-based approach, as per standard policies and procedures. Inclusion criteria are: score of 33 or above on the PCL-5 at least 8 weeks on a stable dose for individuals who are taking psychotropic medication over the age of 18 Exclusion Criteria: active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment) need for detoxification severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can provide informed consent or adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment) psychosis or unmanaged bipolar disorder previous receipt of CPT in the past year current engagement in trauma-focused psychotherapy (Prolonged Exposure or Cognitive Processing Therapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca K Sripada, PhD MS
Phone
(734) 222-7432
Email
rebecca.sripada@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Heather M Walters, MS
Phone
(734) 845-3650
Email
heather.walters@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Kaufman Sripada, PhD MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael P Robertson
Phone
(734) 845-5718
Email
Michael.Robertson6@va.gov
First Name & Middle Initial & Last Name & Degree
Fatima Makki, MPH MSW
Phone
(734) 845-3623
Email
fatima.makki@va.gov
First Name & Middle Initial & Last Name & Degree
Rebecca Kaufman Sripada, PhD MS
Facility Name
Cincinnati VA Medical Center, Cincinnati, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen M Chard, PhD
Phone
513-861-3100
Ext
6741
Email
kathleen.chard@va.gov
First Name & Middle Initial & Last Name & Degree
Jeremi D Eveland
Phone
(513) 861-3100
Ext
6982
Email
Jeremi.Eveland@va.gov
First Name & Middle Initial & Last Name & Degree
Kathleen M Chard, PhD
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika M Roberge, BA
Phone
(801) 582-1565
Email
erika.roberge@va.gov
First Name & Middle Initial & Last Name & Degree
Amber Martinson, PhD
Phone
(801) 582-1565
Email
amber.martinson@va.gov
First Name & Middle Initial & Last Name & Degree
Erika Monique Roberge, BA

12. IPD Sharing Statement

Plan to Share IPD
No

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Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

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