Cognitive Processing Therapy (CPT) Memory Support (MS) Study

PTSD Clinical Trial

Official title:

Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310097
• Other study ID #: H-42343
• Secondary ID: 1K23MH129878-01
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Boston University
• Contact: Joseph Carpenter, PhD MA
• Phone: 617-435-5319
• Email: jcarpen[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD.

The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• For potential participants on psychiatric medication, dose must be stable for the past four weeks.

• Veteran status

Exclusion Criteria:

• Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder

• Active suicidal or homicidal ideation with plan or intent

• Current moderate or severe substance use disorder, as defined by DSM-5 [i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present]

• Prior receipt of CPT or concurrent therapy for PTSD

• Significant cognitive impairment as indicated by a score <10th percentile on the Montreal Cognitive Assessment

• History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration/ Department of Defense (VA/DOD) guidelines

• High verbal memory ability, as indicated by a score >1 standard deviation (SD) above the population mean on the California Verbal Learning Test® Third Edition (CVLT-3) immediate recall task

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• CPT
CPT will be delivered over the course of 12 one-hour weekly sessions (maximum of 18 weeks to complete treatment). Participants will have the option of receiving CPT in-person or via videoconferencing.
• MS
The MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Jamaica Plain	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH), VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-treatment Change in cognitive complaints assessed by the Cognitive Self-Report Questionnaire - Cognitive subscale (CSRQ-C)	The CSRQ-C is a 10-item self-report questionnaire assessing various cognitive complaints, including memory difficulties. Scores range from 10-50, with higher scores indicating greater cognitive complaints.	Baseline, 12 weeks
Other	Follow-up Change in cognitive complaints assessed by the Cognitive Self-Report Questionnaire - Cognitive subscale (CSRQ-C)	The CSRQ-C is a 10-item self-report questionnaire assessing various cognitive complaints, including memory difficulties. Scores range from 10-50, with higher scores indicating greater cognitive complaints.	Baseline, 6 months
Other	Post-treatment Change in PTSD-related cognitions assessed by the Posttraumatic Cognitions Inventory - 9-item (PTCI-9)	The PTCI-9 is a 9-item self-report questionnaire assessing maladaptive beliefs that can occur following trauma. Scores range from 9 to 63, with greater scores indicating stronger maladaptive cognitions.	Baseline, 12 weeks
Other	Follow-up Change in PTSD-related cognitions assessed by the Posttraumatic Cognitions Inventory - 9-item (PTCI-9)	The PTCI-9 is a 9-item self-report questionnaire assessing maladaptive beliefs that can occur following trauma. Scores range from 9 to 63, with greater scores indicating stronger maladaptive cognitions.	Baseline, 6 months
Other	Post-treatment Change in PTSD-related coping self-efficacy assessed by the Trauma Coping Self Efficacy Scale (CSE-T)	The CSE-T is a 9-item self-report measure assessing perceived ability to cope with challenges following a traumatic event. Scores range from 9 to 63, with higher scores indicating greater coping self-efficacy	Baseline, 12 weeks
Other	Follow-up Change in PTSD-related coping self-efficacy assessed by the Trauma Coping Self Efficacy Scale (CSE-T)	The CSE-T is a 9-item self-report measure assessing perceived ability to cope with challenges following a traumatic event. Scores range from 9 to 63, with higher scores indicating greater coping self-efficacy	Baseline, 6 months
Other	Post-treatment Change in sleep difficulties assessed by the Pittsburgh Sleep Quality Index - Brief (PSQI)	The PSQI-Brief is a 6-item questionnaire, with scores ranging from 0 to 15. Higher scores indicate more difficulty with sleep.	Baseline, 12 weeks
Other	Follow-up Change in sleep difficulties assessed by the Pittsburgh Sleep Quality Index - Brief (PSQI)	The PSQI-Brief is a 6-item questionnaire, with scores ranging from 0 to 15. Higher scores indicate more difficulty with sleep.	Baseline, 6 months
Primary	Mid-treatment Memory of therapy content assessed by the Therapy Recall Task	The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.	6 weeks
Primary	Post-treatment Memory of therapy content assessed by the Therapy Recall Task	The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.	12 weeks
Primary	Follow-up Memory of therapy content assessed by the Therapy Recall Task	The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.	6 months
Primary	Feasibility assessed by mean CPT Adherence	CPT adherence is defined as the portion of CPT protocol elements completed across therapy sessions, rated from 0-100%. This will be assessed via observer ratings of a random selection of 25% of tapes/session recordings from each treatment condition using the CPT Therapist Adherence and Competence Protocol - Revised. Completion of = 90% mean adherence to protocol elements indicates high CPT adherence, and would be an indicator of feasibility of CPT+MS.	12 weeks
Primary	Feasibility assessed by mean CPT Competence	CPT competence will be assessed via observer ratings of a random selection of 25% of tapes/session recordings from each treatment condition of the competence with which CPT protocol elements are delivered, rated from 1 (poor) to 7 (excellent). This will be assessed via observer ratings of a random selection of session recordings using the CPT Therapist Adherence and Competence Protocol - Revised. A mean skill rating of "good" or higher (=5 on a 7-point Likert scale) on protocol elements indicates high CPT competence, and would be an indicator of feasibility of CPT+MS.	12 weeks
Primary	Feasibility assessed by the Memory Support Rating Scale (MSRS)	The Memory Support Rating Scale (MSRS) is an an observer-rated scale used to measure the type and frequency of Memory Support strategies used. A greater number of Memory Support strategies used in the CPT+MS condition compared to CPT will indicate feasibility of CPT+MS. A random selection of 25% of tapes from each treatment condition will be assessed to derive the mean Memory Support strategies used.	12 weeks
Primary	Treatment acceptability after Session 1 assessed by the Credibility and Expectancy (CEQ) questionnaire	The CEQ is a 6-item questionnaire that assesses how credible participants think the treatment they are receiving is and how much they expect to benefit, measured after the initial treatment session. The potential range of scores is 6 to 54 and higher scores indicating greater treatment credibility/acceptability.	1 week
Primary	Mid-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)	The WAI-R is a 12-item self-report questionnaire that measures three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and affective bond with the therapist. The potential range of scores is 12 to 60 and higher scores indicate stronger therapeutic alliance/treatment acceptability.	6 weeks
Primary	Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)	The WAI-R is a 12-item self-report questionnaire that measures three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and affective bond with the therapist. The potential range of scores is 12 to 60 and higher scores indicate stronger therapeutic alliance/treatment acceptability.	12 weeks
Primary	Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)	The CSQ is an 8-item self-report questionnaire that assesses client satisfaction with the treatment they received. The potential range of scores is 8 to 32 and higher scores suggest greater client satisfaction/treatment acceptability.	6 weeks
Primary	Post-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)	The CSQ is an 8-item self-report questionnaire that assesses client satisfaction with the treatment they received. The potential range of scores is 8 to 32 and higher scores suggest greater client satisfaction/treatment acceptability.	12 weeks
Secondary	Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task	The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.	6 weeks
Secondary	Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task	The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.	12 weeks
Secondary	Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task	The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.	6 months
Secondary	Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task	The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.	Baseline, 6 weeks
Secondary	Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task	The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.	Baseline, 12 weeks
Secondary	Follow-up Change in Memory of Therapy Content assessed by the Generalization Task	The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.	Baseline, 6 months
Secondary	Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient	The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.	6 weeks
Secondary	Post-treatment Skills of Cognitive Therapy (SoCT) - Patient	The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.	12 weeks
Secondary	Follow-up Skills of Cognitive Therapy (SoCT) - Patient	The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.	6 months
Secondary	Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist	The SoCT - Therapist is an 8-item measure assessing therapist's perception of their patient's comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.	6 weeks
Secondary	Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist	The SoCT - Therapist is an 8-item measure assessing therapist's perception of their patient's comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.	12 weeks
Secondary	Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	The CAPS-5 is a structured interview that will be used to assess PTSD severity based on the severity and frequency of the 20 DSM-5 symptom criteria of PTSD. Scores range from 0 to 80, with higher scores indicating more severe PTSD.	Baseline, 12 weeks
Secondary	Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	The CAPS-5 is a structured interview that will be used to assess PTSD severity based on the severity and frequency of the 20 DSM-5 symptom criteria of PTSD. Scores range from 0 to 80, with higher scores indicating more severe PTSD.	Baseline, 6 months
Secondary	Post-treatment Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report measure PTSD symptoms. Scores range from 0 to 80, with higher scores indicating more severe PTSD.	Baseline, 12 weeks
Secondary	Follow-up Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report measure PTSD symptoms. Scores range from 0 to 80, with higher scores indicating more severe PTSD.	Baseline, 6 months
Secondary	Post-treatment Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)	The PHQ is a 9-item self-report measure of depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression.	Baseline, 12 weeks
Secondary	Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)	The PHQ is a 9-item self-report measure of depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression.	Baseline, 6 months
Secondary	Post-treatment Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)	The WHODAS-II is a 36-item self-report questionnaire measuring disability and general functioning. Scores range from 0 to 144, with higher scores indicating greater disability/lower functioning	Baseline, 12 weeks
Secondary	Follow-up Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)	The WHODAS-II is a 36-item self-report questionnaire measuring disability and general functioning. Scores range from 0 to 144, with higher scores indicating greater disability/lower functioning	Baseline, 6 months