Cognitive Processing Therapy (CPT) Memory Support (MS) Study
- Conditions
- PTSD
- Interventions
- Behavioral: CPTBehavioral: MS
- Registration Number
- NCT05310097
- Lead Sponsor
- Boston University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Processing Therapy + Memory Support (CPT + MS) MS CPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning. Cognitive Processing Therapy (CPT) CPT CPT is a manualized, trauma-focused therapy for PTSD. Treatment consists of psychoeducation on the cognitive model of PTSD, identification of trauma-related stuck points (i.e. dysfunctional beliefs), and cognitive challenging techniques to help participants identify more realistic and adaptive ways of viewing their trauma, themselves, and the world. Cognitive Processing Therapy + Memory Support (CPT + MS) CPT CPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning.
- Primary Outcome Measures
Name Time Method Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R) 12 weeks 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.
Follow-up Memory of therapy content assessed by the Therapy Recall Task 6 months 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.
Feasibility assessed by mean CPT Adherence 12 weeks 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.
Treatment acceptability after Session 1 assessed by the Credibility and Expectancy (CEQ) questionnaire 1 week 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.
Mid-treatment Memory of therapy content assessed by the Therapy Recall Task 6 weeks 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.
Mid-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R) 6 weeks 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.
Post-treatment Memory of therapy content assessed by the Therapy Recall Task 12 weeks 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.
Feasibility assessed by mean CPT Competence 12 weeks 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.
Feasibility assessed by the Memory Support Rating Scale (MSRS) 12 weeks 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.
Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ) 6 weeks 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.
Post-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ) 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task 6 weeks 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.
Post-treatment Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5) Baseline, 12 weeks 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.
Post-treatment Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9) Baseline, 12 weeks 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.
Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task 12 weeks 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.
Post-treatment Skills of Cognitive Therapy (SoCT) - Patient 12 weeks 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.
Follow-up Skills of Cognitive Therapy (SoCT) - Patient 6 months 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.
Follow-up Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5) Baseline, 6 months 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.
Follow-up Change in Memory of Therapy Content assessed by the Generalization Task Baseline, 6 months 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.
Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist 6 weeks 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.
Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Baseline, 12 weeks 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.
Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Baseline, 6 months 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.
Follow-up Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II) Baseline, 6 months 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
Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task Baseline, 6 weeks 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.
Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient 6 weeks 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.
Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist 12 weeks 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.
Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9) Baseline, 6 months 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.
Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task 6 months 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.
Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task Baseline, 12 weeks 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.
Post-treatment Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II) Baseline, 12 weeks 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
Trial Locations
- Locations (1)
VA Boston Healthcare System
🇺🇸Jamaica Plain, Massachusetts, United States