Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Boston University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Feasibility assessed by the Memory Support Rating Scale (MSRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cognitive Processing Therapy + Memory Support (CPT + 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.
Intervention: MS (Behavioral)
Cognitive Processing Therapy (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.
Intervention: CPT (Behavioral)
Cognitive Processing Therapy + Memory Support (CPT + 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.
Intervention: CPT (Behavioral)
Outcomes
Primary Outcomes
Feasibility assessed by the Memory Support Rating Scale (MSRS)
Time Frame: 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.
Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
Time Frame: 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)
Time Frame: 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 Outcomes
- Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task(6 weeks)
- Post-treatment Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)(Baseline, 12 weeks)
- Post-treatment Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)(Baseline, 12 weeks)
- Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task(12 weeks)
- Post-treatment Skills of Cognitive Therapy (SoCT) - Patient(12 weeks)
- Follow-up Skills of Cognitive Therapy (SoCT) - Patient(6 months)
- Follow-up Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)(Baseline, 6 months)
- Follow-up Change in Memory of Therapy Content assessed by the Generalization Task(Baseline, 6 months)
- Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist(6 weeks)
- Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)(Baseline, 12 weeks)
- Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)(Baseline, 6 months)
- Follow-up Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)(Baseline, 6 months)
- Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task(Baseline, 6 weeks)
- Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient(6 weeks)
- Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist(12 weeks)
- Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)(Baseline, 6 months)
- Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task(6 months)
- Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task(Baseline, 12 weeks)
- Post-treatment Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)(Baseline, 12 weeks)