Cognitive Processing Therapy (CPT) Memory Support (MS) Study
ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CPT
BehavioralCPT 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
BehavioralThe MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cognitive Processing Therapy + Memory Support (CPT + MS)Experimental treatment 2 interventions
Group B: Cognitive Processing Therapy (CPT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 weeks2
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.
Time frame
12 weeks3
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.
Time frame
6 months4
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.
Time frame
12 weeksSecondary outcomes
1
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.
Time frame
6 weeks2
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.
Time frame
12 weeks3
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.
Time frame
6 months4
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.
Time frame
Baseline, 6 weeksOther outcomes
1
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.
Time frame
Baseline, 12 weeks2
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.
Time frame
Baseline, 6 months3
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.
Time frame
Baseline, 12 weeks4
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.
Time frame
Baseline, 6 monthsSponsors and contacts
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Boston University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
VA Boston Healthcare System
Collaborator
Source ClinicalTrials.gov