Positive Psychiatry for PTSD
(RFPP Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Intellectual disabilities, Psychotic behavior, Seizure disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD. Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Positive Psychiatry for PTSD?
Is Reminder-Focused Positive Psychiatry safe for humans?
How is the Reminder Focused Positive Psychiatry treatment different from other PTSD treatments?
Reminder Focused Positive Psychiatry is unique because it emphasizes processing positive memories, which is less common in traditional PTSD treatments that focus on traumatic memories. This approach aims to improve mood, positive thoughts, and self-esteem by integrating positive memory recall into therapy.1112131415
Eligibility Criteria
This trial is for boys and girls aged 11-15 with documented PTSD. They must be able to read and write in English. It's not for those with substance use disorders, other neurodevelopmental disorders, psychotic or self-injurious behavior, seizure or language disorders, intellectual disabilities, or eye disorders.Inclusion Criteria
You are a boy or girl who has been diagnosed with PTSD.
You are between the ages of 11 and 15.
Able to read/write in English
See 2 more
Exclusion Criteria
You have been diagnosed with drug or alcohol addiction.
You have other conditions that affect your brain development.
You have shown behavior where you harm yourself or have experienced hallucinations or delusions.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive twice weekly telehealth intervention of either RFPP or group process for 6 weeks
6 weeks
12 visits (virtual)
Follow-up
Participants undergo neuropsychiatric assessments and monitoring of vascular function and biomarkers
24 weeks
4 visits (in-person) at baseline, 3, 6, and 24 weeks
Treatment Details
Interventions
- attentional control condition (group process) (Behavioral Intervention)
- Reminder Focused Positive Psychiatry (Behavioral Intervention)
Trial OverviewThe study tests Reminder Focused Positive Psychiatry (RFPP) against an attention control group process in adolescents with PTSD. Participants will receive telehealth sessions twice a week for six weeks and undergo assessments at multiple points to measure the intervention's impact on PTSD symptoms and biomarkers.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: RFPP group interventionActive Control1 Intervention
The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices.
Group II: attentional control condition (group process)Placebo Group1 Intervention
Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy. Parents will receive 4 sessions of relaxation techniques.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLALos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
UCLA Cousins Center for PsychoneuroimmunologyCollaborator
References
Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. [2023]Identifying predictors of improvement amongst patients receiving routine treatment for post-traumatic stress disorder (PTSD) could provide information about factors that influence the clinical effectiveness of guideline-concordant care. This study builds on prior work by accounting for delivery of specific evidence-based treatments (EBTs) for PTSD while identifying potential predictors of clinical improvement using patient-reported outcomes measurement.
Improving function through primary care treatment of PTSD: The IMPACT study protocol. [2023]Despite the availability of effective psychological interventions for PTSD, access to and retention in these interventions remains problematic. Of note, the Veterans Health Administration (VHA) developed and implemented post-deployment health surveys that screen for PTSD in primary care (PC), but effective PC-based, psychological intervention treatment options have yet to be established. To address the literal physical gap between where the patients first present for care (i.e., primary care) and where they must go to receive first-line treatment for PTSD (i.e., specialty mental health), study investigators developed a 4-6 visit Prolonged Exposure for Primary Care (PE-PC) treatment that has shown efficacy in reduction of PTSD. To extend previous work to recovery-based mental health care, the Improving Function Through Primary Care Treatment of PTSD (IMPACT) study examined function as assessed by the World Health Organization Disability Assessment Schedule [WHODAS 2.0; (Axelsson, Lindsäter, Ljótsson, Andersson, & Hedman-Lagerlöf, 2017)]. Veterans presenting in VHA primary care mental health integration (PCMHI) clinics with PTSD or significant subsyndromal PTSD who met minimal inclusion and exclusion criteria were randomly assigned to PE-PC or treatment as usual (TAU). If proven effective in improving function, PE-PC would provide a new access point for high quality PTSD care and allow greater numbers of veterans to access effective PTSD treatment. Trial Registration: http://ClinicalTrials.gov: NCT03581981.
Treatment preferences of psychotherapy patients with chronic PTSD. [2016]Patient treatment preference may moderate treatment effect in major depressive disorder (MDD) studies. Little research has addressed preference in posttraumatic stress disorder (PTSD); almost none has assessed actual patients' PTSD psychotherapy preferences. From a 14-week trial of chronic PTSD comparing prolonged exposure, relaxation therapy, and interpersonal psychotherapy, we report treatment preferences of the 110 randomized patients, explore preference correlates, and assess effects on treatment outcome.
Expected symptom change trajectories for the early identification of probable treatment nonresponse in VA PTSD specialty care clinics: A proof-of-concept. [2023]The purpose of measurement-based care (MBC) is to detect treatment nonresponse sufficiently early in treatment to adjust treatment plans and prevent failure or dropout. Thus, the potential of MBC is to provide the infrastructure for a flexible, patient-centered approach to evidence-based care. However, MBC is underutilized across the Department of Veterans Affairs (VA) posttraumatic stress disorder (PTSD) specialty clinics, likely because no actionable, empirically determined guidelines for using repeated measurement effectively are currently available to clinicians. With data collected as part of routine care in VA PTSD specialty clinics across the United States in the year prior to COVID-19 (n = 2,182), we conducted a proof-of-concept for a method of generating session-by-session benchmarks of probable patient nonresponse to treatment, which can be visualized alongside individual patient data using the most common measure of PTSD symptoms used in VA specialty clinics, the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5). Using survival analysis, we first identified the probability of cases reaching clinically significant change at each session, as well as any significant moderators of treatment response. We then generated a multilevel model with initial symptom burden predicting the trajectory of PCL-5 scores across sessions. Finally, we determined the slowest changing 50% and 60% of all cases to generate benchmarks at each session for each level of the predictor(s) and then assessed the accuracy of these benchmarks at each session for classifying treatment responders and nonresponders. The final models were able to accurately identify nonresponders as early as the sixth session of treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
A randomized controlled effectiveness trial of training strategies in cognitive processing therapy for posttraumatic stress disorder: Impact on patient outcomes. [2019]This randomized controlled hybrid implementation/effectiveness trial aimed to compare the impact of three different models of training and consultation by examining the PTSD treatment outcomes achieved by therapists who were learning a front-line recommended psychotherapy for posttraumatic stress disorder (PTSD), Cognitive Processing Therapy (CPT; Resick, Monson, & Chard, 2017). Therapists (N = 134) were randomized into one of three conditions after attending a standard CPT training workshop: No Consultation with delayed feedback on CPT fidelity, Standard Consultation involving discussion and conceptualization of cases without session audio review, and Consultation Including Audio Review, which included a review of segments of audiorecorded CPT sessions. Across all training conditions, the patients treated by these therapists (N = 188) evidenced statistically significant reductions in PTSD symptoms, (d = -0.95 to -1.78), comorbid symptoms and functioning (d = -0.27 to -0.51). However, patients of therapists in the Standard Consultation condition (ΔPTSD = - 19.64, d = -1.78) experienced significantly greater improvement than those in the No Consultation condition (ΔPTSD = - 10.54, d = -0.95, ΔDEV = 6.30, ΔParms = 2, p = .043). This study demonstrates that patients who receive evidence-based psychotherapy for PTSD in routine care settings can experience significant symptom improvement. Our findings also suggest that to maximize patient benefit, therapist training should include consultation, but that audio review of sessions during consultation may not be necessary, at least for structured protocols. Implications for implementation, including the reduction of burden and cost of post-workshop support, are discussed.
Adjunctive risperidone in the treatment of chronic combat-related posttraumatic stress disorder. [2015]The efficacy and safety of risperidone was evaluated in veteran patients with chronic combat-related posttraumatic stress disorder (PTSD) who were referred to a residential treatment program.
Atypical antipsychotics in the treatment of posttraumatic stress disorder. [2013]This study reviewed extant published articles on the efficacy and safety of atypical antipsychotics for the treatment of posttraumatic stress disorder (PTSD).
A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. [2013]The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.
Reminder-Focused Positive Psychiatry: Suicide Prevention Among Youths With Comorbid Posttraumatic Stress Disorder and Suicidality. [2022]This study aimed to investigate the effect of brief reminder-focused positive psychiatry and suicide prevention (RFPP-S) on suicidal ideation, posttraumatic stress disorder (PTSD) symptoms, and clinical outcomes among youths with PTSD treated in psychiatric emergency rooms.
A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder. [2022]To investigate the impact of reminder-focused positive psychiatry (RFPP) on attention-deficit/hyperactive disorder (ADHD) and posttraumatic stress disorder (PTSD) symptoms, vascular-function, inflammation and well-being of adolescents with comorbid ADHD and PTSD.
Open Label Pilot Study on Posttrauma Health Impacts of the Processing of Positive Memories Technique (PPMT). [2023]Processing of Positive Memories Technique (PPMT) was proposed as a novel intervention for posttraumatic stress disorder (PTSD). PPMT comprises of 5 sessions focused on identifying and processing positive memories. As an open label pilot study, we explored PPMT's effects on PTSD severity, depression severity, affect and cognitive processes, and therapeutic alliance. A sample of 12 trauma-exposed participants seeking services at a University Psychology Clinic participated in 5 PPMT sessions (Mage=29.25 years; 58.30% women). We used the reliable change indices and clinically significant change score approach. The following number of participants showed statistically reliable changes: 9 participants for PTSD severity (8 recovered/improved); 6 participants for depression severity (5 improved); 5 participants for positive affect levels (2 recovered/improved); 9 participants for negative affect levels (8 recovered); 9 participants for posttrauma cognitions (7 recovered/improved); 5 participants for positive emotion dysregulation (4 recovered); 11 participants for number of retrieved positive memories (3 recovered); and 5 participants for therapeutic alliance (4 recovered). PPMT may impact certain posttrauma targets more effectively (PTSD, depression, negative affect, posttrauma cognitions). PPMT may be more helpful in improving regulation rather than levels of positive affect. PPMT, if supported in further investigations, may add to the clinician tool-box of PTSD interventions.
Positive Internal Experiences in PTSD Interventions: A Critical Review. [2023]Evidence suggests that individuals with post-traumatic stress disorder (PTSD) symptoms exhibit deficits in positive internal experiences. This study critically reviewed empirically validated PTSD interventions to determine (1) whether positive memories, cognitions, and emotions were explicitly addressed and (2) the goals of focusing on these positive internal experiences. We selected 11 empirically validated PTSD interventions listed as "recommended/strongly recommended" in recently published reviews, reviewed existing literature for studies using these interventions (N = 1,070), short-listed randomized controlled trial studies meeting predetermined inclusion criteria for the selected interventions (in English, developed for adults, individual therapy modality, in-person administration, tailored to PTSD; N = 47), and emailed authors (N = 41) to obtain the unique intervention manuals. Hereby, we reviewed 13 unique empirically validated PTSD intervention manuals. Findings indicated 53.85%, 69.23%, and 69.23% of reviewed manuals explicitly discussed positive memories, emotions, and cognitions, respectively. Primarily, positive memories were integral to mechanisms underlying PTSD, a precursor to targeting negative experiences, an indicator of treatment progress, or a way to identify client problems; positive emotions were discussed when providing psychoeducation on PTSD/trauma reactions; and positive cognitions were addressed in reference to coping with negative experiences or as targets to enhance self-concept. This review demonstrates that comparatively, positive memories are infrequently elicited in the reviewed interventions; positive emotions and cognitions are explicitly referenced in two-thirds of the reviewed interventions but are included as a primary focus for therapeutic processing only in a few interventions; and eye movement desensitization and reprocessing has the most comprehensive focus on positive internal experiences.
Relation of positive memory recall count and accessibility with post-trauma mental health. [2023]Positive memory encoding and retrieval deficits have an empirical relation with several post-trauma outcomes. Drawing from the Contractor et al. model, we examined relations between positive memory characteristics and post-trauma mental health indicators. A trauma-exposed community sample of 203 participants (Mage = 35.40 years; 61.10% female) was recruited via Amazon's Mechanical Turk. Participants completed measures of posttraumatic stress disorder (PTSD; PTSD Checklist for DSM-5), depression (Patient Health Questionnaire-9), posttraumatic cognitions (Posttraumatic Cognitions Inventory), affect (Positive and Negative Affect Schedule), count/number of recalled specific positive memories (Autobiographical Memory Test) and accessibility of a specific positive memory (i.e., subjective ease of recalling details of a memory; Memory Experiences Questionnaire-Short Form). Linear regression results indicated that PTSD intrusion severity, PTSD negative alterations in cognitions and mood (NACM) severity, PTSD alterations in arousal and reactivity (AAR) severity, self-blame, and positive affect significantly and negatively predicted the count of specific positive memories. Further, PTSD NACM severity, PTSD AAR severity, negative cognitions about the self, and negative affect significantly and negatively predicted accessibility of a specific positive memory. Thus, count/accessibility of specific positive memories was associated with several post-trauma mental health indicators; this highlights the relevance and potential impact of integrating positive memories into trauma treatment.
An Exploratory Examination of Client Perspectives on a Positive Memory Technique for PTSD. [2021]Posttraumatic stress disorder (PTSD) treatments primarily address traumatic memories, despite PTSD's association with both traumatic and positive memory difficulties. Addressing this gap, we explored the perspectives of trauma-exposed individuals with mental health treatment experience on therapeutically addressing positive memories. A treatment-seeking sample from a community mental health center (n1 = 60) and a community sample from Amazon's Mechanical Turk (n2 = 123) were queried on the acceptability, feasibility, and delivery/components of a pilot positive memory technique. Results indicated interest or willingness in therapeutically discussing positive memories; most endorsed benefits were improved mood, positive thoughts, and self-esteem. Few barriers were identified (e.g., lack of evidence) compared with feasibility factors (ease/usefulness, improved satisfaction/tolerability, and engagement in PTSD treatment). Preferred treatment components included identifying/discussing positive memories, eliciting associated positive affect, and writing about the positive memory as homework. Results provide formative support for the development and integration of a positive memory technique into PTSD treatments.
Critical considerations for the positive memory-posttraumatic stress disorder model. [2022]Posttraumatic stress disorder (PTSD) includes changes in processes such as encoding and retrieval for both traumatic and positive memories. However, most work has predominantly focused on traumatic memories. Thus, Contractor and colleagues proposed a Positive Memory-PTSD model, which highlighted potential benefits associated with and mechanisms underlying positive memory retrieval/processing among individuals reporting PTSD symptoms. To enhance research on and clinical impacts of this model, the current review provides critical considerations for the Positive Memory-PTSD model. Drawing from emerging research and clinical observations, we (i) clarify that the model addresses specific versus overgeneral positive memories; (ii) underscore the importance of considering the heterogeneity in, and transitionary nature of, affect processes following positive memory retrieval; and (iii) highlight the rationale for considering trauma type/count and co-occurring conditions, as potential moderators of relations between positive memory processing and PTSD. Hereby, we provide an updated Positive Memory-PTSD model and implications for positive memory interventions drawing from this model.