Positive Psychiatry for PTSD

(RFPP Trial)

Overseen By Naser Ahmadi, MD PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Intellectual disabilities, Psychotic behavior, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

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.

Is Reminder-Focused Positive Psychiatry safe for humans?

The available research does not provide specific safety data for Reminder-Focused Positive Psychiatry, but it has been studied in adolescents with conditions like ADHD and PTSD without reported safety concerns. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Positive Psychiatry for PTSD?

The research highlights the effectiveness of evidence-based treatments for PTSD, such as Cognitive Processing Therapy, which shows significant symptom improvement. This suggests that structured, evidence-based approaches, like Positive Psychiatry, could also be effective in treating PTSD. ^{11 12 13 14 15}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• attentional control condition (group process)
• Reminder Focused Positive Psychiatry

Trial Overview The 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.

How Is the Trial Designed?

Group I: RFPP group intervention Active Control 1 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 Group 1 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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

UCLA Cousins Center for Psychoneuroimmunology

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 2,643 veterans receiving treatment for PTSD, 25.9% experienced substantial improvement in symptoms, while 74.1% showed modest improvement, indicating that significant progress is possible in routine clinical practice.

The only strong predictor of substantial improvement was gender, with men having lower odds of achieving significant symptom reduction compared to women, suggesting that treatment approaches may need to be tailored based on gender differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. Shiner, B., Gui, J., Leonard Westgate, C., et al.[2023]

The Prolonged Exposure for Primary Care (PE-PC) treatment, developed for veterans with PTSD, has shown efficacy in reducing PTSD symptoms and could serve as a new access point for effective care in primary care settings.

The IMPACT study aims to assess the functional improvements in veterans receiving PE-PC compared to standard treatment, potentially increasing access to high-quality PTSD care for a larger number of veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving function through primary care treatment of PTSD: The IMPACT study protocol. Rauch, SAM., Kim, HM., Acierno, R., et al.[2023]

In a study of 110 patients with chronic PTSD, 79% expressed treatment preferences, with a significant majority preferring interpersonal psychotherapy over other options, despite prolonged exposure having more empirical support.

While treatment preferences did not significantly predict overall treatment outcomes, patients with comorbid depression who received their unwanted treatment showed worse PTSD symptoms, indicating that patient preference can subtly influence therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment preferences of psychotherapy patients with chronic PTSD. Markowitz, JC., Meehan, KB., Petkova, E., et al.[2016]

Measurement-based care (MBC) can help identify patients with posttraumatic stress disorder (PTSD) who are not responding to treatment as early as the sixth session, allowing for timely adjustments to their treatment plans.

In a study involving 2,182 patients from VA PTSD specialty clinics, session-by-session benchmarks were developed to visualize treatment progress using the PTSD Checklist (PCL-5), enhancing the potential for personalized, evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expected symptom change trajectories for the early identification of probable treatment nonresponse in VA PTSD specialty care clinics: A proof-of-concept. Darnell, BC., Benfer, N., Vannini, MBN., et al.[2023]

In a study involving 134 therapists and 188 patients, significant reductions in PTSD symptoms were observed across all training conditions, indicating that evidence-based psychotherapy can effectively improve patient outcomes in routine care settings.

Therapists who received Standard Consultation (without audio review) achieved greater improvements in patient PTSD symptoms compared to those with No Consultation, suggesting that consultation is beneficial for therapist training, while audio review may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled effectiveness trial of training strategies in cognitive processing therapy for posttraumatic stress disorder: Impact on patient outcomes. Monson, CM., Shields, N., Suvak, MK., et al.[2019]

In a study of 73 veterans with chronic combat-related PTSD, risperidone significantly improved overall PTSD symptoms and specifically reduced arousal symptoms compared to placebo over a 4-month period.

Risperidone was well tolerated and showed potential benefits for a range of psychiatric symptoms, suggesting that atypical antipsychotics like risperidone may be effective beyond just treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive risperidone in the treatment of chronic combat-related posttraumatic stress disorder. Bartzokis, G., Lu, PH., Turner, J., et al.[2015]

A review of 12 controlled studies indicates that atypical antipsychotics are effective and safe for treating posttraumatic stress disorder (PTSD), with some evidence of efficacy in managing related symptoms like anxiety and depression.

While the findings support the use of atypical antipsychotics for PTSD, the overall evidence is limited, suggesting a need for further research to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atypical antipsychotics in the treatment of posttraumatic stress disorder. Wang, HR., Woo, YS., Bahk, WM.[2013]

The FDA and the Spanish Ministry of Health have approved pilot studies for MDMA-assisted psychotherapy in chronic PTSD patients who have not responded to conventional treatments, indicating a favorable risk/benefit ratio for this approach.

These studies, funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), aim to rigorously evaluate the safety and efficacy of MDMA in treating PTSD over a five-year period, with an estimated cost of 5 million dollars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. Doblin, R.[2013]

The brief reminder-focused positive psychiatry and suicide prevention (RFPP-S) intervention significantly reduced PTSD symptoms and suicidal ideation among youths, with an 80% reduction in suicidal ideation compared to only 15% in the treatment as usual group.

RFPP-S led to faster stabilization of PTSD crises (average of 2 days) and a 0% readmission rate for suicidality one month post-discharge, compared to a 20% readmission rate in the control group, indicating its effectiveness in improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reminder-Focused Positive Psychiatry: Suicide Prevention Among Youths With Comorbid Posttraumatic Stress Disorder and Suicidality. Ahmadi, N., Pynoos, R., Leuchter, A., et al.[2022]

The reminder-focused positive psychiatry (RFPP) intervention significantly improved ADHD and PTSD symptoms, as well as vascular function and overall well-being in adolescents, with more robust results compared to trauma-focused cognitive-behavioral therapy (TF-CBT) after a 6-week trial involving 11 participants.

At the 12-month follow-up, RFPP continued to show lasting benefits, including reduced inflammation and increased resilience and gratitude, with no reports of psychiatric hospitalization or suicidal ideation in either group, highlighting its potential as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder. Ahmadi, N., Chaudhry, S., Salam, T., et al.[2022]

In a pilot study with 12 participants, the Processing of Positive Memories Technique (PPMT) showed promising effects on reducing PTSD severity, with 9 out of 12 participants demonstrating reliable improvements.

PPMT also positively impacted depression and negative affect levels, suggesting it may be a valuable addition to existing PTSD treatments, particularly in enhancing emotional regulation and cognitive processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Label Pilot Study on Posttrauma Health Impacts of the Processing of Positive Memories Technique (PPMT). Contractor, AA., Jin, L., Weiss, NH.[2023]

Out of 13 reviewed PTSD intervention manuals, only about 54% explicitly addressed positive memories, while around 69% discussed positive emotions and cognitions, indicating a limited focus on positive internal experiences in most therapies.

Eye Movement Desensitization and Reprocessing (EMDR) was found to have the most comprehensive approach to incorporating positive internal experiences, suggesting it may be particularly effective in addressing the emotional deficits associated with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Internal Experiences in PTSD Interventions: A Critical Review. Contractor, AA., Weiss, NH., Forkus, SR., et al.[2023]

In a study of 203 trauma-exposed individuals, it was found that higher severity of PTSD symptoms negatively impacted the number of specific positive memories recalled, suggesting that trauma can hinder positive memory encoding and retrieval.

The accessibility of positive memories was also negatively affected by PTSD symptoms, indicating that integrating positive memory recall into trauma treatment could be beneficial for improving mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of positive memory recall count and accessibility with post-trauma mental health. Contractor, AA., Banducci, AN., Dolan, M., et al.[2023]

A study involving 183 participants (60 from a community mental health center and 123 from Amazon's Mechanical Turk) found that individuals with PTSD are open to discussing positive memories in therapy, which could enhance their treatment experience.

Participants reported that focusing on positive memories could improve mood, self-esteem, and overall satisfaction with PTSD treatment, suggesting that integrating this approach could be beneficial in existing therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Examination of Client Perspectives on a Positive Memory Technique for PTSD. Caldas, SV., Jin, L., Dolan, M., et al.[2021]

The Positive Memory-PTSD model suggests that focusing on positive memory retrieval can be beneficial for individuals with PTSD, emphasizing the need to differentiate between specific and overgeneral positive memories.

The review highlights the importance of considering individual differences, such as trauma type and co-occurring conditions, which may influence how positive memories affect PTSD symptoms and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical considerations for the positive memory-posttraumatic stress disorder model. Contractor, AA., Banducci, AN., Weiss, NH.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Improving function through primary care treatment of PTSD: The IMPACT study protocol. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment preferences of psychotherapy patients with chronic PTSD. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Expected symptom change trajectories for the early identification of probable treatment nonresponse in VA PTSD specialty care clinics: A proof-of-concept. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled effectiveness trial of training strategies in cognitive processing therapy for posttraumatic stress disorder: Impact on patient outcomes. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adjunctive risperidone in the treatment of chronic combat-related posttraumatic stress disorder. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Atypical antipsychotics in the treatment of posttraumatic stress disorder. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Reminder-Focused Positive Psychiatry: Suicide Prevention Among Youths With Comorbid Posttraumatic Stress Disorder and Suicidality. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Open Label Pilot Study on Posttrauma Health Impacts of the Processing of Positive Memories Technique (PPMT). [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Positive Internal Experiences in PTSD Interventions: A Critical Review. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Relation of positive memory recall count and accessibility with post-trauma mental health. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

An Exploratory Examination of Client Perspectives on a Positive Memory Technique for PTSD. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Critical considerations for the positive memory-posttraumatic stress disorder model. [2022]