Psychoeducational Intervention for PTSD

Overseen By William A Edmonds, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Asthma, Emphysema, COPD, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop new methods to help veterans with PTSD (Post-Traumatic Stress Disorder) manage stress more effectively. Participants will engage in a psychological skills training program, which includes techniques such as stress management, cognitive processing, and mindfulness, tailored to individual needs. The trial incorporates a racecar simulation to practice these skills in a controlled setting, with the hope that the benefits will transfer to real life. Veterans diagnosed with PTSD who have completed the Veterans Trust Self-Regulatory Mastery course using a race simulator may be well-suited for this study. As an unphased trial, this study offers veterans a unique opportunity to explore innovative stress management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychoeducational intervention is safe for veterans with PTSD?

Research shows that psychological treatments, like the one in this trial, have positive effects. Studies have found that these treatments can greatly reduce PTSD symptoms, with many participants feeling better after similar programs.

The treatment in this trial, called Psychological Skills Training, uses various methods to help manage stress and emotions. Techniques may include controlling physical stress responses, using positive self-talk, and imagining calming scenes.

Previous research suggests that these programs can reduce the risk of depression and anxiety. Participants usually tolerate them well, with few reports of serious side effects.

Overall, existing evidence supports the safety of these approaches, making them a promising option for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Psychological Skills Training for PTSD because it offers a personalized approach to managing stress, which is different from the typical therapy and medication options available. This treatment uniquely focuses on identifying each participant's Individual Zones of Optimal Functioning (IZOFs) using physiological measures like heart rate variability and muscle activity. By incorporating mindfulness and biofeedback techniques, it helps individuals learn self-regulation strategies tailored specifically to their needs. This personalized method holds promise for enhancing the effectiveness of PTSD treatment by directly targeting stress management skills.

What evidence suggests that this psychological skills training is effective for PTSD?

Research has shown that training in psychological skills can greatly alleviate PTSD symptoms. In this trial, participants will receive Psychological Skills Training (PST), which includes stress management and mindfulness elements. Studies have found that trauma-focused treatments and other psychological therapies can significantly improve PTSD, depression, and anxiety. Skills training, in particular, helps individuals better control their emotions and reduce relationship issues, common in PTSD. These treatments offer lasting benefits, with many patients experiencing improvement over time. The approach employs various techniques to help individuals manage stress and enhance self-control, making it a promising option for easing PTSD symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

William A Edmonds, PhD

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

This trial is for veterans diagnosed with PTSD. Participants should be interested in a psychoeducational program that uses racecar simulation to help manage symptoms. Specific eligibility details are not provided, but typically participants must meet certain health and psychological criteria.

Inclusion Criteria

All veterans of the US Military

I have been diagnosed with PTSD.

Completed the Veterans Trust Self-Regulatory Mastery course with the Race-Simulator

Exclusion Criteria

Extreme/incapacitating severity rating on the CAPS-5

I have asthma.

I have chronic obstructive pulmonary disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Adaptation

Participants visit the Race Lab to become acquainted with the lab and virtual environment, including a brief educational lesson on the Psychological Skills Training intervention.

1 week

1 visit (in-person)

Learning

Participants undergo the Learning phase of the experimental race-car psychoeducational intervention, completing five separate time-trials.

2 weeks

Multiple visits (in-person)

Modification

Participants engage in the Modification phase, completing five separate time-trials with increased performance criteria.

2 weeks

Multiple visits (in-person)

Application

Participants complete the Application phase, including five time-trials with competitors, to apply learned skills.

2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psychological Skills Training

Trial Overview

The study tests a Psychological Skills Training (PST) program designed to improve self-regulation in stressful situations, potentially helping with PTSD symptoms. It's personalized based on each veteran's unique responses within a simulated environment.

How Is the Trial Designed?

Group I: Trial Experimental Treatment 1 Intervention

Psychological Skills Training (PST). The PST will include elements, both generalized and idiosyncratic, for each participant and is considered an adapted model of stress inoculation skills training protocol. The specifics will include each participant's unique optimal and poor ranges of performance (i.e., IZOFs), which will be calculated utilizing HRV, BPM, EMG, respiration and subjective affect. The participants will be introduced to their IZOFs and then taught general and specific approaches to self-regulation using elements of a mindfulness protocol for BFB in a clinical environment. A dual-monitor setup for the BFB application will be employed.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

Structured Learning Therapy is a new skill training therapy aimed at improving the transfer of learned skills to real-life situations, which is crucial for effective treatment outcomes.

The paper discusses various methods and materials used in this therapy, highlighting the importance of tailored psycho-educational approaches to enhance the effectiveness of skill acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured learning therapy: development and evaluation. Goldstein, AP., Gershaw, NJ., Sprafkin, RP.[2019]

Social skills training is an effective treatment for social dysfunction in psychiatric outpatients, showing benefits for up to 16 months after the intervention, and is more effective than other methods like short-term psychotherapy.

This training focuses on teaching new social behaviors through practice, and it is recommended as the preferred treatment for patients with social dysfunction, particularly when they do not have other major psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of social dysfunction in nonpsychotic outpatients. A review. Stravynski, A., Shahar, A.[2019]

In a study involving 41 Libyan patients, psychoeducation and stress management workshops significantly reduced PTSD symptoms, with 15% of participants no longer meeting the diagnostic criteria for PTSD after the intervention.

Participants showed lower scores on the PTSD Checklist after the workshops, indicating that education about PTSD can effectively alleviate symptoms in individuals affected by mass trauma, although further research is needed to assess the long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Psychoeducation and Stress Coping Techniques on Posttraumatic Stress Disorder Symptoms. Mughairbi, FA., Abdulaziz Alnajjar, A., Hamid, A.[2021]

A systematic review of 66 trials involving 4190 patients with PTSD found that specific psychological interventions, such as cognitive behavioral therapy and exposure therapy, have large effect sizes, indicating they are effective in reducing PTSD symptoms.

No single psychological intervention was found to be consistently superior to others, but adherence to PTSD diagnostic criteria and trial quality were linked to larger effect sizes, suggesting that the effectiveness of these interventions can vary based on how well the trials are conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. Gerger, H., Munder, T., Gemperli, A., et al.[2014]

A study involving 342 health practitioners who attended workshops on the Skills for Psychological Recovery (SPR) found that most participants felt confident in using the intervention and considered it useful for disaster survivors experiencing mild to moderate distress.

The research suggests that health practitioners' attitudes towards evidence-based care influenced their perceptions of SPR's usefulness, highlighting the importance of focusing on well-supported modules to enhance acceptance and implementation in future training efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practitioner perceptions of Skills for Psychological Recovery: a training programme for health practitioners in the aftermath of the Victorian bushfires. Forbes, D., Fletcher, S., Wolfgang, B., et al.[2010]

In a study involving participants from a trauma healing intervention in Burundi, both PTSD psychoeducation and a control group showed reduced symptoms compared to a waitlist, indicating that interventions can be beneficial.

Interestingly, participants who did not receive PTSD psychoeducation experienced a greater reduction in symptoms than those who did, suggesting that psychoeducation may not always be helpful and could potentially hinder recovery in certain cultural contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a reconciliation workshop with and without PTSD psychoeducation in Burundian sample. Yeomans, PD., Forman, EM., Herbert, JD., et al.[2015]

The psychoeducational program developed for trauma patients aims to improve coping skills, self-understanding, and reflectiveness, utilizing attachment theory to guide its framework.

The program is tailored for various groups, including adult inpatients and adolescents in different treatment settings, addressing a wide range of trauma-related symptoms and disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A psychoeducational program for patients with trauma-related disorders. Allen, JG., Kelly, KA., Glodich, A.[2007]

Social skills training is an effective strategy for improving the social competence of patients with schizophrenia and other major mental disorders, helping to reduce relapses and enhance psychosocial functioning.

Training models, such as the 'basic' model with role playing and feedback, and the 'problem-solving' model that focuses on processing social messages, are essential components of a comprehensive rehabilitation program that includes ongoing support and appropriate medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training skills in the psychiatrically disabled: learning coping and competence. Liberman, RP., Mueser, KT., Wallace, CJ., et al.[2019]

The psychoeducation intervention, PTSD 102, significantly reduced PTSD symptoms in veterans, with a large effect size (d = .843) after eight weekly sessions, indicating its efficacy as a stand-alone treatment.

In addition to PTSD symptoms, the intervention also led to a significant decrease in depressive symptoms (effect size d = .749), highlighting the broader mental health benefits of including emotional support in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bring your spouse: Brief multifamily group outcome for posttraumatic stress disorder. Elder, WB., Rochester, NK., Rentz, TO., et al.[2023]

A systematic review of 126 randomized controlled trials found that certain factors, like having a comorbid diagnosis of depression and higher baseline PTSD severity, are linked to less effective treatment outcomes for PTSD.

Conversely, factors such as higher education, adherence to treatment homework, and experiencing a more recent trauma were associated with better treatment outcomes, highlighting the need for personalized approaches in PTSD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of factors associated with outcome of psychological treatments for post-traumatic stress disorder. Barawi, KS., Lewis, C., Simon, N., et al.[2022]

A study involving 51 earthquake survivors with PTSD found that a combined treatment of psychoeducation and medication (PEM) was more effective in reducing PTSD symptoms compared to medication alone.

The psychoeducation intervention, which included problem-solving strategies, significantly improved coping and symptom relief, highlighting the importance of integrating psychological support in PTSD treatment alongside medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of psychoeducation intervention on post-traumatic stress disorder and coping styles of earthquake survivors. Oflaz, F., Hatipoğlu, S., Aydin, H.[2022]

In a study of 149 patients with childhood-abuse-related PTSD, specific predictors such as depressive symptoms and social support were identified that could help personalize treatment, leading to better outcomes.

Using a personalized advantage index (PAI) to match patients with optimal treatments resulted in significant improvements in PTSD symptoms, suggesting that personalized therapy could enhance effectiveness compared to standard approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalization of Treatment for Patients with Childhood-Abuse-Related Posttraumatic Stress Disorder. Hoeboer, CM., Oprel, DAC., De Kleine, RA., et al.[2021]

The study outlines a design for a web-based cognitive remediation training aimed at enhancing neurocognitive functions that may help prevent the development of PTSD in trauma survivors.

By focusing on early intervention shortly after trauma exposure, the study aims to address the challenges of administering targeted training to improve emotional reactivity and regulation, potentially reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. Fine, NB., Achituv, M., Etkin, A., et al.[2020]

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