Trial results for a study investigating personalized care methods for Post Traumatic Stress Disorder (PTSD), Anxiety Disorders, and Obsessive-Compulsive Disorder were posted on ClinicalTrials.gov on 2025-07-30, with 61 participants enrolled.
Background
Post Traumatic Stress Disorder (PTSD), Anxiety Disorders, and Obsessive-Compulsive Disorder (OCD) are complex mental health conditions that often require tailored treatment approaches. Traditional therapeutic methods can be effective, but optimizing treatment delivery, such as personalizing module sequencing and timing of discontinuation, holds potential to enhance efficiency and patient outcomes. This study explored such personalized care methods, aiming to understand their feasibility, tolerability, and acceptability in a diverse patient population.
Trial design
This completed study, designated as Phase NA, enrolled 61 participants to investigate conditions including Anxiety Disorders, Post Traumatic Stress Disorder, and Obsessive-Compulsive Disorder. The trial, titled 'Increasing Treatment Efficacy Using SMART Methods for Personalizing Care', utilized a sequential multiple assignment randomized trial (SMART) design. It aimed to determine the feasibility, tolerability, and acceptability of personalized treatment delivery, specifically focusing on module sequencing and treatment discontinuation timing. Participants were assigned to one of three sequencing configurations: a Standard Group, a Capitalization Group, or a Compensation Group, each receiving either a brief or full intervention.
Key results
The trial reported key measurements related to changes in clinical severity and self-reported anxiety symptoms across different intervention groups:
- Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) (score on a scale):
- Standard Group, Brief Intervention: Mean change of -2.40 (Standard Deviation 1.26).
- Standard Group, Full Intervention: Mean change of -2.86 (Standard Deviation 1.46).
- Capitalization Group, Brief Intervention: Mean change of -2.71 (Standard Deviation 1.25).
- Capitalization Group, Full Intervention: Mean change of -2.00 (Standard Deviation 1.14).
- Compensation Group, Brief Intervention: Mean change of -3.00 (Standard Deviation 1.15).
- Compensation Group, Full Intervention: Mean change of -3.33 (Standard Deviation 0.58).
- Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) (score on a scale):
- Standard Group, Brief Intervention: Mean change of -2.56 (Standard Error 2.40).
- Standard Group, Full Intervention: Mean change of -1.57 (Standard Error 4.69).
- Capitalization Group, Brief Intervention: Mean change of -2.00 (Standard Error 2.74).
- Capitalization Group, Full Intervention: Mean change of -2.00 (Standard Error 0).
- Compensation Group, Brief Intervention: Mean change of -3.33 (Standard Error 2.66).
- Compensation Group, Full Intervention: Mean change of -7.50 (Standard Error 0.71).
What this means
The posted results provide data on changes in clinical severity and self-reported anxiety symptoms for participants in a study exploring personalized care methods for anxiety disorders, PTSD, and OCD. Across all intervention groups and durations, negative mean changes were observed for both clinical severity and anxiety symptoms, suggesting a reduction in these measures. The largest mean reduction in clinical severity was -3.33 in the Compensation Group, Full Intervention, while the largest mean reduction in self-reported anxiety symptoms was -7.50 in the Compensation Group, Full Intervention. As this was a feasibility and tolerability study, these observed changes contribute to understanding the potential impact of personalized treatment delivery strategies, laying groundwork for further research into optimizing care for these conditions.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04642898, titled 'Increasing Treatment Efficacy Using SMART Methods for Personalizing Care', were posted on 2025-07-30 on clinicaltrials.gov.