NCT04532034

Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

Completed NA Results posted Last updated 17 April 2024

What this trial tests

NA trial testing Peer-Delivered Decision Support Intervention in Psychotic Disorders in 12 participants. Completed in 31 March 2023.

Timeline

1 September 2020

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Temple University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	12
Start date	1 September 2020
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	3 locations across United States

Drugs / interventions tested

• Peer-Delivered Decision Support Intervention

Conditions studied

• Psychotic Disorders — all drugs for Psychotic Disorders →

Sponsor

Temple University

Who can join

Adults 18 to 30, any sex, with Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Decisional Conflict Scale Primary · Baseline, through intervention completion (up to 3 months)

Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Total scores on the Decisional Conflict Scale are calculated as: (sum of all items scores / the total number of items) x 25. For this study, 9 items were included. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.

Group	Value	95% CI
Peer-Delivered Decision Support Intervention	0.55	± 18.68

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were assessed at baseline and follow-up. For participants who completed a follow-up interview, assessment of adverse events pertained to the entire period of participants' participation in the study (approximately 3 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Peer-Delivered Decision Support Intervention

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Peer-Delivered Decision Su…
Urinary Tract Infection	Infections and infestations	—
Suicidal ideation	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT04532034 adverse events section.

Sponsor's own description

The purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (CSC). It is hypothesized that participants will experience a reduction in decision-making needs after participating in the intervention, and that study and intervention procedures will demonstrate feasibility and acceptability.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Facilitating treatment engagement for early psychosis through peer-delivered decision support: intervention development and protocol for pilot evaluation.
   Thomas EC, Suarez J, Lucksted A, Siminoff LA, et al · · 2021 · cited 2× · PMID 34689830 · DOI 10.1186/s40814-021-00927-8
2. Case Study Analysis of a Decision Coaching Intervention for Young Adults with Early Psychosis.
   Thomas EC, Lucksted A, Siminoff LA, Hurford I, et al · · 2025 · PMID 39746883 · DOI 10.1007/s10597-024-01425-w