Trial Outcomes & Findings for Facilitating Engagement in Evidence-Based Treatment for Early Psychosis (NCT NCT04532034)
NCT ID: NCT04532034
Last Updated: 2024-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline, through intervention completion (up to 3 months)
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
Peer-Delivered Decision Support Intervention
Peer-Delivered Decision Support Intervention: An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
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|---|---|
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Overall Study
STARTED
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12
|
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Overall Study
COMPLETED
|
6
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Overall Study
NOT COMPLETED
|
6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was missing from 2 participants on the Decisional Conflict Scale at baseline.
Baseline characteristics by cohort
| Measure |
Peer-Delivered Decision Support Intervention
n=12 Participants
Peer-Delivered Decision Support Intervention: An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
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|---|---|
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Age, Continuous
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22.42 years
STANDARD_DEVIATION 2.47 • n=12 Participants
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Sex: Female, Male
Female
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3 Participants
n=12 Participants
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Sex: Female, Male
Male
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9 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Asian
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2 Participants
n=12 Participants
|
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Race/Ethnicity, Customized
African American
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6 Participants
n=12 Participants
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Race/Ethnicity, Customized
White
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4 Participants
n=12 Participants
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Race/Ethnicity, Customized
Hispanic/Latino
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1 Participants
n=12 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=12 Participants
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Region of Enrollment
United States
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12 Participants
n=12 Participants
|
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Decisional Conflict Scale
|
26.39 units on a scale
STANDARD_DEVIATION 7.55 • n=10 Participants • Data was missing from 2 participants on the Decisional Conflict Scale at baseline.
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer-Delivered Decision Support Intervention
n=5 Participants
Peer-Delivered Decision Support Intervention: An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
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|---|---|
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Change in Decisional Conflict Scale
|
0.55 score on a scale
Standard Deviation 18.68
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Adverse Events
Peer-Delivered Decision Support Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peer-Delivered Decision Support Intervention
n=12 participants at risk
Peer-Delivered Decision Support Intervention: An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
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|---|---|
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Infections and infestations
Urinary Tract Infection
|
8.3%
1/12 • 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).
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Psychiatric disorders
Suicidal ideation
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8.3%
1/12 • 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).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place