Trial Outcomes & Findings for Assessing Mental Illness Recovery (NCT NCT01043653)

NCT ID: NCT01043653

Last Updated: 2017-03-08

Results Overview

The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.

• Recruitment status: COMPLETED
• Target enrollment: 250 participants
• Primary outcome timeframe: ~1-year
• Results posted on: 2017-03-08

Participant Flow

Participant milestones

Measure	Maryland Assessment of Recovery in Serious Mental Illness Individuals with serious mental illness treated in mental health outpatient programs
Overall Study STARTED	250
Overall Study COMPLETED	186
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing Mental Illness Recovery

Baseline characteristics by cohort

Measure	Maryland Assessment of Recovery in Serious Mental Illness n=250 Participants Individuals with serious mental illness treated in VA mental health outpatient programs
Age, Continuous	51.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants

PRIMARY outcome

Timeframe: ~1-year

Population: The PANSS had additional missing data from 3 participants

The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.

Outcome measures

Measure	Maryland Assessment of Recovery in Serious Mental Illness n=183 Participants Individuals with serious mental illness treated in VA mental health outpatient programs
Positive and Negative Symptom Scale (PANSS) Baseline	1.9 units on a scale Standard Deviation 0.4
Positive and Negative Symptom Scale (PANSS) Follow-up	1.8 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: ~ 1-year

The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.

Outcome measures

Measure	Maryland Assessment of Recovery in Serious Mental Illness n=186 Participants Individuals with serious mental illness treated in VA mental health outpatient programs
Maryland Assessment of Recovery in Serious Mental Illness Baseline	95.9 units on a scale Standard Deviation 19.5
Maryland Assessment of Recovery in Serious Mental Illness Follow-up	95.7 units on a scale Standard Deviation 19.2

Adverse Events

Maryland Assessment of Recovery in Serious Mental Illness

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maryland Assessment of Recovery in Serious Mental Illness n=250 participants at risk Individuals with serious mental illness treated in mental health outpatient programs
Psychiatric disorders Psychiatric Hospitalization	2.4% 6/250 • Number of events 6 • ~ 1 year
General disorders Medical Hospitalization	1.2% 3/250 • Number of events 3 • ~ 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Drapalski

VISN 5 MIRECC

Phone: 410-637-1855

Email: amy.drapalski@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place