Trial Outcomes & Findings for Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers (NCT NCT02386605)
NCT ID: NCT02386605
Last Updated: 2021-04-08
Results Overview
This scale is a 43-item report of a patient's behavior and functioning across the following domains: physical functioning (e.g., vision, hearing), personal care skills (e.g., eating, grooming), interpersonal skills (e.g., initiating, accepting, and maintaining social contacts; effectively communicating), social acceptability (e.g., absence of verbal and physical abuse, absence of repetitive behaviors), community activities (e.g., shopping, using the telephone, paying bills, use of leisure time, use of public transportation), and work skills (e.g., employable skills, level of supervision, punctuality). Each item is rated on a 5 point likert scale. A functional skill composite is created by summing the interpersonal relationships, activities, and work skills domains. The range for the summary score was 64 - 120, with higher scores indicating better functioning.
COMPLETED
NA
99 participants
3 months
2021-04-08
Participant Flow
Of 99 enrolled participants 79 met inclusion criteria and were randomized to one of the two conditions
Participant milestones
| Measure |
Treatment
Motivational Interviewing Treatment group
Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
|
Control
Relaxation Skills Training group
Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
38
|
|
Overall Study
COMPLETED
|
34
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers
Baseline characteristics by cohort
| Measure |
Treatment
n=41 Participants
Motivational Interviewing Treatment group
Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
|
Control
n=38 Participants
Relaxation Skills Training group
Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 8.8 • n=39 Participants
|
54.1 years
STANDARD_DEVIATION 8.2 • n=41 Participants
|
54.5 years
STANDARD_DEVIATION 8.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
75 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThis scale is a 43-item report of a patient's behavior and functioning across the following domains: physical functioning (e.g., vision, hearing), personal care skills (e.g., eating, grooming), interpersonal skills (e.g., initiating, accepting, and maintaining social contacts; effectively communicating), social acceptability (e.g., absence of verbal and physical abuse, absence of repetitive behaviors), community activities (e.g., shopping, using the telephone, paying bills, use of leisure time, use of public transportation), and work skills (e.g., employable skills, level of supervision, punctuality). Each item is rated on a 5 point likert scale. A functional skill composite is created by summing the interpersonal relationships, activities, and work skills domains. The range for the summary score was 64 - 120, with higher scores indicating better functioning.
Outcome measures
| Measure |
Treatment
n=41 Participants
Motivational Interviewing Treatment group
Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
|
Control
n=38 Participants
Relaxation Skills Training group
Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
|
|---|---|---|
|
Strauss-Carpenter Level of Function Scale
|
97.69 score on a scale
Standard Deviation 13.8
|
94.56 score on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: 2 weeksThe CAINS is a 13-item instrument that yields two subscales which measure the two primary negative symptom factors: Motivation and Pleasure (MAP) which measures experiential negative symptoms and Expression which measures the expressive negative symptoms. The MAP was used as a primary dependent variable, it includes 9 items rated 0-4 and yields a mean subscale (0-4). Higher scores reflect greater impairment.
Outcome measures
| Measure |
Treatment
n=41 Participants
Motivational Interviewing Treatment group
Motivational Interviewing and Cognitive Behavioral Therapy: group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
|
Control
n=38 Participants
Relaxation Skills Training group
Relaxation Skills: Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
|
|---|---|---|
|
Clinical Assessment Interview for Negative Symptoms
|
2.1 score on a scale
Standard Deviation .82
|
1.3 score on a scale
Standard Deviation .78
|
Adverse Events
Treatment
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Felice Reddy
Greater Los Angeles VA Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place