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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

3 months

Results posted on

2021-04-08

Participant Flow

Of 99 enrolled participants 79 met inclusion criteria and were randomized to one of the two conditions

Participant milestones

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

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 months

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.

Outcome measures

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 weeks

The 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 3104783711

Results disclosure agreements

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