Improving Negative Symptoms of Psychosis In Real-world Environments

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170051

Acronym

INSPIRE

Enrollment

Registered

2014-06-23

Start date

2014-07-01

Completion date

2018-09-03

Last updated

2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

negative symptoms, cognition, functioning, defeatist attitudes, psychosocial treatment

Brief summary

This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.

Interventions

BEHAVIORALCBSST-CCT

BEHAVIORALGoal focused supportive contact

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE. 1. Voluntary informed consent to participate 2. Age 18 to 65 3. DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID 4. Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score \>19) 5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual) 6. Stable on medications; no changes within 3 months prior to enrollment

Exclusion criteria

1. Prior CBT, SST, or CCT in the past 5 years 2. Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness \>5) 3. Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS \>8) 4. Ocular damage/disease/surgery/medications that affect pupil dilation 5. DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID 6. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .

Design outcomes

Primary

Measure	Time frame	Description
Clinical Assessment Interview for Negative Symptoms (CAINS)	baseline, 12.5 weeks	Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.

Secondary

Measure	Time frame	Description
UCSD Performance-based Skills Assessment-Brief (UPSA-B)	baseline, 12.5 weeks	Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.
Social Skills Performance Assessment (SSPA)	baseline, 12.5 weeks	Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.
Specific Levels of Functioning Scale (SLOF)	baseline, 12.5 weeks	Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.
MATRICS Consensus Cognitive Battery (MCCB)	baseline, 12.5 weeks	Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.
Defeatist Performance Attitudes Scale (DPAS)	baseline, 12.5 weeks	Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude.
Scale for the Assessment of Negative Symptoms (SANS)	baseline, 12.5 weeks	Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.
Independent Living Skills Survey (ILSS)	baseline, 12.5 weeks	Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.

Countries

United States

Participant flow

Pre-assignment details

2 participants received the wrong diagnosis, and were withdrawn from the study; 7 participants had a CAINS score of ≤19, and were excluded from the study

Participants by arm

Arm	Count
CBSST-CCT Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training CBSST-CCT	26
Goal-focused Supportive Contact Goal-focused supportive contact Goal focused supportive contact	29
Total	55

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	3
Overall Study	Withdrawal by Subject	10	10

Baseline characteristics

Characteristic	Goal-focused Supportive Contact	CBSST-CCT	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	0 Participants	1 Participants
Age, Categorical Between 18 and 65 years	28 Participants	26 Participants	54 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 7.4	47.7 years STANDARD_DEVIATION 11.4	50.6 years STANDARD_DEVIATION 9.8
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	8 Participants	18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants	18 Participants	37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	4 Participants	11 Participants	15 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	24 Participants	12 Participants	36 Participants
Region of Enrollment United States	29 participants	26 participants	55 participants
Sex: Female, Male Female	13 Participants	9 Participants	22 Participants
Sex: Female, Male Male	16 Participants	17 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 29
other Total, other adverse events	0 / 26	0 / 29
serious Total, serious adverse events	0 / 26	0 / 29

Outcome results

Primary

Clinical Assessment Interview for Negative Symptoms (CAINS)

Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.