NCT02170051: INSPIRE

Improving Negative Symptoms of Psychosis In Real-world Environments

Completed NA Results posted Last updated 19 May 2021

What this trial tests

NA trial testing CBSST-CCT in Schizophrenia in 64 participants. Completed in 3 September 2018.

Timeline

1 July 2014

Primary endpoint
3 September 2018

3 September 2018

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	64
Start date	1 July 2014
Primary completion	3 September 2018
Estimated completion	3 September 2018
Sites	1 location across United States

Drugs / interventions tested

• CBSST-CCT
• Goal focused supportive contact

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Assessment Interview for Negative Symptoms (CAINS) Primary · baseline, 12.5 weeks

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

Group	Value	95% CI
CBSST-CCT	.0667	± 4.02611
Goal-focused Supportive Contact	-.0588	± 5.85737

MATRICS Consensus Cognitive Battery (MCCB) Secondary · 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.

Group	Value	95% CI
CBSST-CCT	.8778	± 3.40143
Goal-focused Supportive Contact	-.0065	± 2.87904

UCSD Performance-based Skills Assessment-Brief (UPSA-B) Secondary · baseline, 12.5 weeks

Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.

Group	Value	95% CI
CBSST-CCT	3.1667	± 13.91000
Goal-focused Supportive Contact	1.3882	± 10.42682

Social Skills Performance Assessment (SSPA) Secondary · baseline, 12.5 weeks

Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.

Group	Value	95% CI
CBSST-CCT	.1824	± .56812
Goal-focused Supportive Contact	.0548	± .43854

Specific Levels of Functioning Scale (SLOF) Secondary · baseline, 12.5 weeks

Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.

Group	Value	95% CI
CBSST-CCT	.1718	± .38527
Goal-focused Supportive Contact	.2498	± .63886

Independent Living Skills Survey (ILSS) Secondary · baseline, 12.5 weeks

Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.

Group	Value	95% CI
CBSST-CCT	.0121	± .04379
Goal-focused Supportive Contact	-.0078	± .06717

Defeatist Performance Attitudes Scale (DPAS) Secondary · 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.

Group	Value	95% CI
CBSST-CCT	-3.8667	± 11.01860
Goal-focused Supportive Contact	1.1765	± 19.38825

Scale for the Assessment of Negative Symptoms (SANS) Secondary · baseline, 12.5 weeks

Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.

Group	Value	95% CI
CBSST-CCT	-.8000	± 2.45531
Goal-focused Supportive Contact	-.1176	± 2.95555

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive behavioural therapy plus standard care versus standard care plus other psychosocial treatments for people with schizophrenia.
   Jones C, Hacker D, Meaden A, Cormac I, et al · · 2018 · cited 37× · PMID 30480760 · DOI 10.1002/14651858.cd008712.pub3
2. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial.
   Granholm E, Twamley EW, Mahmood Z, Keller AV, et al · · 2022 · cited 16× · PMID 34665853 · DOI 10.1093/schbul/sbab126
3. Reducing negative symptoms in schizophrenia: Feasibility and acceptability of a combined cognitive-behavioral social skills training and compensatory cognitive training intervention.
   Mahmood Z, Van Patten R, Keller AV, Lykins HC, et al · · 2021 · cited 10× · PMID 33290939 · DOI 10.1016/j.psychres.2020.113620
4. Modifiable predictors of self-reported and performance-based functioning in individuals with schizophrenia-spectrum disorders and high levels of negative symptoms.
   Mahmood Z, Parrish EM, Keller AV, Lykins HC, et al · · 2022 · cited 5× · PMID 35533518 · DOI 10.1016/j.jpsychires.2022.04.039