Clinical trial NCT02170051: Improving Negative Symptoms of Psychosis In Real-world Environments
Official title: Improving Negative Symptoms of Psychosis In Real-world Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: negative symptoms
cognition
functioning
defeatist attitudes
psychosocial treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-06-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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) .

Primary outcomes:
measure: Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: baseline, 12.5 weeks
Secondary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: baseline, 12.5 weeks
measure: UCSD Performance-based Skills Assessment-Brief (UPSA-B)
timeFrame: baseline, 12.5 weeks
measure: Social Skills Performance Assessment (SSPA)
timeFrame: baseline, 12.5 weeks
measure: Specific Levels of Functioning Scale (SLOF)
timeFrame: baseline, 12.5 weeks
measure: Independent Living Skills Survey (ILSS)
timeFrame: baseline, 12.5 weeks
measure: Defeatist Performance Attitudes Scale (DPAS)
timeFrame: baseline, 12.5 weeks
measure: Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: baseline, 12.5 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: Elizabeth Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Eric Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126.