NCT02170051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

4.2 years

First QC Date

June 18, 2014

Results QC Date

November 2, 2020

Last Update Submit

April 29, 2021

Conditions

Schizophrenia

Keywords

negative symptomscognitionfunctioningdefeatist attitudespsychosocial treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 12.5 weeks

Secondary Outcomes (7)

  • MATRICS Consensus Cognitive Battery (MCCB)

    baseline, 12.5 weeks

  • UCSD Performance-based Skills Assessment-Brief (UPSA-B)

    baseline, 12.5 weeks

  • Social Skills Performance Assessment (SSPA)

    baseline, 12.5 weeks

  • Specific Levels of Functioning Scale (SLOF)

    baseline, 12.5 weeks

  • Independent Living Skills Survey (ILSS)

    baseline, 12.5 weeks

  • +2 more secondary outcomes

Study Arms (2)

CBSST-CCT

EXPERIMENTAL

Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Behavioral: CBSST-CCT

Goal-focused supportive contact

ACTIVE COMPARATOR

Goal-focused supportive contact

Behavioral: Goal focused supportive contact

Interventions

CBSST-CCTBEHAVIORAL
Also known as: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
CBSST-CCT
Goal focused supportive contactBEHAVIORAL
Goal-focused supportive contact

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 34665853DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

High participant dropout rate, leading to a smaller number of subjects analyzed than anticipated.

Results Point of Contact

Title
Elizabeth W Twamley, PhD
Organization
Professor of Psychiatry, UC San Diego
etwamley@health.ucsd.edu
858-642-3848

Study Officials

  • Elizabeth Twamley, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

  • Eric Granholm, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 23, 2014

Study Start

July 1, 2014

Primary Completion

September 3, 2018

Study Completion

September 3, 2018

Last Updated

May 19, 2021

Results First Posted

November 27, 2020

Record last verified: 2021-04

Locations

US(1)