Efficacy of ISST in Schizophrenia

NCT02678858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2022-08-04

No results posted yet for this study

Summary

The ISST study investigates whether integrated social cognitive remediation and social behavioral skills therapy is more efficacious in improving functional outcome and treatment adherence than an active control treatment comprising drill-and-practice oriented neurocognitive remediation.

Conditions

Interventions

BEHAVIORAL

Integrated Social Cognitive and Behavioral Skills Therapy

The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) is a newly developed treatment program. It is based on the Training of Affect Recognition (Wölwer et al. 2005) and common social skills trainings, which are combined in an integrated rather than a sequenced manner. ISST uses both repeated practice and strategy-based training, and consists of 12 individual sessions, 5 group sessions and 1 individual final session over a period of 6 months.

BEHAVIORAL

Neurocognitive Remediation Therapy

The Neurocognitive Remediation Program (NCRT) is based on a neurocognitive training already used as active control condition in our earlier studies (Wölwer et al. 2005, Klingberg et al. 2011). The present version of NCRT is matched in dose, mode and scheme of application to the ISST, but differs from the ISST regarding targeted cognitive domains and preferred training strategy (predominantly drill and practice based). The NCRT provides the same amount of group interaction and companionship as well as the same amount of guided community activity as in the ISST, but is structured in such a way that interactional behavior is secondary (e.g. by competition-like tasks rather than cooperative tasks). Thus therapeutic attention and commitment are held constant across study conditions.

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER
  • University Hospital of Cologne

    collaborator OTHER
  • University Hospital Tuebingen

    collaborator OTHER
  • Zentralinstitut für Seelische Gesundheit Mannheim

    collaborator OTHER
  • University of Cologne

    collaborator OTHER
  • Rheinhessen-Fachklinik Alzey

    collaborator OTHER
  • Vivantes Klinikum am Urban

    collaborator UNKNOWN
  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Wolfgang Wölwer, Prof. Dr. · Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-02-28
Completion
2022-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678858 on ClinicalTrials.gov