Efficacy of ISST in Schizophrenia

NCT ID: NCT02678858

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2022-03-31

Brief 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.

Detailed Description

Deficits in social functioning are a defining, very burdening feature of schizophrenia precluding patients from participating in a satisfying life. Traditional drug and psychosocial therapy and available specific treatment strategies that directly target single key determinants of functional outcome like neurocognition, social cognition, and social behavioral skills have produced only moderate effects leaving an urgent need for further optimization. The present trial aims to more efficaciously improve functional outcome by integrating social behavioral and social cognitive treatment strategies. Six months of "Integrated Social Cognitive and Behavioral Skills Therapy (ISST)" will be compared with "Neurocognitive Remediation Therapy (NCRT)" as active control condition in a randomized multicenter clinical trial using a two group pre-post design with 2x90 patients in the remitted early phase of schizophrenia. Beyond "all-cause-discontinuation" as common primary outcome of all clinical trials of the ESPRIT-consortium, measures of functional outcome and subjective quality of life, patient experience as well as neurocognitive, social-cognitive and social behavioral measures will be assessed at baseline (V0), after completion of treatment (V6), and after 6 months follow-up (V12). ISST is expected to reduce the one-year discontinuation rate by 20% compared with NCRT, and to be superior in functional outcome measures by an effect size of at least d=0.42.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Integrated Social Cognitive and Behavioral Skills Therapy

The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) shall target expressive and interactional behavior skills together with those social cognitive domains (facial and prosodic affect recognition, social perception, theory-of-mind) known to be most impaired (Savla, 2012) and most closely associated with functional outcome (Fett, 2012) in schizophrenia.

Group Type: EXPERIMENTAL

Integrated Social Cognitive and Behavioral Skills Therapy

Intervention Type: BEHAVIORAL

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.

Neurocognitive Remediation Therapy

The Neurocognitive Remediation Therapy (NCRT) shall target impairments in attention, memory, and executive functions as an active comparator to the ISST.

Group Type: ACTIVE_COMPARATOR

Neurocognitive Remediation Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ISST; NCRT

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
• PANSS at baseline: total score ≤ 75
• Proficiency in German language.

Exclusion Criteria

• Lack of accountability
• Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
• Serious suicidal risk at screening visit
• Other relevant axis 1-diagnoses according to diagnostic interview (MINI);
• Other relevant neurological or somatic disorders
• Verbal IQ<80 (MWT-B)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: collaborator

University Hospital of Cologne

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Zentralinstitut für Seelische Gesundheit Mannheim

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

Rheinhessen-Fachklinik Alzey

OTHER

Sponsor Role: collaborator

Vivantes Klinikum am Urban

UNKNOWN

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Wölwer

Prof. Dr. phil.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Wölwer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

Locations

Rheinhessen-Fachklinik Alzey

Alzey, , Germany

Vivantes Klinikum Am Urban

Berlin, , Germany

Dept. of Psychiatry and Psychotherapy, University of Bonn

Bonn, , Germany

Dept. of Psychiatry and Psychotherapy, University of Cologne

Cologne, , Germany

Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

Düsseldorf, , Germany

Dept. of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, , Germany

Countries

Germany

References

Schuster T, Lowe A, Weide K, Kamp D, Riesbeck M, Bechdolf A, Brockhaus-Dumke A, Hurlemann R, Muthesius A, Klingberg S, Hellmich M, Schmied S, Meyer-Lindenberg A, Wolwer W; ISST study group. Feasibility of six-month outpatient cognitive remediation in schizophrenia: Experience from the randomized controlled integrated social cognition and social skills therapy study. Schizophr Res Cogn. 2023 Apr 27;33:100285. doi: 10.1016/j.scog.2023.100285. eCollection 2023 Sep.

Reference Type: DERIVED

PMID: 37159610 (View on PubMed)

Wolwer W, Frommann N, Lowe A, Kamp D, Weide K, Bechdolf A, Brockhaus-Dumke A, Hurlemann R, Muthesius A, Klingberg S, Hellmich M, Schmied S, Meyer-Lindenberg A; ISST study group. Efficacy of Integrated Social Cognitive Remediation vs. Neurocognitive Remediation in Improving Functional Outcome in Schizophrenia: Concept and Design of a Multicenter, Single-Blind RCT (The ISST Study). Front Psychiatry. 2022 Jun 21;13:909370. doi: 10.3389/fpsyt.2022.909370. eCollection 2022.

Reference Type: DERIVED

PMID: 35800017 (View on PubMed)

Other Identifiers

ISST2015

Identifier Type: -

Identifier Source: org_study_id