Efficacy of ISST in Schizophrenia

NCT02678858 | Completed DMC

• 1 other identifier: ISST2015
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 6

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.

Conditions

Schizophrenia

Keywords

social cognition; social skills; cognitive remediation; functional outcome; treatment adherence

Outcome Measures

Primary Outcomes (1)

• All Cause Discontinuation

  All Cause Discontinuation is defined as 1) not keeping appointments to treatment or diagnostic sessions as scheduled for more than 6 weeks and/or (2) not being traceable despite extensive efforts by the intervention team to reengage the patient throughout the entire intended treatment period and/or (3) withdrawal of consent by the patient (4) rater induced discontinuation of the study treatment (eg. for safety criteria) (5) not taking psychotropic drugs as prescribed for more than 14 consecutive days and/or (6) relevant worsening of symptoms.

  6 months, 12 months

Secondary Outcomes (17)

• Treatment Adherence 1

  6 months, 12 months

• Treatment Adherence 2

  6 months, 12 months

• Treatment Adherence 3

  6 months, 12 months

• Psychosocial Functioning 1

  6 months, 12 months

• Psychosocial Functioning 2

  6 months, 12 months

Study Arms (2)

Integrated Social Cognitive and Behavioral Skills Therapy

EXPERIMENTAL

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.

Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy

Neurocognitive Remediation Therapy

ACTIVE COMPARATOR

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

Behavioral: Neurocognitive Remediation Therapy

Interventions

Integrated Social Cognitive and Behavioral Skills Therapy 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.

Also known as: ISST

Integrated Social Cognitive and Behavioral Skills Therapy

Neurocognitive Remediation Therapy 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.

Also known as: NCRT

Neurocognitive Remediation Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• University Hospital, Bonn: collaborator
• University Hospital of Cologne: collaborator
• University Hospital Tuebingen: collaborator
• Zentralinstitut für Seelische Gesundheit Mannheim: collaborator
• University of Cologne: collaborator
• Rheinhessen-Fachklinik Alzey: collaborator
• Vivantes Klinikum am Urban: collaborator

Study Sites (6)

Rheinhessen-Fachklinik Alzey

Alzey, Germany

Location

Vivantes Klinikum Am Urban

Berlin, Germany

Location

Dept. of Psychiatry and Psychotherapy, University of Bonn

Bonn, Germany

Location

Dept. of Psychiatry and Psychotherapy, University of Cologne

Cologne, Germany

Location

Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

Düsseldorf, Germany

Location

Dept. of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, Germany

Location

Related Publications (2)

• 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.

  PMID: 37159610 DERIVED

• 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.

  PMID: 35800017 DERIVED

MeSH Terms

Conditions

Schizophrenia; Social Skills; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior; Health Behavior

Study Officials

• Wolfgang Wölwer, Prof. Dr.

  Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

  PRINCIPAL INVESTIGATOR

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: Prof. Dr. phil.

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (6)