Clinical trial NCT02678858: Efficacy of ISST in Schizophrenia
Official title: Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: social cognition
social skills
cognitive remediation
functional outcome
treatment adherence
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: University Hospital, Bonn
name: University Hospital of Cologne
name: University Hospital Tuebingen
name: Zentralinstitut für Seelische Gesundheit Mannheim
name: University of Cologne
name: Rheinhessen-Fachklinik Alzey
name: Vivantes Klinikum am Urban
First posted: 2016-02-10
Enrollment: 177
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: 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.

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)

Primary outcomes:
measure: All Cause Discontinuation
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Treatment Adherence 1
timeFrame: 6 months, 12 months
measure: Treatment Adherence 2
timeFrame: 6 months, 12 months
measure: Treatment Adherence 3
timeFrame: 6 months, 12 months
measure: Psychosocial Functioning 1
timeFrame: 6 months, 12 months
measure: Psychosocial Functioning 2
timeFrame: 6 months, 12 months
measure: WHOQUOL-Bref (Quality of Life)
timeFrame: 6 months, 12 months
measure: Neurocognitive Performance (verbal memory)
timeFrame: 6 months, 12 months
measure: Neurocognitive Performance (working memory)
timeFrame: 6 months, 12 months
measure: Neurocognitive Performance (processing speed 1)
timeFrame: 6 months, 12 months
measure: Neurocognitive Performance (processing speed 2)
timeFrame: 6 months, 12 months
measure: Socialcognitive Performance (affect recognition)
timeFrame: 6 months, 12 months
measure: Socialcognitive Performance (theory of mind)
timeFrame: 6 months, 12 months
measure: Psychopathology/Symptoms 1
timeFrame: 6 months, 12 months
measure: Psychopathology/Symptoms 2
timeFrame: 6 months, 12 months
measure: Psychopathology/Symptoms 3
timeFrame: 6 months, 12 months
measure: Suicidality
timeFrame: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)
measure: Severe symptom worsening
timeFrame: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)
Other outcomes:
Locations:
city: Alzey
country: Germany
facility: Rheinhessen-Fachklinik Alzey
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bonn
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, University of Bonn
city: Cologne
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, University of Cologne
city: Duesseldorf
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, University of Düsseldorf
city: Tübingen
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, University of Tübingen
Study officials:
affiliation: Dept. of Psychiatry and Psychotherapy, University of Düsseldorf
name: Wolfgang Wölwer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.