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Efficacy of ISST in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02678858
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
University Hospital, Bonn
University Hospital of Cologne
University Hospital Tuebingen
Zentralinstitut für Seelische Gesundheit Mannheim
University of Cologne
Rheinhessen-Fachklinik Alzey
Vivantes Klinikum Am Urban, Berlin
Information provided by (Responsible Party):
Wolfgang Wölwer, Heinrich-Heine University, Duesseldorf

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy Behavioral: Neurocognitive Remediation Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia
Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: ISST

Active Comparator: Neurocognitive Remediation Therapy
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
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.
Other Name: NCRT




Primary Outcome Measures :
  1. All Cause Discontinuation [ Time Frame: 6 months, 12 months ]
    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.


Secondary Outcome Measures :
  1. Treatment Adherence 1 [ Time Frame: 6 months, 12 months ]
    SES (Service Engagement Scale, Tait, Birchwood & Trower 2002)

  2. Treatment Adherence 2 [ Time Frame: 6 months, 12 months ]
    DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)

  3. Treatment Adherence 3 [ Time Frame: 6 months, 12 months ]
    PATHEV (Psychotherapy Attitude Scale, Schulte 2005)

  4. Psychosocial Functioning 1 [ Time Frame: 6 months, 12 months ]
    FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009)

  5. Psychosocial Functioning 2 [ Time Frame: 6 months, 12 months ]
    UPSA-Brief (University of California Performance Based Skills Assessment, Mausbach et al. 2007)

  6. Quality of Life [ Time Frame: 6 months, 12 months ]
    WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996)

  7. Neurocognitive Performance (verbal memory) [ Time Frame: 6 months, 12 months ]
    VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001

  8. Neurocognitive Performance (working memory) [ Time Frame: 6 months, 12 months ]
    DSF, DSB (digit sequencing forward/backward, Wechsler 1981)

  9. Neurocognitive Performance (processing speed 1) [ Time Frame: 6 months, 12 months ]
    DSST (digit symbol substitution test, Wechsler 1981)

  10. Neurocognitive Performance (processing speed 2) [ Time Frame: 6 months, 12 months ]
    TMT-A, -B (Trail-Making-Test, Reitan 1956)

  11. Socialcognitive Performance (affect recognition) [ Time Frame: 6 months, 12 months ]
    PFA (Picture of Facial Affect Test, Ekman & Friesen 1976)

  12. Socialcognitive Performance (theory of mind) [ Time Frame: 6 months, 12 months ]
    MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006)

  13. Psychopathology/Symptoms 1 [ Time Frame: 6 months, 12 months ]
    PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987)

  14. Psychopathology/Symptoms 2 [ Time Frame: 6 months, 12 months ]
    CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993)

  15. Psychopathology/Symptoms 3 [ Time Frame: 6 months, 12 months ]
    BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983)

  16. Suicidality [ Time Frame: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) ]
    Incidence of suicide/suicide attempt or severe suicidal crisis (CDSS Item 8 ≥ 2)

  17. Severe symptom worsening [ Time Frame: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first) ]
    CGI (Clinical Global Impression Scale Item 2 ≥ 6)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678858


Contacts
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Contact: Wolfgang Wölwer, Prof. Dr. woelwer@uni-duesseldorf.de

Locations
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Germany
Rheinhessen-Fachklinik Alzey Recruiting
Alzey, Germany
Contact: Anke Brockhaus-Dumke, PD Dr.       a.brockhaus-dumke@rfk.landeskrankenhaus.de   
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany
Contact: Andreas Bechdolf, Prof. Dr.       Andreas.Bechdolf@vivantes.de   
Dept. of Psychiatry and Psychotherapy, University of Bonn Recruiting
Bonn, Germany
Contact: Alexandra Philipsen, Prof. Dr.       Alexandra.Philipsen@ukbonn.de   
Dept. of Psychiatry and Psychotherapy, University of Cologne Recruiting
Cologne, Germany
Contact: Joseph Kambeitz, Prof. Dr.       Joseph.kambeitz@uk-koeln.de   
Dept. of Psychiatry and Psychotherapy, University of Düsseldorf Recruiting
Duesseldorf, Germany
Contact: Wolfgang Wölwer, Prof. Dr.       woelwer@uni-duesseldorf.de   
Dept. of Psychiatry and Psychotherapy, University of Tübingen Recruiting
Tübingen, Germany
Contact: Stefan Klingberg, Prof. Dr.       stefan.klingberg@med.uni-tuebingen.de   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
University Hospital, Bonn
University Hospital of Cologne
University Hospital Tuebingen
Zentralinstitut für Seelische Gesundheit Mannheim
University of Cologne
Rheinhessen-Fachklinik Alzey
Vivantes Klinikum Am Urban, Berlin
Investigators
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Principal Investigator: Wolfgang Wölwer, Prof. Dr. Dept. of Psychiatry and Psychotherapy, University of Düsseldorf
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Responsible Party: Wolfgang Wölwer, Prof. Dr. phil., Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02678858    
Other Study ID Numbers: ISST2015
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data shall be shared within the German research network ESPRIT (Enhancing Schizophrenia Prevention and Recovery through Innovative Treatments) as well as with other German research networks funded by the BMBF (call "Psychische Erkrankungen").
Keywords provided by Wolfgang Wölwer, Heinrich-Heine University, Duesseldorf:
social cognition
social skills
cognitive remediation
functional outcome
treatment adherence
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders