Trial document




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  DRKS00010033

Trial Description

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Title

Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in
Improving Functional Outcome in Schizophrenia

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Trial Acronym

ISST2015

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The ISST study investigates whether integrated social cognitive and social behavioral skills therapy is more efficacious in improving the management of the social daily routine and the compliance in therapy, than an active control treatment comprising drill and-practice oriented tasks for attention and memory.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00010033
  •   2016/03/10
  •   [---]*
  •   yes
  •   Approved
  •   5333R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   DSM-IV-TR: 295.10-30, 295.90
  •   F20 -  Schizophrenia
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Interventions/Observational Groups

  •   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.
    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, 2013) and most closely associated with functional outcome (Fett, 2011) in schizophrenia.
  •   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 Names: • NCRT
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

All Cause Discontinuation
[Time Frame: 6 months after end of treatment] [Safety Issue: No]

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.

For a more detailed assessment of adherence the following instruments are used in addition:
• SES (Service Engagement Scale, Tait, Birchwood & Trower 2002)
• DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)
• PATHEV (Psychotherapy Attitude Scale, Schulte 2005)

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Secondary Outcome

2. Psychosocial Functioning
[Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No]
measured by the
• FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009)
• UPSA-Brief (University of California Performance Based Skills Assesment, Mausbach et al. 2007)
3. Quality of Life
[Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No]
measured by:
- WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996)
4. Neurocognitive Performance
[Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No]
measured by:
• VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001)
• DSF, DSB (digit sequencing forward/backward, Wechsler 1981)
• DSST (digit symbol substitution test, Wechsler 1981)
• TMT-A, -B (Trail-Making-Test, Reitan 1956)
5. Socialcognitive Performance
[Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No]
measured by:
• PFA (Picture of Facial Affect Test, Ekman & Friesen 1976)
• MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006)
6. Psychopathology/Symptoms
[Time Frame: at begin and end of the treatment, and 6 month after end of treatment] [Safety Issue: No]
measured by:
• PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987)
• CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993)
• BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983)
7. Safety
[Time Frame: every 4-6 weeks] [Safety Issue: Yes]
Safety parameters are:
• suicide/suicide attempt
• severe suicidal crisis (CDSS Item 8 ≥ 2)
• severe symptom worsening (Clinical Global Impression Scale Item 2 ≥ 6)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/03/14
  •   180
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Written informed consent
• DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
• PANSS at baseline: total score ≤ 75
• Age between 18 and 65 years
• Proficiency in German language.
• Individualized medication according to valid treatment guidelines with up to two antipsychotic substances with flexible dosage and mode of administration within recommended dose ranges. With this medication, patients must have been treated for at least 2 weeks prior to enrollment to ensure that the maximum effect of the medication has been achieved. The addition of low- and medium-potent antipsychotic substances as a need medication for the treatment of restlessness and sleep disorders is possible, provided that the daily dosage of 150 chlorpromazine (CPZ) units is not exceeded.

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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)

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.