Efficacy of "Integrated Social Cognitive and Behavioral Skills Therapy" (ISST) in Improving Functional Outcome in Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 177
- Locations
- 6
- Primary Endpoint
- All Cause Discontinuation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Wolfgang Wölwer
Prof. Dr. phil.
Heinrich-Heine University, Duesseldorf
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)
Outcomes
Primary Outcomes
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 Outcomes
- WHOQUOL-Bref (Quality of Life)(6 months, 12 months)
- Treatment Adherence 2(6 months, 12 months)
- Treatment Adherence 1(6 months, 12 months)
- Neurocognitive Performance (working memory)(6 months, 12 months)
- Neurocognitive Performance (processing speed 1)(6 months, 12 months)
- Psychosocial Functioning 2(6 months, 12 months)
- Socialcognitive Performance (affect recognition)(6 months, 12 months)
- Psychopathology/Symptoms 1(6 months, 12 months)
- Neurocognitive Performance (processing speed 2)(6 months, 12 months)
- Treatment Adherence 3(6 months, 12 months)
- Psychosocial Functioning 1(6 months, 12 months)
- Neurocognitive Performance (verbal memory)(6 months, 12 months)
- Socialcognitive Performance (theory of mind)(6 months, 12 months)
- Psychopathology/Symptoms 2(6 months, 12 months)
- Psychopathology/Symptoms 3(6 months, 12 months)
- Severe symptom worsening(Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first))
- Suicidality(Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first))