Efficacy of ISST in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678858
• Other study ID #: ISST2015
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2022

Study information

• Verified date: August 2022
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Rheinhessen-Fachklinik Alzey	Alzey
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Dept. of Psychiatry and Psychotherapy, University of Bonn	Bonn
Germany	Dept. of Psychiatry and Psychotherapy, University of Cologne	Cologne
Germany	Dept. of Psychiatry and Psychotherapy, University of Düsseldorf	Duesseldorf
Germany	Dept. of Psychiatry and Psychotherapy, University of Tübingen	Tübingen

Sponsors (8)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Rheinhessen-Fachklinik Alzey, University Hospital of Cologne, University Hospital Tuebingen, University Hospital, Bonn, University of Cologne, Vivantes Klinikum am Urban, Zentralinstitut für Seelische Gesundheit Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment Adherence 1	SES (Service Engagement Scale, Tait, Birchwood & Trower 2002)	6 months, 12 months
Secondary	Treatment Adherence 2	DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)	6 months, 12 months
Secondary	Treatment Adherence 3	PATHEV (Psychotherapy Attitude Scale, Schulte 2005)	6 months, 12 months
Secondary	Psychosocial Functioning 1	FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009)	6 months, 12 months
Secondary	Psychosocial Functioning 2	UPSA-Brief (University of California Performance Based Skills Assessment, Mausbach et al. 2007)	6 months, 12 months
Secondary	WHOQUOL-Bref (Quality of Life)	WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996)	6 months, 12 months
Secondary	Neurocognitive Performance (verbal memory)	VLMT (verbal learning and memory test, Helmstaedter, Lendt & Lux 2001	6 months, 12 months
Secondary	Neurocognitive Performance (working memory)	DSF, DSB (digit sequencing forward/backward, Wechsler 1981)	6 months, 12 months
Secondary	Neurocognitive Performance (processing speed 1)	DSST (digit symbol substitution test, Wechsler 1981)	6 months, 12 months
Secondary	Neurocognitive Performance (processing speed 2)	TMT-A, -B (Trail-Making-Test, Reitan 1956)	6 months, 12 months
Secondary	Socialcognitive Performance (affect recognition)	PFA (Picture of Facial Affect Test, Ekman & Friesen 1976)	6 months, 12 months
Secondary	Socialcognitive Performance (theory of mind)	MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006)	6 months, 12 months
Secondary	Psychopathology/Symptoms 1	PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein & Opler 1987)	6 months, 12 months
Secondary	Psychopathology/Symptoms 2	CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington & Maticka-Tyndale 1993)	6 months, 12 months
Secondary	Psychopathology/Symptoms 3	BSI (Brief Symptom Inventory, Derogatis & Melisaratos 1983)	6 months, 12 months
Secondary	Suicidality	Incidence of suicide/suicide attempt or severe suicidal crisis (CDSS Item 8 = 2)	Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)
Secondary	Severe symptom worsening	CGI (Clinical Global Impression Scale Item 2 = 6)	Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)