AzTrials
AzTrials

SchizophreniaNCT02678858

Efficacy of ISST in Schizophrenia

A study testing Integrated Social Cognitive and Behavioral Skills Therapy and Neurocognitive Remediation Therapy in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Integrated Social Cognitive and Behavioral Skills Therapy and Neurocognitive Remediation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
6 sitesGermany
Study dates
Mar 2016to Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
  • PANSS at baseline: total score ≤ 75
  • Proficiency in German language.

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Rheinhessen-Fachklinik Alzey

    Alzey

  • Vivantes Klinikum Am Urban

    Berlin

  • Dept. of Psychiatry and Psychotherapy, University of Bonn

    Bonn

  • Dept. of Psychiatry and Psychotherapy, University of Cologne

    Cologne

  • Dept. of Psychiatry and Psychotherapy, University of Düsseldorf

    Düsseldorf

  • Dept. of Psychiatry and Psychotherapy, University of Tübingen

    Tübingen

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Schizophrenia
Being tested
Integrated Social Cognitive and Behavioral Skills Therapy, Neurocognitive Remediation Therapy
Keywords
social cognition, social skills, cognitive remediation, functional outcome, treatment adherence
Medical subject headings
Schizophrenia, Social Skills, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Social Cognitive and Behavioral Skills TherapyBehavioural

    Also called ISST

    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 TherapyBehavioural

    Also called NCRT

    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.

Study groups in NCT02678858
Study groupRoleWhat they receive
Integrated Social Cognitive and Behavioral Skills TherapyExperimentalThe 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.
Receives: Behavioral: Integrated Social Cognitive and Behavioral Skills Therapy
Neurocognitive Remediation TherapyActive comparatorThe Neurocognitive Remediation Therapy (NCRT) shall target impairments in attention, memory, and executive functions as an active comparator to the ISST.
Receives: Behavioral: Neurocognitive Remediation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months, 12 months

Secondary outcomes (17)

  1. Treatment Adherence 1

    SES (Service Engagement Scale, Tait, Birchwood \& Trower 2002)

    Measured: 6 months, 12 months

  2. Treatment Adherence 2

    DAI-10 (Drug Attitude Scale, Goodstadt et al. 1978)

    Measured: 6 months, 12 months

  3. Treatment Adherence 3

    PATHEV (Psychotherapy Attitude Scale, Schulte 2005)

    Measured: 6 months, 12 months

  4. Psychosocial Functioning 1

    FROGS (Functional Remission of General Schizophrenia, Lorca et al. 2009)

    Measured: 6 months, 12 months

  5. Psychosocial Functioning 2

    UPSA-Brief (University of California Performance Based Skills Assessment, Mausbach et al. 2007)

    Measured: 6 months, 12 months

  6. WHOQUOL-Bref (Quality of Life)

    WHOQUOL-BREF (World Health Organization Quality of Life, WHO 1996)

    Measured: 6 months, 12 months

  7. Neurocognitive Performance (verbal memory)

    VLMT (verbal learning and memory test, Helmstaedter, Lendt \& Lux 2001

    Measured: 6 months, 12 months

  8. Neurocognitive Performance (working memory)

    DSF, DSB (digit sequencing forward/backward, Wechsler 1981)

    Measured: 6 months, 12 months

  9. Neurocognitive Performance (processing speed 1)

    DSST (digit symbol substitution test, Wechsler 1981)

    Measured: 6 months, 12 months

  10. Neurocognitive Performance (processing speed 2)

    TMT-A, -B (Trail-Making-Test, Reitan 1956)

    Measured: 6 months, 12 months

  11. Socialcognitive Performance (affect recognition)

    PFA (Picture of Facial Affect Test, Ekman \& Friesen 1976)

    Measured: 6 months, 12 months

  12. Socialcognitive Performance (theory of mind)

    MASC (Movie for the Assessment of Social Cognition, Dziobek et al. 2006)

    Measured: 6 months, 12 months

  13. Psychopathology/Symptoms 1

    PANSS (Positive and Negative Syndrome Scale, Kay, Fiszbein \& Opler 1987)

    Measured: 6 months, 12 months

  14. Psychopathology/Symptoms 2

    CDSS (Calgary Depression Rating Scale for Schizophrenia, Addington, Addington \& Maticka-Tyndale 1993)

    Measured: 6 months, 12 months

  15. Psychopathology/Symptoms 3

    BSI (Brief Symptom Inventory, Derogatis \& Melisaratos 1983)

    Measured: 6 months, 12 months

  16. Suicidality

    Incidence of suicide/suicide attempt or severe suicidal crisis (CDSS Item 8 ≥ 2)

    Measured: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)

  17. Severe symptom worsening

    CGI (Clinical Global Impression Scale Item 2 ≥ 6)

    Measured: Assessed every 4-6 weeks from date of randomization until 1 year or until discontinuation (whatever came first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionFeb 2021
  4. Study completionMar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02678858
Sponsor's protocol ID
ISST2015
Status last verified
Aug 2022
First submitted
3 Feb 2016
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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").

Publications

  • Schuster T, Lowe A, Weide K, Kamp D, Riesbeck M, Bechdolf A, Brockhaus-Dumke A, Hurlemann R, Muthesius A, Klingberg S, Hellmich M, Schmied S, Meyer-Lindenberg A, Wolwer W; ISST study group. Feasibility of six-month outpatient cognitive remediation in schizophrenia: Experience from the randomized controlled integrated social cognition and social skills therapy study. Schizophr Res Cogn. 2023 Apr 27;33:100285. doi: 10.1016/j.scog.2023.100285. eCollection 2023 Sep.

    PubMed 37159610

  • 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.

    PubMed 35800017

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Social Cognitive and Behavioral Skills Therapy and Neurocognitive Remediation Therapy in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause Discontinuation (time frame: 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02678858, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in