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Pilot evaluation of modified cognitive behavioral therapy for elderly patients with schizophrenia

Pilot evaluation of modified cognitive behavioral therapy for elderly patients with schizophrenia - Edlerly Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003623
Enrollment
42
Registered
2012-03-27
Start date
2012-04-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-IV 295.30 Schizophrenia, paranoid type DSM-IV 295.10 Schizophrenia disorganized type DSM-IV 295.90 Schizophrenia undifferentiated type DSM-IV 295.60 Schizophrenia residual type DSM-IV 295.40 Schizophreniform disorder DSM-IV 295.70 Schizoaffective disorder DSM-IV 197.1 Delusional disorder F20 F25 F22

Interventions

Group 1: modified behavioural psychotherapy: Activation and cognitive encouragement, social skills training, problem solving. Intervention strategies are adapted for the needs of elderly subjects with

Sponsors

Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Klinik der Universität Duisburg-Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: DSM-IV Schizophrenia diagnosis: 295.30, 295.10, 295.9, 295.60, 295.40, 295.70, 297.1; illness duration > 10 years; MWT-B IQ > 75; physical ability for self-initiated activities; psychic stability for outpatient treatment; fluency of German language; contact person with >/= 10 h contacts / week; travel time to study site < 1 hour

Exclusion criteria

Exclusion criteria: Dementia; unsuccessfully treated diabetes; dependency or substance abuse of psychoactive substances which needs to be treated; Stroke or acute or chronic heart disease within 3 month before inclusion into the study; chronic nervous system related inflammation; malign tumor, major depression (severe)

Design outcomes

Primary

MeasureTime frame
Improvement in one of three: 1. Symptoms: Positive and negative syndrom scale (PANSS) total score: Structured Interview on symptoms in schizophrenia; 2. Depression symptoms: Calgary Depression Rating Scale for Schizophrenia German Version (CDSS-G), Questionaire to be conducted by study participants 3. Functional abilities: UPSA-Brief - University of California, San Diego, Performance-Based Skills Assessment, Rating of study participants behaviour in simple tasks related to standardized situations. Primary endpoints are assessed following randomization (before treatment start), following 4.5 month in the study, following 9 month in the study (treatment end) and following 15 month in the study (6 month follow-up). Outcome no. 3 is not assessed at 4.5 month.

Secondary

MeasureTime frame
1. STAI trait: State-trait Anxiety Inventory; Fragebogen / Questionaire 2. GAF: global assessement of functioning, Klinische Beurteilung / Rating 3. CERADplus: Consortium to Establish a Registry for Alzheimer’s Disease; neuropsychological assessement 4. ZST: Digit-Symbol-Test, neuropsychological assessment; WHOQOL BREF+OLD: WHO measure of quality of life (german short form and version for elderly subjects) 5. Activities of Dailly Living: Nürnberger Altersinventar, Questionaire 6. SUMD: Scale to assess unawareness of mental disorder; Questionaire 7. Lubben Social Network Scale, Fremd-Rating / structured Interview 8: Documentation of rater blindness to the subjects treatment arm (single blindness protocoll) Only the investigator conducting the psychotherapeutic intervention needs to know the randomization status of the patient. 9: MWT-B: Mehrfachwahl-Wortschatz-Intelligenztest, neuropsychological assessment of premorbid education 10: Blood sample (experimental assessment of probable indicators of neurodegenerative diseases, results not be be communicated to study participants) Outcomes 1-8 are assessed before treatment, at the end of treatment (9 month) and at 6 month follow-up. Outcomes 9 and 10 are assessed before randomisation. Following 4.5 month in the study outcomes 1, 2 and 8 are assessed.

Countries

Germany

Contacts

Public ContactBernhard Müller

Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Klinik der Universität Duisburg-Essen / Clinic for Psychiatry and Psychotherapy, University of Duisburg-Essen

bernhard.mueller@uni-due.de+49 201 9597016

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026