Skip to content

Nursing Interventions to Improve Functional Outcome in Patients with Severe Mental Illness (NISMI).

Cognitive Adaptation Training: A randomized controlled trial to improve functional outcome in chronic hospitalized patients with schizophrenia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27298
Enrollment
130
Registered
2012-02-26
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Severe mental illnesses encompass schizophrenia, schizo-affective disorders, and major depression. The majority of the patients at the participating clinic are diagnosed with schizophrenia.

Interventions

Treatment plans that include cognitive adaptation training are based on two dimensions: 1. The patient’s level of apathy versus disinhibition
2. The patient’s level of impairment in executive functions. Behaviors characterized by apathy can be altered by providing prompting and cueing that help the patient initiate each step in a sequence

Sponsors

-University of Groningen, University Medical Center Groningen, The Netherlands -Lentis research, Linis Mental Health Institute, Groningen, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: No inclusion criteria will be held with regard to specific diagnosis. Inclusion criteria are age > 18, suffering from a severe mental illness and living at a long-term clinical health facility.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
The study will include a baseline measurement (T0) and follow-up assessments (T3, T6, T9, T12, T18 en T24; T=assessment month). During all assessments, the primary instruments will be included, consisting of the Personal and Social Performance scale (PSP), and the Multnomah Community Ability Scale (MCAS), both instruments focusing on daily functioning. It is expected that the PSP (the new version of the GAF-D) will be the most sensitive for change in daily functioning. Recent studies by Velligan et al. (2008) have shown effect sizes of Cohen's D > 1.0, on such measures. The MCAS is a semi-structured interview that is also being used during the CAT in America. The MCAS contains 17 items on domains focusing on interference with functioning, self efficacy, social competence, and behavioral problems. Assessment of the MCAS and PSP will take 45 minutes to complete. 25-jun-2014: Instead of with the PSP, we administer the Social and Occupationial Functioning Scale (SOFAS; APA, 2000). Furthermore, we added observational questionnaires to be filled out by the case manager of the participant (the Life Skills Profile and the Social Functioning Scale).

Secondary

MeasureTime frame
Secondary outcome measures will be assessed at baseline (T0), halfway (T12) and at the end of the study (T24). The measures will consist of (i) observational skills of nurses, (ii) performance-based tasks, (iii) clinical symptoms, (iv) job satisfaction, and (v) empowerment. Observational skills will be assessed in nurses, to investigate whether they are better able to recognize cognitive impairments after being teached how to provide their patients with CAT. During 45 minutes, a number of cases will be presented plenary, by means of video demonstrations. The video's will present cases with differing cognitive profiles, as performed by actors. The Schizophrenia Cognitive Rating Scale (SCoRS), a commonly used international instrument to observe and quantify cognitive deficits, will be used by nurses to rate the cognitive deficits of the cases. Performance-based tasks will consist of measures of cognitive functioning and functional capacity. Cognitive tasks will be assessed using the Brief Assessment of Cognition in Schizophrenia, or a battery with similar measures. Functional Capacity will be assessed using the University of California Performance-based Skills Assessment - Brief version (UPSA-B). Assessment of the BACS and UPSA-B will take 45 minutes to complete. Clinical symptoms will be interviewed using the Positive And Negative Syndrome Scale (PANSS). The PANSS is the most widely used scale to measure current severity of positive symptoms, negative symptoms, disorganization, mania and depression. Assessment will take 40 minutes to complete. Work satisfaction in nurses will be evaluated using the Occupational Stress Indicator (OSI). Empowerment in patients will be assessed using the Dutch Empowerment Questionnaire (Nederlandse Empowerment Vragenlijst or NEL). To test feasibility of CAT, we will assess the CAT therapists with the Quality Assurance Measures Form (QAMF). The QAMF evaluates whether therapists give their interventions in line with the CAT guidelines. Th

Contacts

Public ContactPiotr J. Quee

Department of Psychiatry & Rob Giel Research Center University Medical Center Groningen P.O.Box 30.001 (CC72)

p.j.quee@umcg.nl+31 (0)50 3612034

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)