Improving Real-world Function for Persons with Schizophrenia: a Single-case Experimental Design (ImproFunc)

January 17, 2025 updated by: Sykehuset Innlandet HF

Improving Real-world Function for Persons with Schizophrenia (ImproFunc): a Single-case Experimental Design

Existing treatment for individuals with psychosis primarily targets positive symptoms but has only modest effects on cognition and negative symptoms. Cognitive strategy training shows promising effects in reducing negative symptoms and increasing activity initiation in individuals with schizophrenia.

This project aims to investigate the effect of the Perceive, Recall, Plan and Perform (PRPP) intervention in promoting effective use of cognitive strategies for adults with schizophrenia in performing their daily activities. Twenty-seven individuals with schizophrenia will be recruited from Sykehuset Innlandet (Innlandet Hospital Trust) and assessed using PRPP prior to an eight-session PRPP intervention. Re-assessment will be conducted after the intervention, as well as at 3 and 6 months, to evaluate the long-term effects of the intervention. A single-case design will be used to investigate the intervention's effects. The primary outcome measure will be the PRPP assessment, and the secondary outcome measure will be the Goal Attainment Scale (GAS). Generalization measures will be used to evaluate whether there are relevant changes beyond the primary and secondary goals.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • DSM-5 diagnosis of schizophrenia, understand and speak Norwegian, live in their own community context, but are patients in Sykehuset Innlandet ( Innlandet Hospital Trust), either as outpatients or on discharge from inpatient care, a subjective experience of functional impairment and/or cognitive difficulties identified in an initial interview, and a stable state without any major medication change for at least two months before inclusion

Exclusion Criteria:

  • Major physical disability, a current substance abuse problem, and cognitive deficits of organic origin or mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Perceive, Recall, Plan and Perform intervention
Perceive, Recall, Plan and Perform (PRPP) intervention in promoting effective use of cognitive strategies for adults with schizophrenia in performing their daily activities will be given to all the included patients.
Behavioral: Perceive, Recall, Plan and Perform intervention Interventions:
The PRPP is a standardized system which determines the impact of information processing on performance of everyday activities. It is a method for assessment of performance mastery, and efficient use of cognitive strategies, as well as a model of intervention to train mastery and cognitive strategy use, in everyday activities. The PRPP assess task performance mastery, as well as cognitive strategy application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRPP assessment
Time Frame: Assesments just after the intervention, as well as at 3 and 6 months
Effective use of cognitive strategies in performing their daily activities
Assesments just after the intervention, as well as at 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Goal Attainment Scale
Time Frame: Assesments just after the intervention, as well as at 3 and 6 months
Assesments just after the intervention, as well as at 3 and 6 months
Health of the Nation Outcome Scale
Time Frame: Assesments just after the intervention, as well as at 3 and 6 months
Assesments just after the intervention, as well as at 3 and 6 months
Social Functioning Scale
Time Frame: Assesments just after the intervention, as well as at 3 and 6 months
Assesments just after the intervention, as well as at 3 and 6 months
Questionnaire about the Process of Recovery
Time Frame: Assesments just after the intervention, as well as at 3 and 6 months
Assesments just after the intervention, as well as at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Chair: Elisabeth Haug, PhD, Sykehuset Innlandet HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2031

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 798582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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