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SchizophreniaImproFuncNCT06790186

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

A study testing Perceive, Recall, Plan and Perform intervention Interventions: in people with Schizophrenia, run by Sykehuset Innlandet HF.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Schizophrenia
What is being tested?
Perceive, Recall, Plan and Perform intervention Interventions:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
1 Feb 2025to 31 Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Elisabeth Haug, PhD contact

0047 95781487

elisabeth.haug@sykehuset-innlandet.no

Pia Marie Reinfjord Johnsen, PhD candidate contact

0047 95761673

pia.Johnsen@sykehuset-innlandet.no

About this study

Official title: 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.

Conditions
Schizophrenia
Being tested
Perceive, Recall, Plan and Perform intervention Interventions:
Keywords
Cognitive difficulties
Medical subject headings
Schizophrenia

What participants receive

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

  • Perceive, Recall, Plan and Perform intervention Interventions:Behavioural

    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

Study groups in NCT06790186
Study groupRoleWhat they receive
Perceive, Recall, Plan and Perform interventionOtherPerceive, 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.
Receives: Behavioral: Perceive, Recall, Plan and Perform intervention Interventions:

What is being measured

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

  1. PRPP assessment

    Effective use of cognitive strategies in performing their daily activities

    Measured: Assesments just after the intervention, as well as at 3 and 6 months

Secondary outcomes (4)

  1. Goal Attainment Scale

    Measured: Assesments just after the intervention, as well as at 3 and 6 months

  2. Health of the Nation Outcome Scale

    Measured: Assesments just after the intervention, as well as at 3 and 6 months

  3. Social Functioning Scale

    Measured: Assesments just after the intervention, as well as at 3 and 6 months

  4. Questionnaire about the Process of Recovery

    Measured: Assesments just after the intervention, as well as at 3 and 6 months

Timeline

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

  1. First posted23 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Jan 2031 (estimated)

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
Not applicable
Intervention model
Single group
Model description
Perceive, Recall, Plan and Perform (PRPP) intervention, to promote effective use of cognitive strategies for adults with schizophrenia when performing everyday activities in a real-world context. 27 persons with cognitive impairment due to schizophrenia will be included and provided the PRPP intervention in eight sessions. A single case experimental design with multiple baselines will be used to investigate the effectiveness of the PRPP intervention.
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790186
Sponsor's protocol ID
798582
Acronym
ImproFunc
Status last verified
Nov 2024
First submitted
17 Jan 2025
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aydin O. Rise of single-case experimental designs: A historical overview of the necessity of single-case methodology. Neuropsychol Rehabil. 2024 Apr;34(3):301-334. doi: 10.1080/09602011.2023.2181191. Epub 2023 Feb 22.

    PubMed 36811612

  • Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

    PubMed 29253607

  • Aubin G, Stip E, Gelinas I, Rainville C, Chapparo C. Daily functioning and information-processing skills among persons with schizophrenia. Psychiatr Serv. 2009 Jun;60(6):817-22. doi: 10.1176/ps.2009.60.6.817.

    PubMed 19487353

  • Aubin G, Chapparo C, Gelinas I, Stip E, Rainville C. Use of the Perceive, Recall, Plan and Perform System of Task Analysis for persons with schizophrenia: a preliminary study. Aust Occup Ther J. 2009 Jun;56(3):189-99. doi: 10.1111/j.1440-1630.2007.00725.x.

    PubMed 20854512

  • Lindstad MO, Obstfelder AU, Sveen U, Stigen L. Effectiveness of the Perceive, Recall, Plan and Perform intervention for persons with brain injury in community-based rehabilitation: protocol for a single-case experimental design with multiple baselines. BMJ Open. 2022 Oct 5;12(10):e060206. doi: 10.1136/bmjopen-2021-060206.

    PubMed 36198473

  • Rocamora-Montenegro M, Compan-Gabucio LM, Garcia de la Hera M. Occupational therapy interventions for adults with severe mental illness: a scoping review. BMJ Open. 2021 Oct 29;11(10):e047467. doi: 10.1136/bmjopen-2020-047467.

    PubMed 34716157

  • Allott K, van-der-El K, Bryce S, Parrish EM, McGurk SR, Hetrick S, Bowie CR, Kidd S, Hamilton M, Killackey E, Velligan D. Compensatory Interventions for Cognitive Impairments in Psychosis: A Systematic Review and Meta-Analysis. Schizophr Bull. 2020 Jul 8;46(4):869-883. doi: 10.1093/schbul/sbz134.

    PubMed 32052837

  • Vita A, Barlati S, Ceraso A, Nibbio G, Ariu C, Deste G, Wykes T. Effectiveness, Core Elements, and Moderators of Response of Cognitive Remediation for Schizophrenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Psychiatry. 2021 Aug 1;78(8):848-858. doi: 10.1001/jamapsychiatry.2021.0620.

    PubMed 33877289

Questions about this trial

What is this clinical trial studying?

A study testing Perceive, Recall, Plan and Perform intervention Interventions: in people with Schizophrenia, run by Sykehuset Innlandet HF.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Elisabeth Haug, PhD (0047 95781487, elisabeth.haug@sykehuset-innlandet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PRPP assessment (time frame: Assesments just after the intervention, as well as at 3 and 6 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 NCT06790186, which also lists 8 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 23 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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