NCT03869177

Brief Summary

This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in community mental health centres, by using a cluster randomised design. Fifteen Norwegian outpatient units participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster. Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and relatives, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, relatives and health care personnel. The study will also include a cost-effectiveness analysis and a political economy analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

February 28, 2019

Last Update Submit

January 3, 2023

Conditions

Psychotic Disorders

Keywords

Family psychoeducationSchizophreniaImplementation scienceMental health care servicesClinical ethicsFamily involvementFamily intervention

Outcome Measures

Primary Outcomes (5)

  • Implementation study: Fidelity to the intervention model - Family psychoeducation 1

    Change in score on fidelity scale for performance and content of family psychoeducation. Rated from 1 (low) to 5 (high).

    Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  • Implementation study: Fidelity to the intervention model - Family psychoeducation 2

    Change in score on fidelity scale for penetration rate and general organisation of family psychoeducation. Rated from 1 (low) to 5 (high).

    Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  • Implementation study: Fidelity to the intervention model - Family involvement and support 1

    Change in total fidelity measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).

    Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  • Implementation study: Fidelity to the intervention model - Family involvement and support 2

    Change in penetration rate, measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).

    Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

  • Implementation study: Fidelity to the intervention model - Family involvement and support 3

    Change in content, structure and implementation, measured by the scale for family involvement and support. Rated from 1 (low) to 5 (high).

    Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.

Secondary Outcomes (20)

  • Patient quantitative sub-study: Patient experiences of their own mental health and functioning.

    0, 6 and 12 months.

  • Patient quantitative sub-study and economic sub-study: Quality of life

    0, 6 and 12 months.

  • Patient quantitative sub-study: General satisfaction.

    0, 6 and 12 months.

  • Patient quantitative sub-study: Experienced burden of mental health problems.

    0, 6 and 12 months.

  • Patient quantitative sub-study: Perceived warmth and criticism from relative.

    0, 6 and 12 months.

  • +15 more secondary outcomes

Other Outcomes (6)

  • Patient quantitative sub-study: Alcohol abuse

    0 months - baseline screening only

  • Patient quantitative sub-study: Drug abuse

    0 months - baseline screening only

  • Patient quantitative sub-study and implementation study: Exposure to family psychoeducation.

    Baseline screening, then 6 and 12 months

  • +3 more other outcomes

Study Arms (2)

Intervention arm

OTHER

Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period.

Other: Implementation support program

Control arm

NO INTERVENTION

Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period.

Interventions

Implementation support programOTHER

The IFIP intervention consists of the following elements: I. Clinical interventions 1.1 A basic level of family involvement and support 1.2 Family psychoeducation in single-family groups II. Implementation interventions 2.1 Training and guidance of health care personnel 2.2 A family coordinator 2.3 Other implementation measures

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have an established psychotic disorder (F20-29 in ICD-10) or a tentative diagnosis of psychotic disorder, certain enough to begin treatment. This need not be the patient's primary diagnosis.

You may not qualify if:

  • To be sentenced to psychiatric treatment.
  • Not being competent to consent to participation in research.
  • Having completed more than five joint sessions of family psychoeducation in single-family groups (patient and relative together) or more than ten joint sessions (multiple families together) in multiple-family groups, or a similarly structured family intervention.
  • Not having any relatives or next of kin.
  • Being a relative of a patient with a diagnosis as described above.
  • Having completed more than five joint sessions (patient and relative together) of family psychoeducation in single-family groups or more than ten joint sessions (multiple families together) in multiple-family groups, or a similarly structured family intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Asker DPS - Vestre Viken HF

Asker, Norway

Location

Drammen DPS - Vestre Viken HF

Drammen, Norway

Location

Ringerike DPS - Vestre Viken HF

Hønefoss, Norway

Location

Kongsberg DPS - Vestre Viken HF

Kongsberg, Norway

Location

DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark

Kragerø, Norway

Location

Vestfold DPS - Sykehuset i Vestfold HF

Larvik, Norway

Location

Nedre Romerike DPS - Akershus Universitetssykehus HF

Lillestrøm, Norway

Location

Groruddalen DPS - Akershus Universitetssykehus HF

Oslo, Norway

Location

Søndre Oslo DPS - Oslo Universitetssykehus HF

Oslo, Norway

Location

Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus

Oslo, Norway

Location

DPS poliklinikk Porsgrunn - Sykehuset Telemark

Porsgrunn, Norway

Location

Bærum DPS -Vestre Viken HF

Sandvika, Norway

Location

DPS poliklinikk Seljord - Sykehuset Telemark

Seljord, Norway

Location

DPS poliklinikk Skien - Sykehuset Telemark

Skien, Norway

Location

Vestfold DPS - Sykehuset i Vestfold HF

Tønsberg, Norway

Location

Related Publications (28)

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    BACKGROUND

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  • Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22-31. doi: 10.1159/000081413.

    PMID: 15608468BACKGROUND

  • Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

    PMID: 8329970BACKGROUND

  • Karterud S, Pedersen G, Løvdal H, Friis S. S-GAF: Global Funsjonsskåring - Splittet Versjon [Global Assessment of Functioning - Split version]. Bakgrunn og skåringsveiledning. Klinikk for psykiatri, Ullevål sykehus, Oslo, 1998.

    BACKGROUND

  • Hooley JM, Teasdale JD. Predictors of relapse in unipolar depressives: expressed emotion, marital distress, and perceived criticism. J Abnorm Psychol. 1989 Aug;98(3):229-35. doi: 10.1037//0021-843x.98.3.229.

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  • Pharoah F, Mari J, Rathbone J, Wong W. Family intervention for schizophrenia. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD000088. doi: 10.1002/14651858.CD000088.pub2.

    PMID: 21154340BACKGROUND

  • Yesufu-Udechuku A, Harrison B, Mayo-Wilson E, Young N, Woodhams P, Shiers D, Kuipers E, Kendall T. Interventions to improve the experience of caring for people with severe mental illness: systematic review and meta-analysis. Br J Psychiatry. 2015 Apr;206(4):268-74. doi: 10.1192/bjp.bp.114.147561.

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  • Helsedirektoratet. (2013). Utredning, behandling og oppfølging av personer med psykoselidelser. Retrieved March 22, 2018, from https://helsedirektoratet.no/Lists/Publikasjoner/Attachments/326/Nasjonal-faglig-retningslinje-for-utredning-behandling-og-oppfolging-av-personer-med-psykoselidelser-IS-1957.pdf.

    BACKGROUND

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    BACKGROUND

  • McHugo GJ, Drake RE, Whitley R, Bond GR, Campbell K, Rapp CA, Goldman HH, Lutz WJ, Finnerty MT. Fidelity outcomes in the National Implementing Evidence-Based Practices Project. Psychiatr Serv. 2007 Oct;58(10):1279-84. doi: 10.1176/ps.2007.58.10.1279.

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  • Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

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  • Norheim I, Pedersen R, Selle ML, Rossberg JI, Hestmark L, Heiervang KS, Ruud T, Asholt VM, Hansson KM, Moller P, Fosse R, Kjus SHH, Romoren M. Effectiveness of implementing family involvement on patient outcomes in individuals with psychotic disorders: a pragmatic cluster randomised controlled trial. BMC Psychiatry. 2025 Dec 4;25(1):1142. doi: 10.1186/s12888-025-07501-z.

    PMID: 41345598DERIVED

  • Norheim I, Pedersen R, Selle ML, Rossberg JI, Hestmark L, Heiervang KS, Ruud T, Asholt VM, Hansson KM, Moller P, Fosse R, Romoren M. Implementation of guidelines on Family Involvement for persons with Psychotic disorders: a pragmatic cluster randomized trial. Effect on relatives' outcomes and family interventions received. Front Psychiatry. 2024 May 24;15:1381007. doi: 10.3389/fpsyt.2024.1381007. eCollection 2024.

    PMID: 38855639DERIVED

  • Hestmark L, Romoren M, Heiervang KS, Hansson KM, Ruud T, Saltyte Benth J, Norheim I, Weimand B, Pedersen R. Implementation of Guidelines on Family Involvement for Persons with Psychotic Disorders (IFIP): A Cluster Randomised Controlled Trial. Adm Policy Ment Health. 2023 May;50(3):520-533. doi: 10.1007/s10488-023-01255-0. Epub 2023 Feb 16.

    PMID: 36797515DERIVED

  • Hansson KM, Romoren M, Weimand B, Heiervang KS, Hestmark L, Landeweer EGM, Pedersen R. The duty of confidentiality during family involvement: ethical challenges and possible solutions in the treatment of persons with psychotic disorders. BMC Psychiatry. 2022 Dec 20;22(1):812. doi: 10.1186/s12888-022-04461-6.

    PMID: 36539741DERIVED

  • Hansson KM, Romoren M, Pedersen R, Weimand B, Hestmark L, Norheim I, Ruud T, Hymer IS, Heiervang KS. Barriers and facilitators when implementing family involvement for persons with psychotic disorders in community mental health centres - a nested qualitative study. BMC Health Serv Res. 2022 Sep 12;22(1):1153. doi: 10.1186/s12913-022-08489-y.

    PMID: 36096844DERIVED

  • Hestmark L, Heiervang KS, Pedersen R, Hansson KM, Ruud T, Romoren M. Family involvement practices for persons with psychotic disorders in community mental health centres - a cross-sectional fidelity-based study. BMC Psychiatry. 2021 Jun 2;21(1):285. doi: 10.1186/s12888-021-03300-4.

    PMID: 34078306DERIVED

  • Hestmark L, Romoren M, Heiervang KS, Weimand B, Ruud T, Norvoll R, Hansson KM, Norheim I, Aas E, Landeweer EGM, Pedersen R. Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial. BMC Health Serv Res. 2020 Oct 9;20(1):934. doi: 10.1186/s12913-020-05792-4.

    PMID: 33036605DERIVED

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Reidar Pedersen, PhD

    Professor and head of department, Centre for medical ethics,University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Patients and relatives will not be informed about their outpatient clinic's allocation status. However, they may deduce this from the kind of treatment they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study is a cluster randomised controlled trial. Fourteen clusters will be stratified into three strata according to their estimated number of patients with psychotic disorders currently in treatment. The clusters within each stratum will then be randomised to either intervention or control arms with an allocation ratio of 1:1.The seven outpatient units in the intervention arm receives a comprehensive implementation support program, whereas the outpatient clinics in the control arm receives no implementation support. A similar number of patients and relatives will be recruited from both arms, preferably in dyadic pairs, for the quantitative patient- and relative sub study. Employees from the clusters in the intervention arm will be recruited to answer a questionnaire, as part of the implementation study. Patients, relatives and employees will be recruited from the clusters in the intervention arm to take part in qualitative interviews.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 11, 2019

Study Start

March 21, 2019

Primary Completion

November 30, 2021

Study Completion

May 30, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(15)