Evidence map›Paper›PMID 41345598›Full record

Trial reportBMC psychiatry2025

Effectiveness of implementing family involvement on patient outcomes in individuals with psychotic disorders: a pragmatic cluster randomised controlled trial.

Irene Norheim, Reidar Pedersen, Maria Lie Selle, Jan Ivar Røssberg, Lars Hestmark, Kristin Sverdvik Heiervang, Torleif Ruud, Vilde Maria Åsholt, Kristiane Myckland Hansson, Paul Møller and 3 more

Registry-linked trialAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03869177 (Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03869177 nacompletednot on this map

Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.

TypeinterventionalSponsorUniversity of OsloRan2019 to 2022Enrolled460ConditionsPsychotic DisordersArmsImplementation support program
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Irene NorheimDepartment of Mental Health Research and Development, Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Drammen, Norway. irene.norheim@vestreviken.no.
Reidar PedersenCentre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.
Maria Lie SelleHealth Services Research Unit, Akershus University Hospital, Lørenskog, Norway.
Jan Ivar RøssbergSection for Treatment Research, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.
Lars HestmarkCentre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.
Kristin Sverdvik HeiervangDivision of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.
Torleif RuudInstitute of Clinical Medicine, University of Oslo, Oslo, Norway.
Vilde Maria ÅsholtDepartment of Mental Health Research and Development, Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Drammen, Norway.
Kristiane Myckland HanssonCentre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.
Paul MøllerDepartment of Mental Health Research and Development, Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Drammen, Norway.
Roar FosseDepartment of Mental Health Research and Development, Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Drammen, Norway.
Solveig Helene Høymork KjusDepartment of Mental Health Research and Development, Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Drammen, Norway.
Maria RomørenCentre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this sub-study, as part of the Implementation of guidelines on Family Involvement for persons with Psychotic disorders (IFIP) trial, was to examine the effectiveness of family interventions (FIs) implemented through an implementation support program (ISP) on patients' outcomes.

methodsThe IFIP trial is a cluster randomised controlled trial where 15 Community Mental Health Centre units were randomly allocated either to the ISP, which included FIs as clinical interventions, implementation strategies, and implementation interventions, or to treatment as usual (TAU). In the control arm, patients could have access to FIs. Patients with psychotic disorders in both arms were asked to complete questionnaires at inclusion, 6- and 12 months. The primary outcome was patients' difficulties in interpersonal relationships measured with the Relationships subscale of Behaviour and Symptom Identification scale. The secondary outcomes were patients' mental health and functioning, perceived expressed emotions, recovery, and quality of life. Linear mixed-effects models were used to analyse differences in change over time between the two arms.

resultsWe included 231 patients (135 from the intervention units; 96 from the control units). Except for the first 24% of the 6 months questionnaires, the 6- and 12-month data were collected during the COVID-19 pandemic. There were no significant differences in the primary outcome, difficulties in interpersonal relationships at 12 months, between the intervention and control arms (Cohen's d = -0.19, p = 0.2). The secondary outcomes showed less perceived criticism from the relatives (Perceived Criticism sub-score; d = - 0.4, p = 0.01) and reduced difficulties in overall functioning (Health of the Nation Outcome Scale; d = - 0.29, p = 0.01) in the intervention arm compared to the control arm at 12 months.

conclusionThe FIs, implemented through the ISP, did not achieve significant decreases in patients' difficulties with interpersonal relationships. However, this sub-study indicates that FIs in routine mental health practices can nurture a more positive family environment and enhance the patient's process toward improved functioning. The complexity of the study design, and the restrictions due to COVID-19, may have diminished the implementation and effectiveness of the measured FIs for the patients.

trial registrationClinicalTrials.gov Identifier NCT03869177. Registered 2019-02-28.

Indexed as

FamilyFamily TherapyPsychotic DisordersAdultCOVID-19FemaleHumansInterpersonal RelationsMaleMiddle AgedQuality of LifeCluster randomised controlled trialEvidence-based practiceFamily interventionFamily psychoeducationInterpersonal relationshipsMental health servicesPsychosisSchizophrenia

Identifiers

PMID41345598
PMCPMC12676765

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.