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Young People and Illness Management and Recovery (IMR)

29 septembre 2022 mis à jour par: Anne-Lise Holmesland, University Hospital, Akershus

Young People's Experiences of Illness Management and Recovery (IMR) - an Explorative Study

The study is a combined clinical patient outcome study and a health-services research sub-study. Illness management and recovery (IMR) constitutes an evidence-based practice with 11 modules focusing on personal recovery developed for adults with severe mental health illnesses. IMR can be offered in groups or individually, once a week for 10-12 months.

Little is known about how young people experience the utility of IMR treatment groups in child and adolescent mental health outpatient clinics. The primary aim is to explore in-depth how the participants experience the utility of the IMR approach. The health research sub-study will provide new insights into the IMR implementation process in outpatient clinics for adolescents.

Aperçu de l'étude

Description détaillée

IMR has previously been implemented for adolescents in an inpatient unit in the hospital's catchment area. In order to offer the same treatment to all young patients, IMR treatment groups will be established in 4 out of 7 outpatient clinics in the hospital's catchment area. Participants belonging to the clinics in which no IMR treatment groups are being established will be invited to participate in IMR groups in clinics nearby.

The primary aim is to gain new insight into how young people experience the utility of IMR treatment groups conducted in outpatient practices and, if relevant, which changes could be made to adapt IMR more to young people. To explore how the participants experience the utility of IMR treatment groups, a qualitative focus-group study, consisting of a maximum of 5 focus-group interviews will be conducted. The participants in each IMR treatment group will be offered treatment once a week up to 10-12 months. To establish an IMR treatment group a minimum of 4 patients and a maximum of 8 participants must participate. Participants are mainly being included in the IMR treatment groups at the two primary admissions to each treatment group. Thus, some of the participants in the focus-groups may have participated in IMR groups for less than 10-12 months.

Secondary outcomes are related to fidelity to the model and the extent to which IMR treatment groups are implemented at an organizational level. The treatment groups will be led by trained IMR-therapists employed in inpatient units, together with therapists in training who are employed in outpatient clinics. Leaders and other clinicians in the outpatient clinics will contribute knowledge about the extent to which core components of IMR are being implemented, as well as information relating to quality improvement and individual adjustment. Two of the out-patient clinics in which no IMR group is being established will be included in the sub-study. The clinics will receive written feedback after each measurement time to support quality improvement.

The goal is to include up to 48 participants receiving IMR treatment in outpatient clinics. Up to 8 hospitalized participants will participate in a pilot focus-group interview. In the sub-study, a maximum of 16 IMR therapists, trained and in training, and up to 24 staff members will be invited to participate.

Type d'étude

Observationnel

Inscription (Réel)

10

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Viken, Norvège
        • Akershus Universitetssykehus

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients between 13-17 years of age suffering from or having symptoms of psychosis or bipolar disorders, and who participate in an IMR treatment group at one of the 4 (out of 7) outpatient clinics in the hospitals catchment area, and who are able to give informed consent. Up to 8 inpatients or previous inpatients between 13- 17 years of age suffering from various diagnoses will be invited to participate in a pilot focus-group interview. Trained clinicians and clinicians in training contribute to the implementation in the outpatient clinics together with clinic leaders and other clinicians.

La description

Inclusion Criteria Patients:

Outpatient units:

  • Included in the IMR group in one of the outpatient clinics
  • Able to give informed consent

Inpatient unit (focus group):

  • 13-17 years of age
  • Current or previous patient
  • Able to understand and speak Norwegian
  • Able to give informed consent

Exclusion criteria (inpatient unit)

  • Younger than 13 years
  • Mental retardation
  • Manic phase

Inclusion Criteria: IMR therapists:

  • IMR therapist leading IMR treatment groups in one of the participating outpatient clinics
  • Trained or training in IMR
  • Employed at the Department for Child and Adolescent Mental Health Services at Akershus University Hospital.

Inclusion Criteria: Other staff members

• Employed at the Department for Child and Adolescent Mental Health Services at Akershus University Hospital.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
IMR patients
Patients from outpatient clinics receiving IMR from trained IMR therapists and IMR therapists in training.
Treatment given in groups, weekly for 10-12 months.
Autres noms:
  • RMI
IMR therapists and other staff
Clinic leaders, IMR therapists and other staff participating in semi-structured individual or group interviews.
Semi-structured individual or group interviews conducted three times with staff on each participating outpatient clinic.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Focus-group interview aiming to explore the significance of the participant's own understanding of and knowledge about the disorder.
Délai: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
End of treatment group, on average 11 months.
Focus-group interview aiming to explore the impact of the IMR treatment on dealing with everyday life.
Délai: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
End of treatment group, on average 11 months.
Focus-group interview aiming to explore the importance of meeting other young people in the same situation.
Délai: End of treatment group, on average 11 months.
Focus-group interviews when the treatment group has come to an end aimed at exploring different perspectives on IMR treatment.
End of treatment group, on average 11 months.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The Illness Management and Recovery Scale (IMRS)
Délai: Baseline (0 months), 6 and 12 months.
A 15-item scale that assesses illness self-management on a 5-point Likert scale where 5 indicates full self-management and 0 indicates no self-management. The scale measures consumer behavior relating to core components in the IMR program. The scale includes parallel clinician and consumer versions. Participants participating in IMR groups for less than 10-12 months will attend fewer measuring times.
Baseline (0 months), 6 and 12 months.
The Illness Management Fidelity Scale
Délai: Baseline (0 months), 6 and 12 months.
Assesses the degree of fidelity with 13 items on a 5-point Likert scale where 5 indicates full implementation and 0 indicates no implementation. Filled in by researchers on the basis of a semistructured interview with staff members.
Baseline (0 months), 6 and 12 months.
General Organizational Index
Délai: Baseline (0 months), 6 and 12 months.
A 12-item scale measuring organizational outcome of implementation, on a 5-point Likert scale where 5 indicates full implementation and 0 indicates no implementation. The scale is filled in by researchers on the basis of a semi-structured interview with staff members.
Baseline (0 months), 6 and 12 months.
Attendance registration
Délai: Baseline (0 months), 3, 6, 9 and 12 months.
The number of sessions the patients are attending in the IMR treatment group.
Baseline (0 months), 3, 6, 9 and 12 months.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Mapping the total number of patients identified receiving a psychosis-related diagnosis within the categories F 20-39 (ICD 10) for the years 2021-2023.
Délai: End of treatment group, on average of 11 months.
The numbers will be displayed in the form of statistics obtained in the hospital. The numbers will be compared to what has been reported in the annual reports for the clinics from 2015 to 2020.
End of treatment group, on average of 11 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Anne-Lise Holmesland, PhD, University Hospital, Akershus

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 mars 2021

Achèvement primaire (Réel)

30 juin 2022

Achèvement de l'étude (Réel)

30 juin 2022

Dates d'inscription aux études

Première soumission

14 février 2021

Première soumission répondant aux critères de contrôle qualité

26 février 2021

Première publication (Réel)

2 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2022

Dernière vérification

1 septembre 2022

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 20/09657

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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