NCT04778085

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

February 14, 2021

Last Update Submit

September 29, 2022

Conditions

Keywords

Psychosis

Outcome Measures

Primary Outcomes (3)

  • Focus-group interview aiming to explore the significance of the participant's own understanding of and knowledge about the disorder.

    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.

    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.

    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.

Secondary Outcomes (4)

  • The Illness Management and Recovery Scale (IMRS)

    Baseline (0 months), 6 and 12 months.

  • The Illness Management Fidelity Scale

    Baseline (0 months), 6 and 12 months.

  • General Organizational Index

    Baseline (0 months), 6 and 12 months.

  • Attendance registration

    Baseline (0 months), 3, 6, 9 and 12 months.

Other Outcomes (1)

  • 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.

    End of treatment group, on average of 11 months.

Study Arms (2)

IMR patients

Patients from outpatient clinics receiving IMR from trained IMR therapists and IMR therapists in training.

Behavioral: Illness management and recovery

IMR therapists and other staff

Clinic leaders, IMR therapists and other staff participating in semi-structured individual or group interviews.

Other: Semi-structured interviews

Interventions

Treatment given in groups, weekly for 10-12 months.

Also known as: IMR
IMR patients

Semi-structured individual or group interviews conducted three times with staff on each participating outpatient clinic.

IMR therapists and other staff

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Outpatient units:
  • Included in the IMR group in one of the outpatient clinics
  • Able to give informed consent
  • Inpatient unit (focus group):
  • years of age
  • Current or previous patient
  • Able to understand and speak Norwegian
  • Able to give informed consent

You may not qualify if:

  • Younger than 13 years
  • Mental retardation
  • Manic phase
  • 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.
  • Employed at the Department for Child and Adolescent Mental Health Services at Akershus University Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus universitetssykehus

Viken, Norway

Location

MeSH Terms

Conditions

Psychotic DisordersBipolar Disorder

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Anne-Lise Holmesland, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinsipal investigator

Study Record Dates

First Submitted

February 14, 2021

First Posted

March 2, 2021

Study Start

March 9, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations