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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02077829
Other study ID # IMR 01/2014
Secondary ID 2013/2035b
Status Completed
Phase N/A
First received February 25, 2014
Last updated January 11, 2016
Start date March 2014
Est. completion date June 2015

Study information

Verified date January 2016
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the barriers and facilitators of implementing Illness Management and Recovery (IMR) in Norwegian mental health services.


Description:

IMR is an evidence-based practice developed for people with severe mental illnesses. It is based on the principles of recovery to help people set individual meaningful goals for their lives and gain illness self-management skills and thereby contribute to their individual recovery-process. IMR can be given individually or in groups, once a week for 10-12 months.

In this project the investigators will implement Illness Management and Recovery (IMR) in mental health services. The implementation strategy are carried out according to the IMR toolkits which include informational and training materials, implementation recommendations, and fidelity scales to facilitate use of the model in routine practices. The implementation process and outcome will be of main focus.

The study has an observational prospective cohort design. 30 therapists from 9 different mental health services will be trained and supervised in IMR. The investigators aim to enrol 40 patients. The primary outcome is therapists' fidelity to the model and organisational implementation outcome. Secondary outcomes are patients' level of functioning and hope.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria Therapists:

- Voluntary recruited therapists in the participating mental health services

- trained and consulted in IMR

Inclusion Criteria Patients:

- Adults (18+)

- Associated with one of the participating mental health services

- symptoms on or diagnosis of severe mental illness with or without drug abuse

- giving informed consent verbally and in writing

Exclusion Criteria Patients:

- Patients with acute risk of suicidal behaviour

- not able to communicate in Norwegian

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Behavioral:
Illness Management and Recovery
Evidence-based practice given individually or in groups, weekly for 10-12 months.

Locations

Country Name City State
Norway Ahus R&D Mental Health Services Lørenskog

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Akershus Helse Sor-Ost, Romeriksprosjektet

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Illness Management Fidelity Scale (SAMHSA, 2009) Assesses the degree of fidelity with 13 items on a 5-point likert scale where 5 indicates full implementation and 0 indicates no implementation 12 months No
Secondary The Illness Management & Recovery Treatment Integrity Scale (IT-IS) (McGuire et al., 2012 A 16-item scale measuring clinicians' faithful replication of the model 12 months No
Secondary The Adult State Hope Scale (Snyder et al., 1996) A 6-item self-report scale of patients' hope and optimism 12 months No
Secondary The Illness Management and Recovery Scale (SAMHSA, 2009) Assessing patients' recovery outcomes in the IMR program with 15 items. About 11 months after start of intervention No
Secondary General Organizational Index (SAMHSA, 2009) A 12-item scale measuring organisational outcome of implementation by common agency practices that support evidence-based practices 12 months No
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