Illness Management and Recovery- a Cluster Randomized Controlled Trial Within a Forensic Mental Inpatient Setting

NCT04695132 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-05

No results posted yet for this study

Summary

The purpose of the study is to investigate the effects of a psychoeducational intervention program, Illness Management and Recovery (henceforth abbreviated as IMR), when administered to inpatient forensic mental health patients. IMR is a treatment program that can be administered in both a group and an individual format. It is designed for persons suffering from severe mental health problems and has two principal aims: 1. promoting participants´ capacity to manage and alleviate symptoms and functional impairment and 2. helping participants in formulating and attaining subjectively meaningful recovery goals. Forensic mental health inpatients receiving this treatment will be compared to patients who receive treatment as usual on a variety of outcome measures, such as clinician and self-rated levels of symptoms, function and perceived levels of hope. Furthermore, clinicians' experiences of working with the intervention will be investigated using a structured questionnaire regarding implementation processes and through an interview protocol.

The study has 3 objectives:

1. Investigating the effects of the treatment on the chosen outcome measures.
2. Investigating the effects of potential moderators on treatment outcome. These moderators include: pre-treatment functional status measured by self and informant report, neuropsychological performance and pre-admission indicators of presence of criminogenic risk factors and everyday functioning.
3. Investigating the experiences of staff working with the intervention, through the lense of Normalization Process Theory.

Conditions

Interventions

BEHAVIORAL

Illness Management and Recovery treatment programme

The Illness Management and Recovery treatment programme is a psychosocial treatment aimed at attaining illness management skills and promoting a sense of personal recovery amongst patients with serious mental illness. The original treatment protocol has been translated to Swedish and adapted to a forensic mental health setting. The treatment consists of ten chapters containing information and practical exercises relating to topics relevant for mental health and mental health recovery. These topics include medication use, stress reduction, problem solving, recovery goals and navigating the forensic mental health system. Participants are assigned practical homework and tasks to be completed outside of treatment sessions. Group sessions are conducted to present and discuss treatment material. Individual sessions are used to rehearse treatment content, personalize the treatment and review progress in achieving tasks agreed upon in the group setting.

Sponsors & Collaborators

Principal Investigators

  • Knut Sturidsson, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695132 on ClinicalTrials.gov