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

NCT04695132 | Unknown

• 1 other identifier: 20211805
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Investigating the effects of the treatment on the chosen outcome measures.
2. 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. 3.Investigating the experiences of staff working with the intervention, through the lense of Normalization Process Theory.

Conditions

Psychotic Disorders; Forensic Psychology; Forensic Nursing; Antisocial Personality Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (2)

• Health of Nation Outcome Scale-Secure version (HoNOS-S) (change from baseline levels to post treatment, estimated approximately 9 months after baseline).

  An informant rating scale answered by the participants treating psychiatrists. The scale provides information on informant assessment of the participants level of symptom burden, functioning and the perceived need of special security measures in the care of the patient. The scale consists of a total of 19 items, 12 pertaining to clinical factors regarding perceived symptom burden and level of functioning and 7 pertaining to the perceived necessity of security arrangements associated with the care of the individual participant/patient.

  This comparison will be made between HoNOS ratings in treatment and control group taken before treatment commencement and directly following treatment completion (estimated 9 months in between)

• World Health Organizations Disability Assessment Schedule 2.0 36-item version, interview administered. (change from baseline levels to post treatment estimated 9 months after baseline).

  An interviewed schedule designed to measure the respondents health and level of disability. Measures this in six subdomains (cognition, mobility, personal care, relations, daily activities and participation). Research participants are interviewed with this assessment schedule.

  This comparison will be made between WHODAS ratings in treatment and control group taken before treatment commencement and directly following treatment completion (estimated 9 months in between)

Secondary Outcomes (13)

• Illness Management and Recovery Scale-Self report version (change from baseline to measure taken 4 months after treatment start)

  Control and active group´s change scores between baseline measure and 4-months after treatment commencement will be compared.

• Illness Management and Recovery Scale-Self report version (change from baseline to post-treatment completion, estimated 9 months in between).

  Control and active group´s change scores between baseline measure and treatment completion (estimated to 9 months in between) will be compared.

• Illness Management and Recovery Scale-Self report version (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).

  Control and active group´s change scores between baseline measure and follow up 3 months after treatment completion (estimated time 12-months between the measures) will be compared.

• Illness Management and Recovery Scale- Clinician administered version (change from baseline to follow up 4 months after treatment start)

  Control and active group´s change scores between baseline measure and 4-months after treatment commencement will be compared.

• Illness Management and Recovery Scale- Clinician administered version (change from baseline to post-treatment completion, estimated 9 months in between).

  Control and active group´s change scores between baseline measure and treatment completion (estimated to 9 months in between) will be compared.

Other Outcomes (6)

• Normalization Process Theory Measure Swedish version (S-NoMAD) (12 months after treatment start)

  This measurement takes place 12 months after treatment commencement.

• Normalization Process Theory Measure Swedish version (S-NoMAD) (before treatment start)

  This measure is answered by staff administrating treatment, after of preparatory training approximately 2 weeks before treatment commencement.

• Normalization Process Theory Measure Swedish version (S-NoMAD) (3-months after treatment start).

  This measurement takes place 3 months after treatment commencement.

Study Arms (2)

Illness Management and Recovery treatment programme (intervention group)

EXPERIMENTAL

These patients receive the Illness Management and Recovery treatment. Treatment takes place during 2 Group sessions and 1 individual session per week.

Behavioral: Illness Management and Recovery treatment programme

Treatment as usual (control group)

NO INTERVENTION

These patients receive treatment as usual consisting of the standard treatment given at the respective inpatient forensic mental health facility where they are admitted.

Interventions

Illness Management and Recovery treatment programme BEHAVIORAL

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.

Illness Management and Recovery treatment programme (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient of court mandated forensic mental health care following conviction of crime and diagnosis of serious mental illness
• Deemed capable of giving informed consent to research by treating medical staff

You may not qualify if:

• Recipient of treatment for other reason than court mandated care (e.g., recipients of prison sentences receiving temporary mental health treatment, patients receiving compulsory mental care without previous conviction of crime)
• Deemed uncapable or unwilling to give informed consent

Sponsors & Collaborators

• Karolinska Institutet: lead
• Dalarna County Council, Sweden: collaborator

Study Sites (1)

Rättspsykiatriska kliniken i Sala

Sala, 73325, Sweden

Location

Related Publications (1)

• Andersson P, Tistad M, Eriksson A, Enebrink P, Sturidsson K. Implementation and evaluation of Illness Management and Recovery (IMR) in mandated forensic psychiatric care - Study protocol for a multicenter cluster randomized trial. Contemp Clin Trials Commun. 2022 Mar 9;27:100907. doi: 10.1016/j.conctc.2022.100907. eCollection 2022 Jun.

  PMID: 35499065 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Antisocial Personality Disorder; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders; Chemically-Induced Disorders

Study Officials

• Knut Sturidsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer/PhD

Model Details: Participants will be assigned to one of two arms: Active treatment arm (recipients of Illness Management and Recovery) and Control condition (TAU). Participants in the Control condition will be offered Illness Management and Recovery after study completion, conditional on them still being treated at the forensic inpatient treatment sites that are part of the study. Participants will be recruited in clusters (consisting of wards at inpatient treatment sites) and enrollment of new clusters will take place continually during data collection.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 5, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)