Clinical trial NCT04695132: Illness Management and Recovery- a Cluster Randomized Controlled Trial Within a Forensic Mental Inpatient Setting
Official title: Illness Management and Recovery- en behandlingsutvärdering Inom rättspsykiatrin.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Forensic Psychology
Forensic Nursing
Antisocial Personality Disorder
Substance Use Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Dalarna County Council, Sweden
First posted: 2021-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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.

Detailed description: The plan is to conduct the study through a cluster-randomized approach. Recruitment will take place amongst inpatients in the Swedish forensic mental health services. The clusters of patients randomized to the two study conditions will in effect be inpatient forensic mental health wards at Swedish forensic facilities. Enrolment and randomizing of clusters will take place stepwise during the duration of the study. Inpatient wards at participating sites will be randomized to either the control or the active condition and patients at these wards will be asked to give informed consent before participating in the study. After training, the staff at these wards will administer IMR to patients during two group sessions and one individual session a week. The IMR treatment administered consist of 10 chapters containing information and exercises pertaining to subjects relevant to mental health and recovery, such as medication use, social support, problem solving, etc. Translation of the original IMR-manual into Swedish and adaptions to the forensic mental health setting was done with permission from the original developers and authors of the treatment protocol. Study participants at control wards will receive treatment as usual. Data collection takes place at four times during the study (before start of treatment, four months into treatment, post treatment and during a three month follow-up). During data collection, participants fill in self-report measurements of symptom levels, functional impairment and perceived hope. Clinicians with good knowledge of participants also complete informant questionnaires on perceived levels of patient symptoms and functioning. During the data collection that takes place before treatment, participants also complete a neuropsychological test ("Zoo park" from the Behavioral assessment of dysexecutive syndrome, BADS). Anamnestic data pertaining to the pre-admission functioning and criminal history of the patients in the active condition will also be collected from the patient files. The data collection mentioned in the previous two sentences will be done to investigate potential moderators of treatment outcomes.

The outcome measures used in the study are WHODAS 2.0 (World Health Organization Disability Schedule 2.0 self-report and informant versions), IMRs (Illness management and Recovery treatment scale, self-report and informant versions), HoNOS-S (Health of Nation Outcome Scale-Secure version) and ASHS (Adult State Hope Scale). During the data collection four months into treatment, only IMRs and ASHS is completed, whereas all outcome scales are completed during the other data collection points. During the data collection post-treatment, treatment participants also complete CSQ-8 (Client Satisfaction Questionnaire-8).

The experiences of the staff administrating the treatment also will be investigated, with the purpose of exploring the process of implementing the intervention in this setting. This will be done using the Swedish version of the NoMAD-questionnaire (Normalization Process Theory Measure), which is a tool developed to operationalize the theoretical framework of Normalization Process Theory. The staff will complete this questionnaire after receiving training in the intervention, three months after treatment commencement and during a follow-up a year after treatment commencement. During the latter two of these data collection points staff will also be interviewed in a semi-structured fashion, using the questions in the NoMAD-questionnaire as a starting point for collection of more in depth qualitative data on the implementation of IMR. The part of the study pertaining to staff experiences of working with IMR are exploratory in character and we do not consider NoMAD to be a measure of treatment outcome.

As mentioned above, certain anamnestic data and neuropsychological performance (measured by the Zoo-map subtest), will be collected and analyzed as potential moderators of treatment outcome. The pre-treatment self and informant-report of everyday functioning (measured by WHODAS 2.0) will also be analyzed as a potential moderator of treatment effects on the other outcome measures. Of special interest in this regard will be discrepancies between the participants´ self reported functional status (assessed by WHODAS 2.0 self report) and other measures of functional status (informant version of WHODAS 2.0, performance on the Zoo map-test and anamnestic indicators of functioning). This interest is motivated by previous research indicating that overestimation of own abilities play a part in predicting outcomes for schizophrenia spectrum patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health of Nation Outcome Scale-Secure version (HoNOS-S) (change from baseline levels to post treatment, estimated approximately 9 months after baseline).
timeFrame: 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)
measure: 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).
timeFrame: 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:
measure: Illness Management and Recovery Scale-Self report version (change from baseline to measure taken 4 months after treatment start)
timeFrame: Control and active group´s change scores between baseline measure and 4-months after treatment commencement will be compared.
measure: Illness Management and Recovery Scale-Self report version (change from baseline to post-treatment completion, estimated 9 months in between).
timeFrame: Control and active group´s change scores between baseline measure and treatment completion (estimated to 9 months in between) will be compared.
measure: 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).
timeFrame: 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.
measure: Illness Management and Recovery Scale- Clinician administered version (change from baseline to follow up 4 months after treatment start)
timeFrame: Control and active group´s change scores between baseline measure and 4-months after treatment commencement will be compared.
measure: Illness Management and Recovery Scale- Clinician administered version (change from baseline to post-treatment completion, estimated 9 months in between).
timeFrame: Control and active group´s change scores between baseline measure and treatment completion (estimated to 9 months in between) will be compared.
measure: Illness Management and Recovery Scale- Clinician administered version (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).
timeFrame: 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.
measure: World Health Organizations Disability Assessment Schedule 2.0 36-item version, proxy administered, change between baseline and measure taken after treatment completion (estimated 9 months in between the two measures)
timeFrame: Change scores on the proxy version of WHODAS from baseline measure to a measure taken after treatment completion (estimated 9 months in between) will be compared between active and control group.
measure: World Health Organizations Disability Assessment Schedule 2.0 36-item version, proxy administered (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).
timeFrame: This comparison will be made between scores for control and active group on proxy measures of WHODAS at baseline and a 3 months follow up after completion (i.e. approx. 12 months after baseline measure at treatment start)
measure: Adult State Hope Scale (ASHS) (change from baseline to measure taken 4 months after treatment start)
timeFrame: Control and active group´s change scores between baseline measure and 4-months after treatment commencement will be compared.
measure: Adult State Hope Scale (ASHS) (change from baseline to post-treatment completion, estimated 9 months in between).
timeFrame: Control and active group´s change scores between baseline measure and treatment completion (estimated to 9 months in between) will be compared.
measure: Adult State Hope Scale (ASHS) (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).
timeFrame: 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.
measure: World Health Organizations Disability Assessment Schedule 2.0 36-item version, interview administered. (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).
timeFrame: This comparison will be made between WHODAS ratings in treatment and control group taken at baseline and a 3 months follow up after treatment completion (i.e. approx. 12 months after treatment start)
measure: Health of Nation Outcome Scale-Secure version (HoNOS-S) (change from baseline to 3 months follow up after treatment completion, estimated time 12 months in between).
timeFrame: This comparison will be made between HONOS ratings in treatment and control group taken at baseline and a 3 months follow up after treatment completion (i.e. approx. 12 months after treatment start)
Other outcomes:
measure: Normalization Process Theory Measure Swedish version (S-NoMAD) (12 months after treatment start)
timeFrame: This measurement takes place 12 months after treatment commencement.
measure: Normalization Process Theory Measure Swedish version (S-NoMAD) (before treatment start)
timeFrame: This measure is answered by staff administrating treatment, after of preparatory training approximately 2 weeks before treatment commencement.
measure: Normalization Process Theory Measure Swedish version (S-NoMAD) (3-months after treatment start).
timeFrame: This measurement takes place 3 months after treatment commencement.
measure: Illness Management and Recovery Treatment Integrity Scale (IT-IS) ( approx. 3-months after treatment start)
timeFrame: The first audio recording of an IMR session in the active group, is scheduled to take place approximately 3 months after the treatment start.
measure: Illness Management and Recovery Treatment Integrity Scale (IT-IS) (approx. 5-months after treatment start).
timeFrame: The second audio recording of an IMR session in the active group, is scheduled to take place approximately 5 months after the treatment start.
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: This questionnaire is answered by research participants in the active condition after treatment completion (estimated 9-months after treatment start).
Locations:
city: Sala
country: Sweden
facility: Rättspsykiatriska kliniken i Sala
Study officials:
affiliation: Karolinska Institutet
name: Knut Sturidsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.