Project Meaningful Activities and Recovery
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Occupational therapy interventions are often part of the treatment and rehabilitation
      services offered to people with mental illnesses. Occupational therapy can be an important
      contribution when the purpose is to promote participation in everyday activities that are
      meaningful for the individual. (1-3) There is limited evidence to support whether
      occupational therapy interventions for people with mental illnesses have an effect. (2,3)
      Based on principles from Lifestyle Redesign®, which is an evidence-based occupational therapy
      intervention for older people, a comparative qualitative study with participant experiences
      from various psychosocial rehabilitation efforts, and a dialogue-based collaboration with
      experienced occupational therapists and peer staff from community mental health centers, we
      developed a new recovery oriented occupational therapy intervention to people with
      disabilities due to mental illness.

      The intervention "Meaningful activities and recovery" (MA&R) - is an eight-month
      rehabilitation program. The aim of MA&R is to enable participation in activities that are
      meaningful to the individual.

      Project Meaningful Activities and Recovery (MA&R) is a clinical trial where the purpose is to
      compare the effects of: 1) "Meaningful activities and Recovery" (MA&R) in addition to
      standard care and 2) standard care as it is now offered to people with psychiatric
      disabilities.

      The design is a randomized clinical trial with self-reported assessments. Based on sample
      size calculation, 128 participants will be included in the trials. The primary endpoint is
      activity engagement, and the secondary effect goals are personal recovery, functioning and
      quality of life. Participants are followed up at the end of the intervention, after eight
      months.
    

Detailed description: 
      Participants Participants are people, diagnosed with mental illness and who uses services in
      either community mental health centres in Copenhagen, or live in supported accommodations, or
      receive psychiatric rehabilitation services in Copenhagen, Odense or Svendborg, three Danish
      cities.

      Recruitment The initial contact with the participants is done by staff at the community
      mental health centres, supported housings or rehabilitation services in Copenhagen, Odense
      and Svendborg, talking with relevant candidates based on the research project's inclusion and
      exclusion criteria and informing them orally and in writing about the research project. This
      is supplemented, with the approval of the sites, by hanging posters in common rooms and
      possibly. presentation by researcher to the resident group / patients / citizen group at
      joint meeting to encourage self-referral. People who are interested in participating in the
      research project (hereinafter referred to as potential participants) contact the researcher
      or notify this to staff who communicate contact with researcher on behalf of citizens. An
      appointment is made for information interviews and pre-screening. Potential participants are
      invited to bring relatives or a contact person to the appointment. The oral information is
      given before the written one, and it is ensured that the information conversation takes place
      undisturbed. The participant information is provided in the form of a folder with adequate
      information about the experiment. The potential participant is informed that participation in
      the trial is voluntary and should not have any side effects, and that at any time they may
      exit the trial, without consequence for future support and the right to psychiatric treatment
      or rehabilitation services.

      If the prospective participant, after being informed of the research project, is still
      interested in participating in the research project, the researcher conducts a functional
      level assessment at Mini-ICF-APP and asks the potential participant whether he or she is
      diagnosed with a mental illness. Based on this, it is decided whether the potential
      participant can be included.

      Then, a consent form is handed out. Three-day reflection time (at least 24 hours) is offered.
      The written consent will be dated and numbered with the participant number. The participant
      will receive a copy while the original will be archived in a locked cabinet and scanned
      electronically and stored on a logged drive.

      When written consent is given, the researcher obtains data by asking the participant, ie.
      self-reporting socio-demographic data and information on the mental illness. The researcher
      sends questionnaires to the participant, either electronically or as a letter, depending on
      what the participant prefers.

      All participants receive a serial number and data are entered in REDCap.

      Randomization and blinding Participants who have given informed consent and who have
      completed the questionnaires (baseline data) are randomized to either the control group or
      the intervention group. Randomization is done in RedCap. It is randomized according to
      varying block sizes, unknown to the researcher. The researcher makes sure to inform the
      participant which group they have come in either directly or through referring staff.

      The researcher, staff and participants are not blinded to which group the participant comes
      in. To ensure blindness in collecting follow-up data, these data are obtained by research
      assistants who are blinded on the allocation. Blinding of the researcher during the analysis
      phase and when drawing conclusions is ensured by the participants being provided with a new
      serial number before the analyzes begin and the intervention groups are indicated by a "x"
      and "y".

      Interventions There are two types of interventions

        1. MA&R in addition to standard services

        2. Standard services

      MA&R lasts eight months and consists of two courses, MA&R I and MA&R II, which are
      contemplated by each other. MA&R I supports a greater self-awareness of the importance of
      daily life activities and is primarily based on reflection and conversation. MA&R II is about
      anchoring new activities, habits or patterns of action in everyday life and is primarily
      action-oriented.

      MA&R I consists of six group sessions and five individual meetings. The community sessions
      take place weekly and typically lasts two hours, with the possibility of shortening the
      meeting for one hour.

      The MA&R II consists of five joint sessions and six dialogue meetings. As in MA&R I, the
      joint sessions and dialogue meetings take place alternately. For the joint sessions, the
      participants are presented with strategies and tools for enabling activity participation, for
      example, by promoting a energy and / or overview in everyday life, trying out ways to analyze
      and solve problems, or make gradual changes in everyday life by setting sub-goals.

      Standard services in community mental health centres include appointments with psychiatrist,
      psychologists and/or care manager, psychoeducation, social skills training and relational
      support. Standard services within the rehabilitation services in Odense, Svendborg and
      Copenhagen include drop-in centres, self-esteems groups, peer-services, skills-training and
      relational support.

      Data collection Baseline data is obtained by interview and questionnaires. The questionnaires
      are sent electronically by email or by mail. The questionnaires are returned to the
      researcher before randomization. In the event of failure to answer one or more items, these
      are reviewed by calling the participant in order to clarify any. question and get the answer
      complete. Healthcare services and the participants' diagnosis are obtained via the National
      Patient Register. Information about death is obtained from the Cause of Death Register.
      Meeting in MA&R will be registered by MA&R mentors, and will be returned to researcher after
      eight months of follow-up. At eight months of follow-up, the researcher sends questionnaires
      to the participants electronically or by letter, depending on what the participant prefers.
      Where the participants do not answer the questionnaires on their own, the participant will
      receive a reminder of this, by mail and / or telephone inquiry. The participant will be
      offered assistance from research to fill out the questionnaires. Data will be stored in
      REDCap. Declarations of consent will be scanned and stored on logged drives.

      Fidelity Fidelity will be monitored once per course with MA&R Fidelity Scale, an instrument
      developed for the purpose. The evaluation will be done by external evaluators.

      Sample size and power calculations

      Sample size calculations is based on tracking a minimal but clinically significant difference
      between the intervention group and the POES-S control group (increased engagement in
      meaningful activities). Eklund et al. found in their RCT a small effect of 1.4 points
      measured on POES-S (d = 0.27) by "Balancing Everyday Life. (39) Since MA&R is of a more
      comprehensive format (in terms of duration and costs) than BEL, the clinically significant
      difference to be tracked is set to 3 points. When the standard deviation is 5.9 (39), power
      is 80% and the significance level is 5%, a total of 128 participants, 64 in each group must
      be included to track this difference.

      Power calculation on the secondary outcomes is based on the fact that there are 64
      participants in respectively the intervention and control group. Since it has not been
      possible to identify studies with the same intervention and target group as this study, the
      estimated effect size is based on expert opinions, systematic reviews and what is considered
      to be a clinically significant difference for the target group of the intervention
      (corresponding to a moderate effect size on d = 0.5.)

      Statistics All outcome variables are continuous. The primary outcome is activity engagement,
      measured on POES-S. This variable will be analyzed as a continuous variable. Differences
      between the intervention group and the control group will be analyzed using ANOVA to
      determine statistical significance. Clinical significance will be calculated at Cohens d.

      Multiple multivariate imputations will be used and all covariates with putative prognostic
      significance will be used to impute a distribution of missing data.

      The continuous effect measurements will be analyzed with "repeated measurement model in mixed
      model analyzes with unstructured variance". The prerequisite for using this analysis and for
      the use of multiple imputation is that data is missing at random or data missing completely
      at random as opposed to non-ignorable non-response. This distinction is important because
      repeated measurement and multiple imputation are both models based on a statistical
      estimation of non-existent responses, and the preconditions for this estimation must be met
      in order for the assays to be valid.

      We will analyze whether the conditions for using repeated measurement and multiple imputation
      are present by conducting a drop-out analysis. Significant prognostic characteristics of the
      non-followers will be compared to the participants remaining in the trial. Variables where
      there is a difference between participants and non-participants will be included as
      co-variates in the analyzes. Data analysis will be based on the intention-to-treat principle.
      Data from all participants will be included corresponding to the group to which they have
      been allocated. As a supplementary analysis, we will make per-protocol where complete cases
      will be analyzed.

      At detailed plan for analysis will be uploaded at ClinicalTrials.gov prior analysis
    

Intervention name(s): Meaningful Activities and Recovery; Standard Care and Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MA&R is a new rehabilitation program for people with psychiatric disabilities. MA&R aims to enable participation in everyday activities that are meaningful to the individual.
MA&R is based on occupational science, and the underlying premise that there is a connection between mental health, recovery and meaningful everyday activities. The goal of MA&R is that participants through the course become better at connecting daily activities with values, interests, plans and goals. When this connection is strengthened, it supports the experience of meaningfulness in everyday life.
MA&R is led by two mentors where one mentor is an occupational therapist (or similar) and the other has lived experiences of mental vulnerability and recovery.; For community mental health centres: medicine, psychoeducation, relational support, peer-support, psychotherapy, social counselling, care manager
For psychiatric rehabilitation services in Copenhagen, Odense and Svendborg: drop in centres, relational support, skills training, peer-support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychiatric Disabilities; Rehabilitation; Recovery; Occupational therapy; Peer-support