Let's Get Organized in Adult Psychiatric/Habilitation Care

Study Overview
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Brief Summary
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This project aims to evaluate and establish evidence for a novel, group-based intervention that can help people with cognitive limitations due to mental or neurodevelopmental disorders to improve their ability to manage time and organize activities. This might provide an important step towards establishing healthy life habits, getting or maintaining employment, and managing family life. Time management is a necessary skill for maintaining healthy life habits and daily occupations in modern society. People with limited cognitive function due to, for example, mental or neurodevelopmental disorders, have documented difficulties in time management, which is also related to issues with self-efficacy. Common interventions for persons with poor time management are time-assistive devices and products, but studies show that these devices alone are not enough to cover these people's needs. Structured training is needed, but there is a lack of structured interventions to enhance time management skills. The intervention program Let's get organized (LGO) is a manual-based group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopmental disorders. In a recent feasibility study the LGO showed promising results. This project aims to evaluate to what extent the LGO intervention is effective in improving time management, and satisfaction with daily occupations. The proposed project is a randomized-controlled trial carried out in ten psychiatric units in Sweden. Participants (n=104) will be randomly assigned to either LGO group intervention or individual Occupational Therapy intervention for ten weeks .The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills. Secondary outcomes are occupational balance, self-efficacy, parental competence and cost-effectiveness.

Official Title
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Randomized Controlled Trial of Let's Get Organized; an Intervention Program for Improving Time Management Skills in Adults With Cognitive Limitations

Conditions
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Neurodevelopmental Disorders, Mental Disorder

Intervention / Treatment
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* Behavioral: Let's Get Organized group intervention
* Device: Individual Occupational Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopment disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively Exclusion Criteria: intellectual disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Let's Get Organized group intervention<br>Group intervention with 10 weekly sessions, each lasting 1,5 hours | Behavioral: Let's Get Organized group intervention<br>* Group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopment disorders. Each group has 6-8 participants and is lead by two trained group leaders. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. Group sessions are structured with PowerPoint presentation and a course manual, an information from the group leaders is intermixed with discussion among the participants and tasks to complete.<br>* Other names: LGO;|
| Active Comparator: Individual Occupational Therapy<br>Individual intervention lasting 10 weeks | Device: Individual Occupational Therapy<br>* Individual meetings with Occupational Therapist (standard therapy) during a 10-week period. Number of meetings and exact nature of intervention depends on the client's needs and is decided by the treating occupational therapist. Interventions will include prescription or instruction regarding time assistive devices and instructions regarding structure and planning of everyday life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Assessment of Time Management Skills-Swedish, Time management sub scale at 10 weeks after intervention start and at 24 weeks after intervention start | 11 items, reported as 0-100 ATMS units | baseline (pre-intervention), 10 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weekly Calendar Planning Activity-Swedish version No of correct appointments at 10 weeks after intervention start and at 24 weeks after intervention start | Performance test of executive functioning. No of correctly entered appointments (range 0-17) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention start | Performance test of executive functioning. Total time | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention start | Performance test of executive functioning. No of strategies used more strategies are better | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention start | Performance test of executive functioning. No of rules followed (range 0-5) More rules followed are better | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention start | Performance test of executive functioning. Efficacy score (high score is better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Satisfaction with daily occupations and occupational balance (SDO-OB) activity score at 10 weeks after intervention start and at 24 weeks after intervention start | No of activities (range 0-17, higher scores are better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Satisfaction with daily occupations and occupational balance (SDO-OB) satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start | Satisfaction score (range 13-91, higher scores are better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start | Global satisfaction score (range 1-5, lower scores are better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Satisfaction with daily occupations and occupational balance (SDO-OB) occupational balance at 10 weeks after intervention start and at 24 weeks after intervention start | Occupational balance (nominal data) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention start | Self-efficacy (range 0-40, higher score is better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention start | Sense of competence (range 15-90, higher score is better) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L) item scores at 10 weeks after intervention start and at 24 weeks after intervention start | Individual item scores on 5 items scored 1-5 | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in EuroQuality of Life - 5 dimensions - 5 levels (EQ-5D-5L) global score at 10 weeks after intervention start and at 24 weeks after intervention start | One visual-analogue-scale answer (range 0-100) | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Assessment of Time Management Skills-Swedish (ATMS-S), Organization and planning sub scale at 10 weeks after intervention start and at 24 weeks after intervention start | 11 items, reported as 0-100 ATMS units | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Assessment of Time Management Skills-Swedish (ATMS-S), Regulation of emotions sub scale at 10 weeks after intervention start and at 24 weeks after intervention start | 5 items, reported as 0-100 ATMS units | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domain | 1 item, reported as 0-4 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domain | 3 items, reported as 0-12 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain | 1 items, reported as 0-4 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domain | 1 items, reported as 0-4 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domain | 1 items, reported as 0-4 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: repetitive thoughts and behaviors domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domain | 1 items, reported as 0-4 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domain | 2 items, reported as 0-8 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domain | 3 items, reported as 0-12 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Autism Quotient Short | 28 items, 28-112 points | baseline (pre-intervention), 10 weeks, 24 weeks | 
| Adult Attention Deficit Hyperactivity disorder Self-report Scale | 18 items, score 1-90 | baseline (pre-intervention), 10 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time management, Group intervention, Executive function