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"Let's Get Organized" in Adult Psychiatric/habilitation Care

Not Applicable
Completed
Conditions
Neurodevelopmental Disorders
Mental Disorder
Interventions
Behavioral: Let's Get Organized group intervention
Device: Individual Occupational Therapy
Registration Number
NCT03654248
Lead Sponsor
Örebro University, Sweden
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Let's Get Organized group interventionLet's Get Organized group interventionGroup intervention with 10 weekly sessions, each lasting 1,5 hours
Individual Occupational TherapyIndividual Occupational TherapyIndividual intervention lasting 10 weeks
Primary Outcome Measures
NameTimeMethod
Change in Assessment of Time Management Skills-Swedish, Time management sub scale at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

11 items, reported as 0-100 ATMS units

Secondary Outcome Measures
NameTimeMethod
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domainbaseline (pre-intervention), 10 weeks, 24 weeks

1 item, reported as 0-4 points

Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domainbaseline (pre-intervention), 10 weeks, 24 weeks

3 items, reported as 0-12 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domainbaseline (pre-intervention), 10 weeks, 24 weeks

1 items, reported as 0-4 points

Change in Weekly Calendar Planning Activity-Swedish version No of correct appointments at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Performance test of executive functioning. No of correctly entered appointments (range 0-17)

Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Performance test of executive functioning. Total time

Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Performance test of executive functioning. No of strategies used more strategies are better

Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Performance test of executive functioning. No of rules followed (range 0-5) More rules followed are better

Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Performance test of executive functioning. Efficacy score (high score is better)

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

No of activities (range 0-17, higher scores are better)

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

Satisfaction score (range 13-91, higher scores are better)

Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Global satisfaction score (range 1-5, lower scores are better)

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

Occupational balance (nominal data)

Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Self-efficacy (range 0-40, higher score is better)

Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention startbaseline (pre-intervention), 10 weeks, 24 weeks

Sense of competence (range 15-90, higher score is better)

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

Individual item scores on 5 items scored 1-5

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

One visual-analogue-scale answer (range 0-100)

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

11 items, reported as 0-100 ATMS units

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 startbaseline (pre-intervention), 10 weeks, 24 weeks

5 items, reported as 0-100 ATMS units

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domainbaseline (pre-intervention), 10 weeks, 24 weeks

1 items, reported as 0-4 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domainbaseline (pre-intervention), 10 weeks, 24 weeks

1 items, reported as 0-4 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: repetitive thoughts and behaviors domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domainbaseline (pre-intervention), 10 weeks, 24 weeks

1 items, reported as 0-4 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domainbaseline (pre-intervention), 10 weeks, 24 weeks

2 items, reported as 0-8 points

Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domainbaseline (pre-intervention), 10 weeks, 24 weeks

3 items, reported as 0-12 points

Autism Quotient Shortbaseline (pre-intervention), 10 weeks, 24 weeks

28 items, 28-112 points

Adult Attention Deficit Hyperactivity disorder Self-report Scalebaseline (pre-intervention), 10 weeks, 24 weeks

18 items, score 1-90

Trial Locations

Locations (8)

Öppenvårdspsykiatrisk mottagning

🇸🇪

Falun, Dalarna, Sweden

Karlskoga psykiatrisk öppenvård

🇸🇪

Karlskoga, Orebro, Sweden

Vuxenhabiliteringen - Autismteamet

🇸🇪

Örebro, Sweden

Hallsberg psykiatrisk öppenvård

🇸🇪

Hallsberg, Örebro, Sweden

Lindesberg psykiatrisk öppenvård

🇸🇪

Lindesberg, Örebro, Sweden

USÖ psykiatrisk öppenvård och affektiva enhet

🇸🇪

Örebro, Sweden

Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm

🇸🇪

Stockholm, Sweden

Neuropsykiatriska mottagningen, Akademiska sjukhuset

🇸🇪

Uppsala, Sweden

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