"Let's Get Organized" in Adult Psychiatric/Habilitation Care
Primary Purpose
Neurodevelopmental Disorders, Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Let's Get Organized group intervention
Individual Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neurodevelopmental Disorders focused on measuring Time management, Group intervention, Executive function
Eligibility Criteria
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
Sites / Locations
- Öppenvårdspsykiatrisk mottagning
- Karlskoga psykiatrisk öppenvård
- Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm
- Neuropsykiatriska mottagningen, Akademiska sjukhuset
- USÖ psykiatrisk öppenvård och affektiva enhet
- Vuxenhabiliteringen - Autismteamet
- Hallsberg psykiatrisk öppenvård
- Lindesberg psykiatrisk öppenvård
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Let's Get Organized group intervention
Individual Occupational Therapy
Arm Description
Group intervention with 10 weekly sessions, each lasting 1,5 hours
Individual intervention lasting 10 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
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
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
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)
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)
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)
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)
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)
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)
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)
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
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)
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
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
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
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
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain
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 domain
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 domain
2 items, reported as 0-8 points
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain
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: psychosis domain
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 domain
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 domain
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 domain
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 domain
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 domain
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 domain
3 items, reported as 0-12 points
Autism Quotient Short
28 items, 28-112 points
Adult Attention Deficit Hyperactivity disorder Self-report Scale
18 items, score 1-90
Full Information
NCT ID
NCT03654248
First Posted
August 20, 2018
Last Updated
March 1, 2023
Sponsor
Örebro University, Sweden
Collaborators
Region Örebro County, Dalarna County Council, Sweden, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center, Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03654248
Brief Title
"Let's Get Organized" in Adult Psychiatric/Habilitation Care
Official Title
Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults With Cognitive Limitations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
Collaborators
Region Örebro County, Dalarna County Council, Sweden, Uppsala University, Region Gävleborg, State University of New York - Downstate Medical Center, Uppsala County Council, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders, Mental Disorder
Keywords
Time management, Group intervention, Executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Let's Get Organized group intervention
Arm Type
Experimental
Arm Description
Group intervention with 10 weekly sessions, each lasting 1,5 hours
Arm Title
Individual Occupational Therapy
Arm Type
Active Comparator
Arm Description
Individual intervention lasting 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Let's Get Organized group intervention
Other Intervention Name(s)
LGO
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Individual Occupational Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
11 items, reported as 0-100 ATMS units
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
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
Description
Performance test of executive functioning. No of correctly entered appointments (range 0-17)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Performance test of executive functioning. Total time
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Performance test of executive functioning. No of strategies used more strategies are better
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Performance test of executive functioning. No of rules followed (range 0-5) More rules followed are better
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Performance test of executive functioning. Efficacy score (high score is better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
No of activities (range 0-17, higher scores are better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
Satisfaction score (range 13-91, higher scores are better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Global satisfaction score (range 1-5, lower scores are better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
Occupational balance (nominal data)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Self-efficacy (range 0-40, higher score is better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention start
Description
Sense of competence (range 15-90, higher score is better)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
Individual item scores on 5 items scored 1-5
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
One visual-analogue-scale answer (range 0-100)
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
11 items, reported as 0-100 ATMS units
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
5 items, reported as 0-100 ATMS units
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domain
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domain
Description
1 item, reported as 0-4 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domain
Description
3 items, reported as 0-12 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domain
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain
Description
1 items, reported as 0-4 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domain
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domain
Description
1 items, reported as 0-4 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domain
Description
1 items, reported as 0-4 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
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
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domain
Description
1 items, reported as 0-4 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domain
Description
2 items, reported as 0-8 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domain
Description
3 items, reported as 0-12 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Autism Quotient Short
Description
28 items, 28-112 points
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
Title
Adult Attention Deficit Hyperactivity disorder Self-report Scale
Description
18 items, score 1-90
Time Frame
baseline (pre-intervention), 10 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Holmefur, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Öppenvårdspsykiatrisk mottagning
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79131
Country
Sweden
Facility Name
Karlskoga psykiatrisk öppenvård
City
Karlskoga
State/Province
Orebro
ZIP/Postal Code
69181
Country
Sweden
Facility Name
Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm
City
Stockholm
Country
Sweden
Facility Name
Neuropsykiatriska mottagningen, Akademiska sjukhuset
City
Uppsala
Country
Sweden
Facility Name
USÖ psykiatrisk öppenvård och affektiva enhet
City
Örebro
ZIP/Postal Code
70116
Country
Sweden
Facility Name
Vuxenhabiliteringen - Autismteamet
City
Örebro
ZIP/Postal Code
70116
Country
Sweden
Facility Name
Hallsberg psykiatrisk öppenvård
City
Hallsberg
State/Province
Örebro
ZIP/Postal Code
69436
Country
Sweden
Facility Name
Lindesberg psykiatrisk öppenvård
City
Lindesberg
State/Province
Örebro
ZIP/Postal Code
71182
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34538253
Citation
Holmefur M, Roshanay A, White S, Janeslatt G, Vimefall E, Lidstrom-Holmqvist K. Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
Results Reference
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"Let's Get Organized" in Adult Psychiatric/Habilitation Care
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