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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders; Mental Disorder
• Intervention / Treatment: Behavioral: Let's Get Organized group intervention; Device: Individual Occupational Therapy

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm
  • Uppsala, Sweden
    • Neuropsykiatriska mottagningen, Akademiska sjukhuset
  • Örebro, Sweden, 70116
    • USÖ psykiatrisk öppenvård och affektiva enhet
  • Örebro, Sweden, 70116
    • Vuxenhabiliteringen - Autismteamet
  • Dalarna
    • Falun, Dalarna, Sweden, 79131
      • Öppenvårdspsykiatrisk mottagning
  • Orebro
    • Karlskoga, Orebro, Sweden, 69181
      • Karlskoga psykiatrisk öppenvård
  • Örebro
    • Hallsberg, Örebro, Sweden, 69436
      • Hallsberg psykiatrisk öppenvård
    • Lindesberg, Örebro, Sweden, 71182
      • Lindesberg psykiatrisk öppenvård

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Let's Get Organized group intervention; Group intervention with 10 weekly sessions, each lasting 1,5 hours	Behavioral: Let's Get Organized group intervention; 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.; Other Names: LGO
Active Comparator: Individual Occupational Therapy; Individual intervention lasting 10 weeks	Device: Individual Occupational Therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Uppsala University; State University of New York - Downstate Medical Center; Dalarna County Council, Sweden; Region Örebro County; Uppsala County Council, Sweden; Region Gävleborg
• Investigators: Principal Investigator: Marie Holmefur, PhD, Örebro University, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Group intervention; Executive function; Time management
• Additional Relevant MeSH Terms: Pathologic Processes; Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: ORU 2018/191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No