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

Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654248
• Other study ID #: ORU 2018/191
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2023
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorder
• Mental Disorders
• Neurodevelopmental Disorders

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	Öppenvårdspsykiatrisk mottagning	Falun	Dalarna
Sweden	Hallsberg psykiatrisk öppenvård	Hallsberg	Örebro
Sweden	Karlskoga psykiatrisk öppenvård	Karlskoga	Orebro
Sweden	Lindesberg psykiatrisk öppenvård	Lindesberg	Örebro
Sweden	USÖ psykiatrisk öppenvård och affektiva enhet	Örebro
Sweden	Vuxenhabiliteringen - Autismteamet	Örebro
Sweden	Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm	Stockholm
Sweden	Neuropsykiatriska mottagningen, Akademiska sjukhuset	Uppsala

Sponsors (7)

Lead Sponsor	Collaborator
Örebro University, Sweden	Dalarna County Council, Sweden, Region Gävleborg, Region Örebro County, State University of New York - Downstate Medical Center, Uppsala County Council, Sweden, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Autism Quotient Short	28 items, 28-112 points	baseline (pre-intervention), 10 weeks, 24 weeks
Secondary	Adult Attention Deficit Hyperactivity disorder Self-report Scale	18 items, score 1-90	baseline (pre-intervention), 10 weeks, 24 weeks