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

NCT03654248 | Completed

• 1 other identifier: ORU 2018/191
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 8

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.

Conditions

Neurodevelopmental Disorders; Mental Disorder

Keywords

Time management; Group intervention; Executive function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• 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

  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

  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

  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

  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

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

Study Arms (2)

Let's Get Organized group intervention

EXPERIMENTAL

Group intervention with 10 weekly sessions, each lasting 1,5 hours

Behavioral: Let's Get Organized group intervention

Individual Occupational Therapy

ACTIVE COMPARATOR

Individual intervention lasting 10 weeks

Device: Individual Occupational Therapy

Interventions

Let's Get Organized group intervention BEHAVIORAL

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.

Also known as: LGO

Let's Get Organized group intervention

Individual Occupational Therapy DEVICE

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.

Individual Occupational Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• intellectual disability

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Region Örebro County: collaborator
• Dalarna County Council, Sweden: collaborator
• Uppsala University: collaborator
• Region Gävleborg: collaborator
• State University of New York - Downstate Medical Center: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (8)

Öppenvårdspsykiatrisk mottagning

Falun, Dalarna County, 79131, Sweden

Location

Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm

Stockholm, Sweden

Location

Neuropsykiatriska mottagningen, Akademiska sjukhuset

Uppsala, Sweden

Location

Hallsberg psykiatrisk öppenvård

Hallsberg, Örebro County, 69436, Sweden

Location

Karlskoga psykiatrisk öppenvård

Karlskoga, Örebro County, 69181, Sweden

Location

Lindesberg psykiatrisk öppenvård

Lindesberg, Örebro County, 71182, Sweden

Location

USÖ psykiatrisk öppenvård och affektiva enhet

Örebro, Örebro County, 70116, Sweden

Location

Vuxenhabiliteringen - Autismteamet

Örebro, Örebro County, 70116, Sweden

Location

Related 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.

  PMID: 34538253 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Marie Holmefur, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 31, 2018
• Study Start: November 9, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 18, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (8)