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

NCT ID: NCT03654248

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2022-08-31

Brief Summary

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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

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Conditions

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Neurodevelopmental Disorders Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Let's Get Organized group intervention

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

Group Type EXPERIMENTAL

Let's Get Organized group intervention

Intervention Type 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.

Individual Occupational Therapy

Individual intervention lasting 10 weeks

Group Type ACTIVE_COMPARATOR

Individual Occupational Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Other Intervention Names

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LGO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role collaborator

Dalarna County Council, Sweden

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Region Gävleborg

OTHER

Sponsor Role collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Holmefur, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Öppenvårdspsykiatrisk mottagning

Falun, Dalarna County, Sweden

Site Status

Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm

Stockholm, , Sweden

Site Status

Neuropsykiatriska mottagningen, Akademiska sjukhuset

Uppsala, , Sweden

Site Status

Hallsberg psykiatrisk öppenvård

Hallsberg, Örebro County, Sweden

Site Status

Karlskoga psykiatrisk öppenvård

Karlskoga, Örebro County, Sweden

Site Status

Lindesberg psykiatrisk öppenvård

Lindesberg, Örebro County, Sweden

Site Status

USÖ psykiatrisk öppenvård och affektiva enhet

Örebro, Örebro County, Sweden

Site Status

Vuxenhabiliteringen - Autismteamet

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 34538253 (View on PubMed)

Other Identifiers

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ORU 2018/191

Identifier Type: -

Identifier Source: org_study_id

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