Let's Get Organized Feasibility Study

Mental Disorder Clinical Trial

Official title:

Pilot Study of "Let's Get Organized" - a Group Intervention for Improving Time Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659279
• Other study ID #: ORU 2015/015
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to pilot test the Let's Get Organized (LGO) Occupational Therapy intervention in a Swedish context by exploring possible enhancements in time management skills, aspects of executive functioning, and satisfaction with daily occupations in persons with time-management difficulties due to neurodevelopmental and/or mental disorders.

Method:

A pre-post design with 3 and 12-months follow-up is used.

The LGO intervention is a manual-based group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopmental disorders. The LGO is conducted as 10 weekly 1.5-hour group sessions. Two trained group leaders, lead each group of 6-8 participants. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. All group sessions follow the same format, and each session has a set theme. Group sessions are structured with a slide presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.

The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills (ATMS-S). Secondary outcomes are executive functioning measured with the Weekly Calendar Planning Activity (WCPA) and satisfaction with daily occupations, which is measured with the interview-administered questionnaire Satisfaction with Daily Occupations 13 items (SDO-13).

Data will be collected before intervention start (pre intervention), after intervention completion (post intervention) and 3 and 12 months post intervention completion. The ATMS will be collected at all four time points. The WCPA and SDO-13 will be collected pre, post and 12 months post intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• 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 neurodevelopmental 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
• Psychotic Disorders

Intervention

Behavioral:
• Let's Get Organized
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 a PowerPoint presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Assessment of Time Management Skills (ATMS-S) Time management sub scale	Time management (11 items) measured in ATMS units (range 0-100)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Secondary	Change in Weekly Calendar Planning Activity (WCPA-SE) No of appointments	No of correctly entered appointments (range 0-17) Total time No of strategies used No of rules followed (0-5)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Weekly Calendar Planning Activity (WCPA-SE) Total time	Total time No of strategies used No of rules followed (0-5)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Weekly Calendar Planning Activity (WCPA-SE) Strategies	No of strategies used No of rules followed (0-5)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Weekly Calendar Planning Activity (WCPA-SE) Rules followed	No of rules followed (range 0-5)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Satisfaction with Daily Occupations 13 items (SDO-13) Activity sub scale	No of activities (range 0-13)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Satisfaction with Daily Occupations 13 items (SDO-13) Satisfaction sub scale	Satisfaction sub scale score (each item is scored 1-7 and summed to a sub scale score, range 13-91, higher score indicates better satisfaction)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Satisfaction with Daily Occupations 13 items (SDO-13) Global satisfaction sub scale	Global satisfaction score (range 1-5, lower score indicates better satisfaction)	baseline (pre-intervention), 10 weeks, 62-months
Secondary	Change in Assessment of Time Management Skills (ATMS-S) Organization and planning sub scale	Organization and Planning (11 items) measured in ATMS units (range 0-100)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months
Secondary	Change in Assessment of Time Management Skills (ATMS-S) Regulation of emotions sub scale	Regulation of emotions (5 items) measured in ATMS units (range 0-100)	baseline (pre-intervention), 10 weeks, 24 weeks, 62-months