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

• ClinicalTrials.gov Identifier: NCT03654248
• Recruitment Status: Recruiting
• First Posted: August 31, 2018
• Last Update Posted: May 6, 2021
• Sponsor: Örebro University, Sweden
• Collaborators: Region Örebro County; Dalarna County Council, Sweden; Uppsala University; Region Gävleborg; State University of New York - Downstate Medical Center; Uppsala County Council, Sweden
• Information provided by (Responsible Party): Örebro University, Sweden

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neurodevelopmental Disorders; Mental Disorder	Behavioral: Let's Get Organized group intervention; Device: Individual Occupational Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults With Cognitive Limitations
• Actual Study Start Date: August 27, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: June 2022

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   11 items, reported as 0-100 ATMS units

Secondary Outcome Measures :

1. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Performance test of executive functioning. No of correctly entered appointments (range 0-17)
2. Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Performance test of executive functioning. Total time
3. Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Performance test of executive functioning. No of strategies used more strategies are better
4. Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Performance test of executive functioning. No of rules followed (range 0-5) More rules followed are better
5. Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Performance test of executive functioning. Efficacy score (high score is better)
6. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   No of activities (range 0-17, higher scores are better)
7. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Satisfaction score (range 13-91, higher scores are better)
8. Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Global satisfaction score (range 1-5, lower scores are better)
9. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
   Occupational balance (nominal data)
10. Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    Self-efficacy (range 0-40, higher score is better)
11. Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention start [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    Sense of competence (range 15-90, higher score is better)
12. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    Individual item scores on 5 items scored 1-5
13. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    One visual-analogue-scale answer (range 0-100)
14. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    11 items, reported as 0-100 ATMS units
15. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    5 items, reported as 0-100 ATMS units
16. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
17. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    1 item, reported as 0-4 points
18. Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
19. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    3 items, reported as 0-12 points
20. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
21. Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    1 items, reported as 0-4 points
22. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
23. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    1 items, reported as 0-4 points
24. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    1 items, reported as 0-4 points
25. 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 [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
26. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    1 items, reported as 0-4 points
27. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    2 items, reported as 0-8 points
28. Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domain [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    3 items, reported as 0-12 points
29. Autism Quotient Short [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    28 items, 28-112 points
30. Adult Attention Deficit Hyperactivity disorder Self-report Scale [ Time Frame: baseline (pre-intervention), 10 weeks, 24 weeks ]
    18 items, score 1-90

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Kajsa Lidström-Holmqvist, PhD; +46703531520; kajsa.lidstrom-holmqvist@regionorebrolan.se

Locations

Sweden

Öppenvårdspsykiatrisk mottagning; Recruiting

Falun, Dalarna, Sweden, 79131

Contact: Occupational Therapist

Karlskoga psykiatrisk öppenvård; Recruiting

Karlskoga, Orebro, Sweden, 69181

Contact: Occupational Therapist

Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm; Recruiting

Stockholm, Sweden

Neuropsykiatriska mottagningen, Akademiska sjukhuset; Not yet recruiting

Uppsala, Sweden

NP Resurs och samverkan; Recruiting

Örebro, Sweden, 70116

Contact: Occupational Therapist

Socialpsykiatrin i Örebro kommun; Withdrawn

Örebro, Sweden, 70116

USÖ psykiatrisk öppenvård och affektiva enhet; Recruiting

Örebro, Sweden, 70116

Contact: Occupational Therapist

Vuxenhabiliteringen - Autismteamet; Recruiting

Örebro, Sweden, 70116

Contact: Occupational Therapist

Hallsberg psykiatrisk öppenvård; Recruiting

Hallsberg, Örebro, Sweden, 69436

Contact: Occupational Therapist

Lindesberg psykiatrisk öppenvård; Recruiting

Lindesberg, Örebro, Sweden, 71182

Contact: Occupational Therapist

Sponsors and Collaborators

Örebro University, Sweden

Region Örebro County

Dalarna County Council, Sweden

Uppsala University

Region Gävleborg

State University of New York - Downstate Medical Center

Uppsala County Council, Sweden

Investigators

• Principal Investigator: Marie Holmefur, PhD; Örebro University, Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Holmefur M, Roshanay A, White S, Janeslätt G, Vimefall E, Lidström-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.

• Responsible Party: Örebro University, Sweden
• ClinicalTrials.gov Identifier: NCT03654248
• Other Study ID Numbers: ORU 2018/191
• First Posted: August 31, 2018
• Last Update Posted: May 6, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Örebro University, Sweden:

Time management; Group intervention; Executive function

Additional relevant MeSH terms:

Disease; Mental Disorders; Neurodevelopmental Disorders; Pathologic Processes