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Completed

NCT Number: NCT03654248

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Öppenvårdspsykiatrisk mottagning, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LGO

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.

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

    Time frame: baseline (pre-intervention), 10 weeks, 24 weeks

    11 items, reported as 0-100 ATMS units

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2018
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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