Clinical trial NCT03654248: "Let's Get Organized" in Adult Psychiatric/habilitation Care
Official title: Randomized Controlled Trial of "Let's Get Organized"; an Intervention Program for Improving Time Management Skills in Adults with Cognitive Limitations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Mental Disorder
Keywords: Time management
Group intervention
Executive function
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Region Örebro County
name: Dalarna County Council, Sweden
name: Uppsala University
name: Region Gävleborg
name: State University of New York - Downstate Medical Center
name: Uppsala County Council, Sweden
First posted: 2018-08-31
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
Secondary outcomes:
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Weekly Calendar Planning Activity Swedish version total time at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Weekly Calendar Planning Activity Swedish version no of strategies at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Weekly Calendar Planning Activity Swedish version rules followed at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Weekly Calendar Planning Activity Swedish version efficacy score at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Global satisfaction score at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in General Self-Efficacy Scale at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Parental Sense of Competence at 10 weeks after intervention start and at 24 weeks after intervention start
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: depression domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anger domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: mania domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: anxiety domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: somatic symptoms domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in DSM-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: suicidal ideation domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: psychosis domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: sleep problems domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: memory domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: 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
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: dissociation domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: personality functioning domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Change in Diagnostic and Statistical Manual of Mental Disorders Manual-5 Self-rated level 1 Cross-Cutting Symptom Measure Adult: substance use domain
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Autism Quotient Short
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
measure: Adult Attention Deficit Hyperactivity disorder Self-report Scale
timeFrame: baseline (pre-intervention), 10 weeks, 24 weeks
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Öppenvårdspsykiatrisk mottagning
state: Dalarna
city: Karlskoga
country: Sweden
facility: Karlskoga psykiatrisk öppenvård
state: Orebro
city: Stockholm
country: Sweden
facility: Habiliteringscenter Brommaplan vuxna, Habilitering och Hälsa, Region Stockholm
city: Uppsala
country: Sweden
facility: Neuropsykiatriska mottagningen, Akademiska sjukhuset
city: Örebro
country: Sweden
facility: USÖ psykiatrisk öppenvård och affektiva enhet
city: Örebro
country: Sweden
facility: Vuxenhabiliteringen - Autismteamet
city: Hallsberg
country: Sweden
facility: Hallsberg psykiatrisk öppenvård
state: Örebro
city: Lindesberg
country: Sweden
facility: Lindesberg psykiatrisk öppenvård
state: Örebro
Study officials:
affiliation: Örebro University, Sweden
name: Marie Holmefur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.