Depression Clinical Trial
Official title:
Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
NCT number | NCT05406414 |
Other study ID # | ADA_1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2022 |
Est. completion date | December 31, 2023 |
Verified date | May 2022 |
Source | University of Aarhus |
Contact | Mette Kragh, PhD |
Phone | 9117 1262 |
mekrag[@]rm.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | December 31, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder - Insomnia Severity Index (ISI) = 14 (exceeding the threshold for a sleep problem) - Sleep problems for 3 months: 3 times a week at least one of the following: - Sleep onset latency = 30 minutes - Wake after sleep onset = 30 minutes - Total sleep time = 11 hours per day - Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M. - Irregular circadian rhythm; bedtime varies = 3 hours throughout the week Exclusion Criteria: - Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk) - Active substance abuse (F10-19) - The sleep problem can be significantly explained by insufficient treatment of physical - disease affecting sleep (documented in patients electronic journal) - Unstable social situation (does not have a permanent residence) - Shift work (= 2 times a week for the last 2 months) - Pregnancy and breast-feeding |
Country | Name | City | State |
---|---|---|---|
Denmark | Mette Kragh | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the severity of the sleep problem | Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | |
Primary | Change in sleep quality. | Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties. | Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint). | |
Secondary | Change in well-being | Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being on a scale ranging from 0 to 100, the higher the score the more well-being. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint | |
Secondary | Level of personal recovery | Measured by the questionnaire INSPIRE-O. A questionnaire which measures personal recovery on a scale ranging from 5 to 25, the higher the score the more recovery. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). | |
Secondary | Change in readiness to take on a job | Measured by the questionnaire, The Work Ability Index. A score of 0 shows the lowest possibility that the person would take on a job, the score 10 is the highest possibility | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | |
Secondary | Changes in health-related items. | The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | |
Secondary | Change in consumption of sleep medications | Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period. | Is registered daily during the 6 week study period | |
Secondary | Changes in sleep efficiency | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period. | |
Secondary | Changes in sleep latency | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period | |
Secondary | Changes in sleep nocturnal awakenings | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period. |
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