Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major Depression (NCT02678702) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major Depression
Denmark47 participantsStarted 2015-08
Plain-language summary
Participants (N=47) are patients with major depression. Participants are assessed with clinical interview, polysomnographic evaluation and screening with Insomnia Severity Index (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HDRS, MINI and Sleep Diary pre and post treatment.
Participants are randomly assigned to either treatment as usual or CBT-I. The latter receives individual as well as group therapy with CBT-I during 6 sessions.
Post-treatment: The investigators will compare changes in sleep diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test, Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.
Who can participate
Age range
18 Years – 67 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Unipolar depression, either as a single episode or as periodic depression.
* HAM-D17 \> 18, i.e. moderate to severe depression.
* Time spent on falling asleep: more than 30 minutes at least three nights a week or
* Interrupted sleep with wake periods lasting more than 30 minutes at least three nights a week.
* Symptoms must have lasted for at least a month.
Exclusion Criteria:
* Other sleep disorder (e.g. moderat to severe Sleep apnoea and Periodic Limb Movements)
* Physical disorder that affects sleep to a considerable degree.
* Schizophrenia and bipolar disorder.
* Subject to other ongoing psychological treatment besides standard treatment.
* Suicidal to the equivalent of level 3 on HAM-D 17.
* Active substance abuse problem.
* Pregnancy.
* Shift work.
* Do not speak or understand danish
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.