InsomniaNCT02678702
Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major Depression
A study testing CBT-I and Treatment as usual in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Insomnia
- What is being tested?
- CBT-I and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy.
- Shift work.
- Do not speak or understand danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Insomnia in Patients With Major Depression Disorder Using Cognitive Behavioral Therapy, Sleep Restriction and Stimulus Control Therapy. A Randomized, Controlled 8 Week Study
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.
Read the detailed description
Participants are included from an Outpatient clinic and GPs in Aarhus. Initial assessment is carried out through a personal interview with the participants who are screened with Hamilton Depression Rating Scale, MINI (Mini International Neuropsychiatric Interview) and instructed to fill out an ISI-form (Insomnia Severity Index (Morin, 1993)), DBAS-16, Dysfunctional Beliefs and Attitudes about Sleep Scale, (Morin, 1993) and to keep a sleep diary for two weeks.
All participants go through an objective examination of their sleep through a polysomnography measuring brain activity (EEG), eye activity (EOG), muscular activity (EMG), heart rate, respiration a.o. during sleep. This happens on an outpatient basis with assistance of an experienced sleep technician. Data is analysed by an experienced sleep physician.
After assessment participants are randomized receiving either treatment as usual or CBT-I.
CBT-I includes: Sleep Restriction Therapy, Stimulus Control Therapy, Relaxation Training, Identification and analyzation of negative thoughts and cognitive distortion, Modification of negative thoughts about sleep, Reattribution, Implementation of "Scheduled worry", Relapse prevention.
Post-treatment participants undergo polysomnographic evaluation and screening with HDRS, ISI and DBAS. Again they keep a sleep diary.
Categorical variables are analysed with a chi-square test. Ordinal variables are analysed with non-parametrical tests (Wilcoxon-Mann-Whitney U-test) and variance analysis (ANOVA). Possible confounders as differences in demographics or other treatment, which may affect the target outcome, will be analysed in part with non-parametrical tests and in part in a logistic regression analysis. As secondary effect targets total sleep time and changes in polysomnography as well as changes in HDRS, dysfunctional assumptions on sleep and life quality are measured. STATA is used for data processing with SPSS as a possible alternative solution.
- Conditions
- Insomnia
- Being tested
- CBT-I, Treatment as usual
- Keywords
- Sleep, Depression, Comorbid Insomnia, Cognitive Behavioral Therapy, Sleep Restriction, Stimulus Control therapy, Relaxation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
CBT-I
Treatment as usualBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Behavioral intervention: CBT-I Receives: Behavioral: CBT-I; Behavioral: Treatment as usual |
| Treatment as usual | Active comparator | Intervention: Control group receiving treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Total sleep time (minutes).
Obtained through sleep diary
Measured: 8 weeks
Secondary outcomes (1)
Score on HamD17 (points)
Obtained through semistructured interview
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Erik Roj Larsen, PhD, Study chair, Psychiatry in the Region of Southern Denmark, Odense, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678702
- Sponsor's protocol ID
- 109566
- Status last verified
- Nov 2016
- First submitted
- 23 Oct 2015
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Dyrberg H, Bjorvatn B, Larsen ER. Cognitive Behavioral Therapy for Chronic Insomnia in Outpatients with Major Depression-A Randomised Controlled Trial. J Clin Med. 2022 Oct 1;11(19):5845. doi: 10.3390/jcm11195845.
PubMed 36233712
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Insomnia in Patients With Major Depression Disorder Using Cognitive Behavioral Therapy, Sleep Restriction and Stimulus Control Therapy. A Randomized, Controlled 8 Week Study
- ClinicalTrials.gov ID
- NCT02678702
- Acronym / sponsor ID
- 109566
- Conditions
- Insomnia
- Keywords
- Sleep, Depression, Comorbid Insomnia, Cognitive Behavioral Therapy, Sleep Restriction, Stimulus Control therapy, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants are included from an Outpatient clinic and GPs in Aarhus. Initial assessment is carried out through a personal interview with the participants who are screened with Hamilton Depression Rating Scale, MINI (Mini International Neuropsychiatric Interview) and instructed to fill out an ISI-form (Insomnia Severity Index (Morin, 1993)), DBAS-16, Dysfunctional Beliefs and Attitudes about Sleep Scale, (Morin, 1993) and to keep a sleep diary for two weeks.
All participants go through an objective examination of their sleep through a polysomnography measuring brain activity (EEG), eye activity (EOG), muscular activity (EMG), heart rate, respiration a.o. during sleep. This happens on an outpatient basis with assistance of an experienced sleep technician. Data is analysed by an experienced sleep physician.
After assessment participants are randomized receiving either treatment as usual or CBT-I.
CBT-I includes: Sleep Restriction Therapy, Stimulus Control Therapy, Relaxation Training, Identification and analyzation of negative thoughts and cognitive distortion, Modification of negative thoughts about sleep, Reattribution, Implementation of "Scheduled worry", Relapse prevention.
Post-treatment participants undergo polysomnographic evaluation and screening with HDRS, ISI and DBAS. Again they keep a sleep diary.
Categorical variables are analysed with a chi-square test. Ordinal variables are analysed with non-parametrical tests (Wilcoxon-Mann-Whitney U-test) and variance analysis (ANOVA). Possible confounders as differences in demographics or other treatment, which may affect the target outcome, will be analysed in part with non-parametrical tests and in part in a logistic regression analysis. As secondary effect targets total sleep time and changes in polysomnography as well as changes in HDRS, dysfunctional assumptions on sleep and life quality are measured. STATA is used for data processing with SPSS as a possible alternative solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: CBT-I, Behavioral: Treatment as usualBehavioral intervention: CBT-I |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualIntervention: Control group receiving treatment as usual |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-ICBT-I | Behavioural | CBT-I |
| Treatment as usualTreatment as usual | Behavioural | CBT-I, Treatment as usual |
Primary outcome
Patients Total sleep time (minutes).
Time frame: 8 weeks
Obtained through sleep diary
1 secondary outcome
Score on HamD17 (points)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 36233712Dyrberg H, Bjorvatn B, Larsen ER. Cognitive Behavioral Therapy for Chronic Insomnia in Outpatients with Major Depression-A Randomised Controlled Trial. J Clin Med. 2022 Oct 1;11(19):5845. doi: 10.3390/jcm11195845.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Roj Larsen, PhD study chair
Psychiatry in the Region of Southern Denmark, Odense, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and Treatment as usual in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Total sleep time (minutes). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.