DepressionSAFEIINCT02679768
Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression After Discharge
A study testing Circadian Reinforcement Therapy and Standard treatment in people with Depression, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
Very little is known of depressed patients' mental state after being discharged from inpatient wards where they are provided with a sheltered environment with stable sleep wake cycle, regular meals, and regular physical and social activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Circadian Reinforcement Therapy and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2016to 22 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression as defined in DSM-5
- Hospitalized at a psychiatric inpatient ward
- Age above 18
Who cannot join
- Bipolar depression
- Suicidal plans or ideations (score of 2 or more on the HAM-D17 scale) item 3 or if investigator is unsure of level og suicidality
- Dementia or other organic brain damage that might influence ability to use the electronical monitoring system (Daybuilder) and the rules of the study
- Psychotic depression at time of inclusion.
- Abuse of alcohol or other drugs that might influence the ability to comply with study rules
- Patients under any form of coercion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAFE II: Can Electronic Self-monitoring With Closed Loop Feedback Focusing on Regulation of the Sleep-wake Cycle Reduce Relapse of Depression After Discharge From a Psychiatric Ward?
Very little is known of depressed patients' mental state after being discharged from inpatient wards where they are provided with a sheltered environment with stable sleep wake cycle, regular meals, and regular physical and social activities. Our previous usability study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into patients' condition in the weeks after discharge. Results showed that patients over a four week period had significant day to day variations in self-rated mood and sleeping schedule and that the patients' sleep patterns were delayed with 45 minutes.
In the actual study, SAFE II, we are investigating whether an intervention with a strong focus on the circadian timing of daytime activities, and sleep, coined Circadian Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse into depression after discharge.
Read the detailed description
SAFE II Background Patients hospitalized with a depression are generally discharged within 4-6 weeks, but remain vulnerable, and not fully recovered at discharge, hence a majority will be referred to outpatient care. Often, however, patients have to wait for about 2 weeks from discharge to first visit in the outpatient clinic. Our clinical experience is that this period from discharge to start of outpatient care is associated with psychological uncertainty and often cause unstable daily routines for sleep, meals, social life, and exercise. This may result in aggravation of the depression with the associated risk of suicidal thoughts and readmission. Our first study "E-monitoring by depression - Safe I," illustrated these issues. Patients registered their state daily in an electronical application, for sleep, mood, and exercise. Among other things the study showed that the patients' sleep patterns were advanced to later in the evening and longer in the morning thus shifting the sleep-wake cycle to later. One possible explanation for this finding is that patients are not recovered from the depression when discharged and therefore are more vulnerable to changes. Another possible factor is that at home the patients do not have the same support to keep daily structure as during hospitalization. This project "Safe discharge - SafeII" is based on the experience from the first study and will investigate whether a focused intervention in the benefits of a stable sleep in the recovery of a depression can help prevent worsening of the depression in the waiting time for outpatient treatment. It is well documented that stable sleep and circadian rhythm is an important element in the recovery of a depression.
Aim The purpose is to examine whether focused guidance to improve sleep habits and circadian rhythms can speed up recovery and also prevent worsening of depression and thus prevent readmission.
Design and Methods All patients hospitalized at PCK (Psychiatric Center Copenhagen) with a unipolar depression, and referred to outpatient treatment at the Intensive outpatient unit for affective disorders) (IAA) at discharge, are eligible for inclusion. Patient agreeing to participate will be randomized to one of two groups. The standard care group consists of patients who will be asked to register their mental state on a daily basis (mood, sleep and exercise) in the electronical application Daybuilder (www.Daybuilder.com). This standard group will have weekly telephone contact with the investigators. The intervention group will also be asked to register their daily state in the Daybuilder app and have weekly telephone contact with the investigators. In addition to standard care this group will also receive individual guidance concerning the importance of stabilization of the sleep-wake cycle and sleep to recover from depression. The primary outcomes of the study are changes in self-rated mood and changes in Hamilton depression rating scores at baseline and endpoint in the two groups and number of readmissions. We expect that the intervention group will have a more rapid recovery of depression and have fewer readmissions. Furthermore, in a subset of patients, the levels of the sleep hormone melatonin, a biological marker of circadian rhythms, is measured, as a profile to establish the dim light melatonin onset (DLMO) at the start and end of the intervention. At total of 150 patients, 75 in each group will be included in the project over a three year period In this study we get the opportunity to see the isolated impact of focusing on sleep and circadian rhythm in the recovery from depression. We have coined this intervention Circadian Reinforcement Therapy (CRT).
Implications If the findings are positive, we expect to implement the intervention more systematically in the psychiatric services thereby improving the conditions of patients with depression by making the transition from in- to outpatient status less risky and more stable. In the long term perspective the intervention can underpin recovery from depression, and prevent relapse into depression and readmission in mental hospital.
- Conditions
- Depression
- Being tested
- Circadian Reinforcement Therapy, Standard treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Reinforcement TherapyBehavioural
Circadian reinforcement therapy plus electronical monitoring. Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms.
Standard treatmentBehavioural
Standard treatment plus electronical monitoring
| Study group | Role | What they receive |
|---|---|---|
| Circadian Reinforcement Therapy | Active comparator | Circadian reinforcement therapy Receives: Behavioral: Circadian Reinforcement Therapy |
| Standard treatment | Placebo comparator | Standard treatment Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood
Selfassessed mood rating from electronically entered data
Measured: 28 days
Secondary outcomes (2)
Readmission
Number of readmissions
Measured: 28 days
Interviewer based mood
Hamilton depression rating scale scores
Measured: 28 days
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 start1 Sep 2016
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Martiny, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679768
- Sponsor's protocol ID
- SAFEII
- Acronym
- SAFEII
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2016
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Danish National Archives
Publications
Aggestrup AS, Dunker Svendsen S, Norregaard L, Loventoft P, Knorr U, Frokjaer E, Hageman I, Faurholt-Jepsen M, Vedel Kessing L, Theil Skovgaard L, Martiny K. Electronic self-monitored morning depression scores are related to sleep timing and sleep length in depressed patients. NPJ Biol Timing Sleep. 2026 Sep 1;3(1):40. doi: 10.1038/s44323-026-00100-5.
PubMed 42680780Aggestrup AS, Svendsen SD, Praestegaard A, Loventoft P, Norregaard L, Knorr U, Dam H, Frokjaer E, Danilenko K, Hageman I, Faurholt-Jepsen M, Kessing LV, Martiny K. Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 27;10:e50072. doi: 10.2196/50072.
PubMed 37800194Dunker Svendsen S, Aggestrup AS, Norregaard LB, Loventoft P, Praestegaard A, Danilenko KV, Frost M, Knorr U, Hageman I, Vedel Kessing L, Martiny K. Circadian reinforcement therapy in combination with electronic self-monitoring to facilitate a safe post-discharge period of patients with depression by stabilizing sleep: protocol of a randomized controlled trial. BMC Psychiatry. 2019 Apr 25;19(1):124. doi: 10.1186/s12888-019-2101-z.
PubMed 31023274
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE II: Can Electronic Self-monitoring With Closed Loop Feedback Focusing on Regulation of the Sleep-wake Cycle Reduce Relapse of Depression After Discharge From a Psychiatric Ward?
- ClinicalTrials.gov ID
- NCT02679768
- Acronym / sponsor ID
- SAFEII / SAFEII
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 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.
Very little is known of depressed patients' mental state after being discharged from inpatient wards where they are provided with a sheltered environment with stable sleep wake cycle, regular meals, and regular physical and social activities. Our previous usability study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into patients' condition in the weeks after discharge. Results showed that patients over a four week period had significant day to day variations in self-rated mood and sleeping schedule and that the patients' sleep patterns were delayed with 45 minutes.
In the actual study, SAFE II, we are investigating whether an intervention with a strong focus on the circadian timing of daytime activities, and sleep, coined Circadian Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse into depression after discharge.
Detailed description
SAFE II Background Patients hospitalized with a depression are generally discharged within 4-6 weeks, but remain vulnerable, and not fully recovered at discharge, hence a majority will be referred to outpatient care. Often, however, patients have to wait for about 2 weeks from discharge to first visit in the outpatient clinic. Our clinical experience is that this period from discharge to start of outpatient care is associated with psychological uncertainty and often cause unstable daily routines for sleep, meals, social life, and exercise. This may result in aggravation of the depression with the associated risk of suicidal thoughts and readmission. Our first study "E-monitoring by depression - Safe I," illustrated these issues. Patients registered their state daily in an electronical application, for sleep, mood, and exercise. Among other things the study showed that the patients' sleep patterns were advanced to later in the evening and longer in the morning thus shifting the sleep-wake cycle to later. One possible explanation for this finding is that patients are not recovered from the depression when discharged and therefore are more vulnerable to changes. Another possible factor is that at home the patients do not have the same support to keep daily structure as during hospitalization. This project "Safe discharge - SafeII" is based on the experience from the first study and will investigate whether a focused intervention in the benefits of a stable sleep in the recovery of a depression can help prevent worsening of the depression in the waiting time for outpatient treatment. It is well documented that stable sleep and circadian rhythm is an important element in the recovery of a depression.
Aim The purpose is to examine whether focused guidance to improve sleep habits and circadian rhythms can speed up recovery and also prevent worsening of depression and thus prevent readmission.
Design and Methods All patients hospitalized at PCK (Psychiatric Center Copenhagen) with a unipolar depression, and referred to outpatient treatment at the Intensive outpatient unit for affective disorders) (IAA) at discharge, are eligible for inclusion. Patient agreeing to participate will be randomized to one of two groups. The standard care group consists of patients who will be asked to register their mental state on a daily basis (mood, sleep and exercise) in the electronical application Daybuilder (www.Daybuilder.com). This standard group will have weekly telephone contact with the investigators. The intervention group will also be asked to register their daily state in the Daybuilder app and have weekly telephone contact with the investigators. In addition to standard care this group will also receive individual guidance concerning the importance of stabilization of the sleep-wake cycle and sleep to recover from depression. The primary outcomes of the study are changes in self-rated mood and changes in Hamilton depression rating scores at baseline and endpoint in the two groups and number of readmissions. We expect that the intervention group will have a more rapid recovery of depression and have fewer readmissions. Furthermore, in a subset of patients, the levels of the sleep hormone melatonin, a biological marker of circadian rhythms, is measured, as a profile to establish the dim light melatonin onset (DLMO) at the start and end of the intervention. At total of 150 patients, 75 in each group will be included in the project over a three year period In this study we get the opportunity to see the isolated impact of focusing on sleep and circadian rhythm in the recovery from depression. We have coined this intervention Circadian Reinforcement Therapy (CRT).
Implications If the findings are positive, we expect to implement the intervention more systematically in the psychiatric services thereby improving the conditions of patients with depression by making the transition from in- to outpatient status less risky and more stable. In the long term perspective the intervention can underpin recovery from depression, and prevent relapse into depression and readmission in mental hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadian Reinforcement Therapy | Active comparator | Behavioral: Circadian Reinforcement TherapyCircadian reinforcement therapy |
| Standard treatment | Placebo comparator | Behavioral: Standard treatmentStandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major depression as defined in DSM-5
- Hospitalized at a psychiatric inpatient ward
- Age above 18
Key exclusion criteria (6 listed)
- Bipolar depression
- Suicidal plans or ideations (score of 2 or more on the HAM-D17 scale) item 3 or if investigator is unsure of level og suicidality
- Dementia or other organic brain damage that might influence ability to use the electronical monitoring system (Daybuilder) and the rules of the study
- Psychotic depression at time of inclusion.
- Abuse of alcohol or other drugs that might influence the ability to comply with study rules
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 |
|---|---|---|
| Circadian Reinforcement TherapyCircadian reinforcement therapy plus electronical monitoring. Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms. | Behavioural | Circadian Reinforcement Therapy |
| Standard treatmentStandard treatment plus electronical monitoring | Behavioural | Standard treatment |
Primary outcome
Mood
Time frame: 28 days
Selfassessed mood rating from electronically entered data
2 secondary outcomes
Readmission
Time frame: 28 days
Interviewer based mood
Time frame: 28 days
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 25 Feb 2026.
- Derived from this study: PubMed 42680780Aggestrup AS, Dunker Svendsen S, Norregaard L, Loventoft P, Knorr U, Frokjaer E, Hageman I, Faurholt-Jepsen M, Vedel Kessing L, Theil Skovgaard L, Martiny K. Electronic self-monitored morning depression scores are related to sleep timing and sleep length in depressed patients. NPJ Biol Timing Sleep. 2026 Sep 1;3(1):40. doi: 10.1038/s44323-026-00100-5.
- Derived from this study: PubMed 37800194Aggestrup AS, Svendsen SD, Praestegaard A, Loventoft P, Norregaard L, Knorr U, Dam H, Frokjaer E, Danilenko K, Hageman I, Faurholt-Jepsen M, Kessing LV, Martiny K. Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 27;10:e50072. doi: 10.2196/50072.
- Derived from this study: PubMed 31023274Dunker Svendsen S, Aggestrup AS, Norregaard LB, Loventoft P, Praestegaard A, Danilenko KV, Frost M, Knorr U, Hageman I, Vedel Kessing L, Martiny K. Circadian reinforcement therapy in combination with electronic self-monitoring to facilitate a safe post-discharge period of patients with depression by stabilizing sleep: protocol of a randomized controlled trial. BMC Psychiatry. 2019 Apr 25;19(1):124. doi: 10.1186/s12888-019-2101-z.
- Individual participant dataSharing planned: Yes. The Danish National Archives
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Reinforcement Therapy and Standard treatment in people with Depression, run by University Hospital Bispebjerg and Frederiksberg 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 3 inclusion and 6 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 25 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
Mood (time frame: 28 days). 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 NCT02679768, which also lists 3 linked publications.
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 25 Feb 2026.