AzTrials
AzTrials

Depressive EpisodeNCT05691647

Chronotherapy for Depressive Episodes

A study testing Chronotherapy and Treatment as usual in people with Depressive Episode, run by St. Olavs Hospital at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Depressive Episode
What is being tested?
Chronotherapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteNorway
Study dates
12 Apr 2023to Jan 2040
Phase
Interventional
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization:

  • Being 18 years or older
  • Willing and able to provide a written informed consent
  • Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology.
  • The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6.
  • Must be able to communicate in a Scandinavian language

Exclusion criteria. Patients are considered ineligible for participation if any of the following are present:

  • Illnesses and treatments where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression, ECT treatment).
  • Known pregnancy.
  • Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3).
  • Individuals with a known psychotic disorder
  • Shiftwork or other related social or work circumstances that inhibit participation
  • Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Knut Langsrud, PhD, MD contact

+47 92647191

knut.langsrud@stolav.no

Norway1 site, 1 recruiting

  • St. Olavs Hospital, Nidaros DPS

    Trondheim

    Knut Langsrud, PhD, MD

    Recruiting

Other trials in Norway

About this study

Official title: Chronotherapy for Patients With a Depressive Episode in a Public Mental Health Care Clinic in Norway: A Randomized Controlled Trial

Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a mental health care clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.

Being tested
Chronotherapy, Treatment as usual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChronotherapyBehavioural

    Chronotherapy involves three different interventions. Sleep deprivation/wake therapy will be conducted for 34 hours. To assist wake and to ensure that the participants adhere to the sleep deprivation, outpatients will be admitted to a one-night stay at the inpatient ward that is connected to the outpatient clinic at Nidaros DPS. Patients already admitted to inpatient treatment will be temporary transferred to the ward selected to oversee the sleep deprivation. Upon discharge, participants are encouraged to adhere to the sleep schedule which presents the sleep-wake phase advancement and later stabilization of the sleep-wake phase. Light therapy is provided for half an hour every day from day four in the study. In addition to the chronotherapeutic interventions, the participants will receive treatment as usual (TAU) with their assigned therapist.

  • Treatment as usualBehavioural

    Participants allocated to receive TAU alone, will receive standard treatment for a depressive episode in the outpatient or the inpatient clinic. This study will not give restrictions or guidelines on how this treatment should be performed. The TAU-group will receive the treatment the responsible therapist considers and evaluate best fitting in the situation. Typical interventions administered in therapy for a depressive episode includes medication, cognitive behavioral therapy, and other psychotherapies.

Study groups in NCT05691647
Study groupRoleWhat they receive
Chronotherapy + treatment as usualExperimentalNot described
Receives: Behavioral: Chronotherapy; Behavioral: Treatment as usual
Treatment as usualActive comparatormedication, cognitive behavioral therapy, and other psychotherapies.
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 1 week after randomization

Secondary outcomes (60)

  1. Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 1 week after randomization

  2. Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 2 weeks after randomization

  3. Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 4 weeks after randomization

  4. Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 8 weeks after randomization

  5. Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 24 weeks after randomization

  6. Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization

    Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.

    Measured: 52 weeks after randomization

  7. Between-group difference in self-reported anxiety symptoms at week 1 after randomization

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 1 week after randomization

  8. Between-group difference in self-reported anxiety symptoms at week 2 after randomization.

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 2 weeks after randomization

  9. Between-group difference in self-reported anxiety symptoms at week 4 after randomization

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 4 weeks after randomization

  10. Between-group difference in self-reported anxiety symptoms at week 8 after randomization

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 8 weeks after randomization

  11. Between-group difference in self-reported anxiety symptoms at week 24 after randomization

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 24 weeks after randomization

  12. Between-group difference in self-reported anxiety symptoms at week 52 after randomization

    Here assessed with the General Anxiety Disorder (GAD-7), a 7 items self-report scale for central symptoms of anxiety over the last 14 days. The range is 0 to 21, with higher scores indicating more severe anxiety.

    Measured: 52 weeks after randomization

  13. Between-group difference in self-reported insomnia symptoms at week 1 after randomization

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 1 week after randomization

  14. Between-group difference in self-reported insomnia symptoms at week 2 after randomization.

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 2 weeks after randomization

  15. Between-group difference in self-reported insomnia symptoms at week 4 after randomization

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 4 weeks after randomization

  16. Between-group difference in self-reported insomnia symptoms at week 8 after randomization

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 8 weeks after randomization

  17. Between-group difference in self-reported insomnia symptoms at week 24 after randomization

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 24 weeks after randomization

  18. Between-group difference in self-reported insomnia symptoms at week 52 after randomization.

    Here assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

    Measured: 52 weeks after randomization

  19. Prospective daily sleep-wake pattern at day 3 after randomization

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 3 days after randomization.

  20. Prospective daily sleep-wake pattern at day 4 after randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 4 days after randomization.

  21. Prospective daily sleep-wake pattern at week 1 after randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 1 week after randomization.

  22. Prospective daily sleep-wake pattern at week 2 after randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 2 weeks after randomization.

  23. Prospective daily sleep-wake pattern at week 4 after randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 4 weeks after randomization.

  24. Prospective daily sleep-wake pattern at week 8 after randomization

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 8 weeks after randomization.

  25. Prospective daily sleep-wake pattern at week 24 after randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 24 weeks after randomization.

  26. Prospective daily sleep-wake pattern at week 52 after randomization

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: 52 weeks after randomization.

  27. Chronotype at week 8 after randomization.

    Here assessed with the Reduced Morningness - Eveningness Questionnaire (rMEQ), a widely used measure of chronotype i.e. time preference for daily activities, including bed-times. The rMEQ has five items yielding scores from 4 to 25, with lower scores indicating "eveningness" and higher scores indicating "morningness". Higher scores indicate higher levels of morningness. Scores can be divided into five categories: definitely evening type (score <8), moderately evening type (Score 8-11), neither type (score 12-17), moderately evening type (score 18-21), and definitely morning type (score >21).

    Measured: 8 weeks after randomization

  28. Work and social adjustment at week 1.

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 1 week after randomization.

  29. Work and social adjustment at week 2.

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 2 weeks after randomization.

  30. Work and social adjustment at week 4.

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 4 weeks after randomization

  31. Work and social adjustment at week 8.

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 8 weeks after randomization

  32. Work and social adjustment at week 24

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 24 weeks after randomization

  33. Work and social adjustment at week 52

    Assessed with the Work and Social Adjustment Scale (WSAS). WSAS is a self-administered questionnaire that measures the subjective experience of functionality in work and social environments. The 5 items are rated on an 8-point Likert scale. Total scores range from 0-40, with a higher score indicating more functional impairment.

    Measured: 52 weeks after randomization

  34. General health and health-related quality of life at week 1

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 1 week after randomization.

  35. General health and health-related quality of life at week 2.

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 2 weeks after randomization.

  36. General health and health-related quality of life at week 4.

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 4 weeks after randomization.

  37. General health and health-related quality of life at week 8

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 8 weeks after randomization.

  38. General health and health-related quality of life at week 24

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 24 weeks after randomization.

  39. General health and health-related quality of life at week 52.

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: 52 weeks after randomization.

  40. Patient satisfaction and experienced negative effects at week 4 after randomization

    A self-report measure was developed to assess the subjective experiences of patients in the study. The measure includes items to assess whether there have been positive and negative effects of the interventions and will include a free-text space to elaborate if none of the expected effects are experienced.

    Measured: 4 weeks after randomization.

  41. Serious adverse events will be assessed after 52 weeks after randomization.

    Adverse events will be reported to the study team continuously throughout the study period, and will be registered. Any serious adverse events will be reported.

    Measured: 52 weeks after randomization.

  42. Use of health care services at 52 weeks after randomization.

    Assessed through questionnaires and health care records.

    Measured: 52 weeks after randomization

  43. Use of health care services at 5 years after randomization

    Assessed through questionnaires and health care records.

    Measured: 5 years after randomization

  44. Use of health care services at 10 years after randomization.

    Assessed through questionnaires and health care records.

    Measured: 10 years after randomization.

  45. Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 3 days after randomization

  46. Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84. On day 4, sleep items will be excluded from the questionnaire.

    Measured: 4 days after randomization

  47. Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 14 days after randomization

  48. Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 4 weeks after randomization

  49. Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 8 weeks after randomization

  50. Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 24 weeks after randomization

  51. Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization

    Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

    Measured: 52 weeks after randomization

  52. Subjective sleepiness during sleep deprivation

    Assessed with the Karolinska Sleepiness Scale (KSS), a 9-item Likert scale, scored from 1 (=extremely alert) to 9 (=extremely sleepy-fighting sleep). The assessment will take place every second hour during the sleep deprivation for the intervention group.

    Measured: Day 3-4 after randomization

  53. Expectations to the interventions at baseline

    Assessed with the Stanford Expectations of Treatment Scale (SETS), a 6-item questionnaire that assesses participants' positive and negative expectations to the interventions on a Likert scale from 1 (strongly disagree) to 7 (strongly agree)

    Measured: Day 0 after randomization

  54. Quality-adjusted life years (QALY) at week 1 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 1 after randomization

  55. Quality-adjusted life years (QALY) at week 2 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 2 after randomization

  56. Quality-adjusted life years (QALY) at week 4 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 4 after randomization

  57. Quality-adjusted life years (QALY) at week 8 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 8 after randomization

  58. Quality-adjusted life years (QALY) at week 24 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 24 after randomization

  59. Quality-adjusted life years (QALY) at week 52 after randomization

    Assessed with the EQ-5D-5L. The EQ-5D-5L is a self-administered questionnaire that assesses general health and health-related quality of life at the day of measurement. The 5 items are rated on a 5-point Likert scale in addition to a 0-100 rating of overall experienced health condition.

    Measured: Week 52 after randomization

  60. Prospective daily sleep-wake pattern at day -7 before randomization.

    Here assessed with the Consensus Sleep Dairy and actigraphy, which will be completed by the participant at baseline and each follow-up point for 14 days.

    Measured: Day -7 before randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start12 Apr 2023
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2040 (estimated)

Resources

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
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05691647
Sponsor's protocol ID
480812
Status last verified
Dec 2025
First submitted
16 Dec 2022
Last updated
31 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data that underlie the results will be available after publication of the final version of the trial to researchers from accredited research institutions. Access to data will be limited to investigators who provide a methodologically sound proposal and will be for a specified time period (commencing about 3 months after publication and ending after five years). To ensure GDPR compliance, data processing must be covered by the 'Standard Contractual Clauses' from the European Commission, that data requesters have to sign. Proposals and requests for data access should be directed to the principal investigator.

Publications

  • Ramfjord LS, Kahn N, Langsrud K, Halvorsen JOO, Morken G, Saksvik S, Engvik LSS, Lydersen S, Kallestad H. Chronotherapy for patients with a depressive episode treated in a public outpatient mental healthcare clinic in Norway: protocol for a randomised controlled trial. BMJ Open. 2024 Jan 3;14(1):e076039. doi: 10.1136/bmjopen-2023-076039.

    PubMed 38171633

Questions about this trial

What is this clinical trial studying?

A study testing Chronotherapy and Treatment as usual in people with Depressive Episode, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. 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 Norway. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Knut Langsrud, PhD, MD (+47 92647191, knut.langsrud@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization (time frame: 1 week after randomization). 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 NCT05691647, 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 31 Dec 2025.

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