Chronotherapy for Depressive Episodes

December 30, 2025 updated by: St. Olavs Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Trondheim, Norway
        • Recruiting
        • St. Olavs Hospital, Nidaros DPS
        • Principal Investigator:
          • Knut Langsrud, PhD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chronotherapy + treatment as usual
Behavioral: Chronotherapy
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.
Behavioral: Treatment as usual
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.
Active Comparator: Treatment as usual
medication, cognitive behavioral therapy, and other psychotherapies.
Behavioral: Treatment as usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
Time Frame: 1 week 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.
1 week after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.
Time Frame: 1 week 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.
1 week after randomization
Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization
Time Frame: 2 weeks 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.
2 weeks after randomization
Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.
Time Frame: 4 weeks 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.
4 weeks after randomization
Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization
Time Frame: 8 weeks 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.
8 weeks after randomization
Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization
Time Frame: 24 weeks 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.
24 weeks after randomization
Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization
Time Frame: 52 weeks 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.
52 weeks after randomization
Between-group difference in self-reported anxiety symptoms at week 1 after randomization
Time Frame: 1 week 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.
1 week after randomization
Between-group difference in self-reported anxiety symptoms at week 2 after randomization.
Time Frame: 2 weeks 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.
2 weeks after randomization
Between-group difference in self-reported anxiety symptoms at week 4 after randomization
Time Frame: 4 weeks 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.
4 weeks after randomization
Between-group difference in self-reported anxiety symptoms at week 8 after randomization
Time Frame: 8 weeks 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.
8 weeks after randomization
Between-group difference in self-reported anxiety symptoms at week 24 after randomization
Time Frame: 24 weeks 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.
24 weeks after randomization
Between-group difference in self-reported anxiety symptoms at week 52 after randomization
Time Frame: 52 weeks 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.
52 weeks after randomization
Between-group difference in self-reported insomnia symptoms at week 1 after randomization
Time Frame: 1 week 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.
1 week after randomization
Between-group difference in self-reported insomnia symptoms at week 2 after randomization.
Time Frame: 2 weeks 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.
2 weeks after randomization
Between-group difference in self-reported insomnia symptoms at week 4 after randomization
Time Frame: 4 weeks 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.
4 weeks after randomization
Between-group difference in self-reported insomnia symptoms at week 8 after randomization
Time Frame: 8 weeks 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.
8 weeks after randomization
Between-group difference in self-reported insomnia symptoms at week 24 after randomization
Time Frame: 24 weeks 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.
24 weeks after randomization
Between-group difference in self-reported insomnia symptoms at week 52 after randomization.
Time Frame: 52 weeks 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.
52 weeks after randomization
Prospective daily sleep-wake pattern at day 3 after randomization
Time Frame: 3 days 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.
3 days after randomization.
Prospective daily sleep-wake pattern at day 4 after randomization.
Time Frame: 4 days 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.
4 days after randomization.
Prospective daily sleep-wake pattern at week 1 after randomization.
Time Frame: 1 week 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.
1 week after randomization.
Prospective daily sleep-wake pattern at week 2 after randomization.
Time Frame: 2 weeks 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.
2 weeks after randomization.
Prospective daily sleep-wake pattern at week 4 after randomization.
Time Frame: 4 weeks 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.
4 weeks after randomization.
Prospective daily sleep-wake pattern at week 8 after randomization
Time Frame: 8 weeks 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.
8 weeks after randomization.
Prospective daily sleep-wake pattern at week 24 after randomization.
Time Frame: 24 weeks 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.
24 weeks after randomization.
Prospective daily sleep-wake pattern at week 52 after randomization
Time Frame: 52 weeks 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.
52 weeks after randomization.
Chronotype at week 8 after randomization.
Time Frame: 8 weeks 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).
8 weeks after randomization
Work and social adjustment at week 1.
Time Frame: 1 week after randomization.
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.
1 week after randomization.
Work and social adjustment at week 2.
Time Frame: 2 weeks after randomization.
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.
2 weeks after randomization.
Work and social adjustment at week 4.
Time Frame: 4 weeks after randomization
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.
4 weeks after randomization
Work and social adjustment at week 8.
Time Frame: 8 weeks after randomization
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.
8 weeks after randomization
Work and social adjustment at week 24
Time Frame: 24 weeks after randomization
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.
24 weeks after randomization
Work and social adjustment at week 52
Time Frame: 52 weeks after randomization
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.
52 weeks after randomization
General health and health-related quality of life at week 1
Time Frame: 1 week 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.
1 week after randomization.
General health and health-related quality of life at week 2.
Time Frame: 2 weeks 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.
2 weeks after randomization.
General health and health-related quality of life at week 4.
Time Frame: 4 weeks 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.
4 weeks after randomization.
General health and health-related quality of life at week 8
Time Frame: 8 weeks 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.
8 weeks after randomization.
General health and health-related quality of life at week 24
Time Frame: 24 weeks 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.
24 weeks after randomization.
General health and health-related quality of life at week 52.
Time Frame: 52 weeks 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.
52 weeks after randomization.
Patient satisfaction and experienced negative effects at week 4 after randomization
Time Frame: 4 weeks 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.
4 weeks after randomization.
Serious adverse events will be assessed after 52 weeks after randomization.
Time Frame: 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.
52 weeks after randomization.
Use of health care services at 52 weeks after randomization.
Time Frame: 52 weeks after randomization
Assessed through questionnaires and health care records.
52 weeks after randomization
Use of health care services at 5 years after randomization
Time Frame: 5 years after randomization
Assessed through questionnaires and health care records.
5 years after randomization
Use of health care services at 10 years after randomization.
Time Frame: 10 years after randomization.
Assessed through questionnaires and health care records.
10 years after randomization.
Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization
Time Frame: 3 days 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.
3 days after randomization
Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization
Time Frame: 4 days 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.
4 days after randomization
Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization
Time Frame: 14 days 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.
14 days after randomization
Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization
Time Frame: 4 weeks 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.
4 weeks after randomization
Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization
Time Frame: 8 weeks 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.
8 weeks after randomization
Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization
Time Frame: 24 weeks 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.
24 weeks after randomization
Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization
Time Frame: 52 weeks 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.
52 weeks after randomization
Subjective sleepiness during sleep deprivation
Time Frame: Day 3-4 after randomization
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.
Day 3-4 after randomization
Expectations to the interventions at baseline
Time Frame: Day 0 after randomization
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)
Day 0 after randomization
Quality-adjusted life years (QALY) at week 1 after randomization
Time Frame: 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.
Week 1 after randomization
Quality-adjusted life years (QALY) at week 2 after randomization
Time Frame: 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.
Week 2 after randomization
Quality-adjusted life years (QALY) at week 4 after randomization
Time Frame: 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.
Week 4 after randomization
Quality-adjusted life years (QALY) at week 8 after randomization
Time Frame: 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.
Week 8 after randomization
Quality-adjusted life years (QALY) at week 24 after randomization
Time Frame: 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.
Week 24 after randomization
Quality-adjusted life years (QALY) at week 52 after randomization
Time Frame: 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.
Week 52 after randomization
Prospective daily sleep-wake pattern at day -7 before randomization.
Time Frame: 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.
Day -7 before randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 480812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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