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The Advance Project - Advancing Sleep Timing to Improve Depression

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

150 patients with moderate to severe depression, recently discharged from a psychiatric ward and now recieving treatment at an outpatient unit at Mental Health Center Copenhagen, will be randomised in to two groups. A treatment ad usual (TAU) group and an Advance-group. The Advance-group will receive a psychotherapeutic intervention focusing on advancing sleep timing to improve depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate to major depression (DSM-V)

Discharge from psychiatric ward within last 30 days

Sleep onset and/or sleep off-set delayed minimum 1 hour based on the last three days, comparred to sleep in the last week of admittance at the psychiatric ward.

Disqualifiers

Psychotic depression.

Cognitive problems making participation difficult.

Substance abuse (e.g. alcohol).

Increased suicidal risk.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CRT-Advance

    Behavioral

    Psychotherapy with focus on advancing sleep timing, using diaries on sleep and zeitgebers.

  • Treatment as usual

    Behavioral

    Treatment as usual in the outpatient psychiatric unit.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Advance-groupExperimental treatment 1 intervention
Group B: Control-groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Beck Depression Inventory II (BDI-II)

Patients will do af self-rating with the Beck Depression IInventory-II self-rating scale. Minimum score is 0, maximum score is 63. A higher score indicates a worsening of depression symptoms

Time frame
at inclusion, at two weeks, at fourweeks, at six weeks, and at endpoint (after eight weeks)

Secondary outcomes

1

Changes in sleep-midpoint

Measured both with sleep diaries and with actigraphy

Time frame
At inclusion and at endpoint (after eight weeks)
2

Changes in time for sleep onset

Measured both with sleep diaries and with actigraphy

Time frame
At inclusion and at endpoint (after eight weeks)
3

Changes in time for sleep wake-up

Measured both with sleep diaries and with actigraphy

Time frame
At inclusion and at endpoint (after eight weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Source ClinicalTrials.gov
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