The Advance Project - Advancing Sleep Timing to Improve Depression

NCT06097221 | Recruiting DMC

• 1 other identifier: ADVANCE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

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

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

Secondary Outcomes (3)

• Changes in sleep-midpoint

  At inclusion and at endpoint (after eight weeks)

• Changes in time for sleep onset

  At inclusion and at endpoint (after eight weeks)

• Changes in time for sleep wake-up

  At inclusion and at endpoint (after eight weeks)

Study Arms (2)

Advance-group

EXPERIMENTAL

The group will recieve 8 hours of psychotherapy with focus on advancing sleep timing, besides their treatment as usual.

Behavioral: CRT-Advance

Control-group

ACTIVE COMPARATOR

Treatment as usual at the outpaitent unit.

Behavioral: Treatment as usual

Interventions

CRT-Advance BEHAVIORAL

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

Advance-group

Treatment as usual BEHAVIORAL

Treatment as usual in the outpatient psychiatric unit.

Control-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychotic depression.
• Cognitive problems making participation difficult.
• Substance abuse (e.g. alcohol).
• Increased suicidal risk.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Mental Health Center Copenhagen

Copenhagen, Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Klaus Martiny, Professor

  Mental Health Center Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Anne Sofie Kvist Houby, MD

CONTACT

28780878; anne.sofie.kvist.houby@regionh.dk

Klaus Martiny, Professor

CONTACT

klaus.martiny@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)