NCT03775148

A Transdiagnostic Sleep and Circadian Treatment for Depression

Completed NA Last updated 5 November 2019

What this trial tests

NA trial testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in Depression in 37 participants. Completed in 31 August 2019.

Timeline

1 January 2019

Primary endpoint
31 August 2019

31 August 2019

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	37
Start date	1 January 2019
Primary completion	31 August 2019
Estimated completion	31 August 2019
Sites	1 location across Hong Kong

Drugs / interventions tested

• Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Conditions studied

• Depression — all drugs for Depression →
• Insomnia — all drugs for Insomnia →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Depression or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a range of psychological disorders, especially MDD. MDD is a major public health concern and a leading cause of disability worldwide. A shift in treatment perspectives, from a disorder-specific approach to a transdiagnostic approach, has been proposed. While the disorder-specific approach tends to understand and treat different mental disorders as independent psychological problems, the transdiagnostic approach aims to identify common clinical features (e.g. sleep disturbances) across a range of psychological disorders. The transdiagnostic approach would potentially facilitate timely dissemination of evidence-based psychological treatments and contribute to significant public health implications.

This study will be a pilot randomized controlled trial on the efficacy of TranS-C for MDD. TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 40 eligible participants will be randomly assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in the TranS-C group will receive TranS-C once per week for 6 consecutive weeks respectively. The group treatment will be delivered by a clinical psychology trainee under the supervision of a clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil questionnaires before the treatment commences, 1-week, and 12-week after the treatment sessions are completed. The CAU group will complete the same set of online/paper-and-pencil questionnaires during the same periods.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.