Sleep, Wake and Light Therapy for Depression

King's College London1 site in 1 country60 target enrollmentJanuary 18, 2018

ConditionsDepression Depressive Disorder, Major Depression, Unipolar Depression Moderate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: King's College London
Enrollment: 60
Locations: 1
Primary Endpoint: Number of participants recruited per month/Adherence to the protocol
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to determine if altering the pattern of one's sleep and having light therapy can speed up the treatment of depression. In the UK, the large majority of patients with depression in the NHS are treated in the community, and one of the major objectives of the study one is to determine if this therapy is a practical treatment in the community. We will be comparing two treatments:

Sleep Therapy and a Light Box: Participants will be given information and advice on how to get a good night's sleep. Participants will be given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when a person gets up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
Wake therapy and a Light Box: Participants will be helped to change the pattern of sleep by depriving participants of sleep for one night. Participants will go bed at 5pm on the following day for 8 hours and get up at 1am. Participants' sleep will then be advanced by 2 hours each night for the next three nights. Participants will be also given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when participants get up. Participants may continue to have any treatment as usual (for example medication or talking therapies).

Detailed Description

* Participants will be given a wristband (Actigraph) * Participants will be asked to complete various questionnaires and be interviewed at 1 week, 2 weeks, 4 weeks, 8 weeks and at 6 months after starting. * Participants will be asked to make 6 extra visits to the research team at the hospital over and above those needed for normal care.

Registry

clinicaltrials.gov

Start Date

January 18, 2018

End Date

September 23, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33).
•Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981).
•Age 18-65
•Able to give informed consent
•Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial.

Exclusion Criteria

•Current diagnosis of Seasonal Affective Disorder
•Current diagnosis of anorexia nervosa or bulimia.
•Current diagnosis of an obsessive compulsive or related disorder
•Current diagnosis of post-traumatic stress disorder
•History of schizophrenia, schizoaffective disorder or bipolar disorder
•Severe cognitive impairment, dementia, intellectual disability or organic brain disorder.
•History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months.
•Borderline Personality Disorder or other personality disorder considered to be the main problem.
•Duration of depression more than 2 years.
•Significant risk of suicide that requires hospitalisation.

Outcomes

Primary Outcomes

Number of participants recruited per month/Adherence to the protocol

Time Frame: Week 1

To compare the rate of recruitment and adherence to the treatments in both groups

Secondary Outcomes

Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Euroquol 5D (1990) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
To check the amount of current psychotherapy use(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Daily sleep diary(3 days pre-randomisation and 7 days post-randomisation)
To check the amount of current antidepressant use(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Credibility and Expectancy Questionnaire (Devilly, 2000).(Baseline)
Morning/Evening Questionnaire(3 days pre-randomisation)
MINI International Neuropsychiatric Interview Version 5.0(Baseline)
Clinical Global Impression and Improvement Scale (Guy, 1976)(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
Wrist actigraph from GeneActiv daily (Physiological parameter)(3 days pre-randomisation and 7 days post-randomisation.)
Hamilton Depression Rating Scale(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)