Prospective

Mandy Yu

Department of Psychiatry, 7/F Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, NT

852-26367593

mandyyu@cuhk.edu.hk

The Chinese University of Hong Kong

Prof. Wing Yun Kwok

Department of Psychiatry, 7/F Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, NT

852-26367593

ykwing@cuhk.edu.hk

The Chinese University of Hong Kong

一項在持續受睡眠問題困擾的抑鬱症病患者中進行的單盲(評估員)、平行組別和隨機對照的睡眠認知行為治療臨床研究

Yes

2012-12-06

Behavior

Cognitive-behavioral therapy for insomnia (CBT-I) and imagery rehearsal therapy (IRT)

6 sessions in 6 weeks

Trial interventions
Trial interventions will be provided at Sleep Assessment Unit (SAU) of Shatin Hospital.
 Study subjects in the sleep-focused treatment plus TAU group will receive 6 weekly individual sessions with each lasting for 45 minutes, which will be provided by trained personnel under close supervision by an experienced clinical psychologist.
 For the subjects in the TAU group, they will be scheduled for 6 weekly 45-minitue sessions, which will be maintained as close to standard care as possible, including an interview with a research psychiatrist to discuss their depressive symptoms, a simple physical check-up (e.g. blood pressure measurements, 12-lead electronic electrocardiograms), completing questionnaire measures with a research staff at SAU of SH. The research psychiatrist will mainly adopt active listening to the subjects during the clinical interview, following a structured checklist, which outlines the topics that are allowed in the discussion. Brief discussion of basic sleep hygiene will be allowed only as outlined in the study protocol, whereas active components of CBT-I and IRT will not be included in the sessions for the subjects in the TAU group. To ensure that the behavioural sleep recommendations are not provided to the subjects in TAU group, the clinical interviews will be randomly selected for video-taping and reviewed by the co-investigator. Any discrepancy will be discussed and resolved with the research psychiatrist during the weekly research meeting.

A patient who meets all the following criteria will be eligible for inclusion in the study: (i) Chinese aged 18-65 years old, which is the general age range for adult population (given that age may potentially have an effect on sleep patterns and sleep problems, older adults and elderly (age > 65 years) will not be recruited into the study); (ii) being capable of giving informed consent; (iii) being able to comply with the study protocol; (iv) meeting the diagnostic criteria of MDD according to Mini International Neuropsychiatric Interview (MINI); (v) reporting sleep disturbances with a duration of at least six months, including a. frequent insomnia (as defined by a total score of 8 or above on the Insomnia Severity Index, ISI), and significant distress or impairment of daytime functioning (as defined by a score of at least 2 on item 5 of the ISI), and/or b. frequent nightmares (as defined by having nightmare at least once per week reported in Nightmare Frequency Questionnaire (NFQ) and waking distress or daytime impairment associated with nightmares [as defined by a positive response in the 1st item (yes/no) in Nightmare Effect Survey (NES)]. (vi) a score of at least 14 on the 17-item Hamilton Rating Scale for Depression (HRSD17); (vii) has been previously prescribed at least two types of antidepressants for at least 6 weeks each without producing a significant clinical improvement.

A patient who meets one or more of the following criteria will be excluded from the study: (i) a current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia, personality disorder, posttraumatic stress disorder (PTSD), mental retardation, or organic mental disorder; (ii) the patient, in the opinion of the investigator, has a significant risk of suicide, or has a suicidality level rated as moderate or above in the MINI Suicidality Module, or has made a suicide attempt in the past three months at the entry of the study; (iii) the patient has been enrolled in any other clinical trial investigational products within one month at the entry of the study; (iv) having been or currently receiving any structured psychotherapy; (v) significant medical conditions that may interfere with sleep and/or may compromise regular schedule of trial intervention; (vi) comorbid sleep problems, which may potentially contribute to a disruption in sleep quality and continuity, such as obstructive sleep apnea (OSA, as defined by apnea hypopnea index >=15/hr), periodic leg movement syndrome (PLMS, as defined by PLMI >=15/hr), narcolepsy; (vii) night shift worker; (viii) with hearing or speech deficit.

18

65

Both Male and Female

Randomized

Placebo

Single-blind

Parallel

No

Yes

NA