Insomnia and Nightmare
Conditions
Interventions
Two groups:Cognitive-behavioral therapy for insomnia (CBT-I) versus imagery rehearsal therapy (IRT)
Sponsors
Health and Health Services Research Fund
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: A patient who meets all the following criteria will be eligible for inclusion in the study: 1. 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); 2. being capable of giving informed consent; 3. being able to comply with the study protocol; 4. meeting the diagnostic criteria of MDD according to Mini International Neuropsychiatric Interview (MINI); 5. reporting sleep disturbances with a duration of at least six months, including (1) 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 (2) 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)]. 6. a score of at least 14 on the 17-item Hamilton Rating Scale for Depression (HRSD17); 7. has been previously prescribed at least two types of antidepressants for at least 6 weeks each without producing a significant clinical improvement.
Exclusion criteria
Exclusion criteria: A patient who meets one or more of the following criteria will be excluded from the study: 1. 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; 2. 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; 3. the patient has been enrolled in any other clinical trial investigational products within one month at the entry of the study; 4. having been or currently receiving any structured psychotherapy; 5. significant medical conditions that may interfere with sleep and/or may compromise regular schedule of trial intervention; 6. 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; 7. night shift worker; (viii) with hearing or speech deficit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of insomnia and nightmare; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-rated and clinician-rated severity of depressive symptoms, suicidal ideation and quality of life; | — |
Countries
China
Contacts
Public ContactProf. Wing Yun Kwok
Outcome results
None listed