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Completed

NCT Number: NCT03000894

CBT-I as Early Intervention of Mood Disorders

This study aims to investigate the effectiveness of transdiagnostic nurse-administered 4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care, compared to standard care alone, for improving sleep and daytime function, enhancing recovery, preventing relapses, and reducing medication burden in patients with the first episode of mood disorders.

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Key information

Conditions

Insomnia Due to Mental Disorder Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hong Kong residents
  • Aged ≥ 18 years
  • Able to to communicate in Cantonese and write in Chinese
  • First episode of depressive or bipolar disorders according to the DSM-5 diagnostic criteria
  • Having received psychiatric treatment for less than 12 months
  • Meeting the DSM-5 diagnostic criteria for insomnia disorder for at least 1 month, instead of at least 3 months, as in criterion D.

Exclusion criteria

  • Significant cognitive impairments and psychotic symptoms, based on a Mini-mental State Examination score of 23 or below and the Positive and Negative Syndrome Scale items on delusions, conceptual disorganization, and hallucinatory behavior at moderate severity or above
  • A diagnosis of schizophrenia, delusional disorder, neurocognitive disorders, or learning disability
  • Having a highly unstable medical or psychiatric condition (including strong suicidal risk) that requires hospitalization
  • Having an untreated sleep disorder, including narcolepsy, obstructive sleep apnea, and periodic leg movement disorder
  • Past or current treatment with CBT-I
  • Having a fear of speaking in a group setting or refusal to give informed consent
  • Refuse to give informed consent

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.

Primary outcomes

  1. Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

Secondary outcomes

  1. Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  2. Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  3. Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  4. Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  5. Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  6. Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  7. Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  8. Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  9. Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  10. The number and type of relapses

    Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  11. The number of clinic visits and hospitalizations

    Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  12. Change of subjects' perceived stress measured by Perceived Stress Scale

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  13. Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  14. Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  15. Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  16. Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale

    Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  17. Change of subjects' credibility to treatment measured by Credibility of treatment rating scale

    Time frame: Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)

  18. Prescribed medication burden

    Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

  19. Subjects' satisfaction to CBT-I measured by treatment satisfaction scale

    Time frame: Immediate post-treatment (around 8-week post-baseline)

  20. Subjects' adherence to CBT-I measured by treatment adherence scale

    Time frame: Immediate post-treatment (around 8-week post-baseline)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Kowloon Hospital, Hong Kong

Registry information

Official study title

Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2016
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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