<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000894</url>
  </required_header>
  <id_info>
    <org_study_id>UW 16-057</org_study_id>
    <nct_id>NCT03000894</nct_id>
  </id_info>
  <brief_title>CBT-I as Early Intervention of Mood Disorders</brief_title>
  <official_title>Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kowloon Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <brief_summary>
    <textblock>
      This study aims to investigate the effectiveness of transdiagnostic nurse-administered&#xD;
      4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care,&#xD;
      compared to standard care alone, for improving sleep and daytime function, enhancing&#xD;
      recovery, preventing relapses, and reducing medication burden in patients with the first&#xD;
      episode of mood disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number and type of relapses</measure>
    <time_frame>3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of clinic visits and hospitalizations</measure>
    <time_frame>3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' perceived stress measured by Perceived Stress Scale</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale</measure>
    <time_frame>Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of subjects' credibility to treatment measured by Credibility of treatment rating scale</measure>
    <time_frame>Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescribed medication burden</measure>
    <time_frame>3-month post-baseline, 6-month post-baseline, and 12-month post-baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' satisfaction to CBT-I measured by treatment satisfaction scale</measure>
    <time_frame>Immediate post-treatment (around 8-week post-baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' adherence to CBT-I measured by treatment adherence scale</measure>
    <time_frame>Immediate post-treatment (around 8-week post-baseline)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Insomnia Due to Mental Disorder</condition>
  <arm_group>
    <arm_group_label>CBT-I plus standard care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group CBT-I will receive both CBT-I and standard care. CBT-I covers sleep-wake cycle as well as sleep hygiene education, activity scheduling, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Standard care will include those treatments provided by the psychiatrists according to their clinical needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only standard care will be provided to this group. Medications will be prescribed and referral to community nurse, social worker and psychologist will be made by the doctors according to their need.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia (CBT-I)</intervention_name>
    <description>This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.</description>
    <arm_group_label>CBT-I plus standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents&#xD;
&#xD;
          -  Aged ≥ 18 years&#xD;
&#xD;
          -  Able to to communicate in Cantonese and write in Chinese&#xD;
&#xD;
          -  First episode of depressive or bipolar disorders according to the DSM-5 diagnostic&#xD;
             criteria&#xD;
&#xD;
          -  Having received psychiatric treatment for less than 12 months&#xD;
&#xD;
          -  Meeting the DSM-5 diagnostic criteria for insomnia disorder for at least 1 month,&#xD;
             instead of at least 3 months, as in criterion D.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairments and psychotic symptoms, based on a Mini-mental State&#xD;
             Examination score of 23 or below and the Positive and Negative Syndrome Scale items on&#xD;
             delusions, conceptual disorganization, and hallucinatory behavior at moderate severity&#xD;
             or above&#xD;
&#xD;
          -  A diagnosis of schizophrenia, delusional disorder, neurocognitive disorders, or&#xD;
             learning disability&#xD;
&#xD;
          -  Having a highly unstable medical or psychiatric condition (including strong suicidal&#xD;
             risk) that requires hospitalization&#xD;
&#xD;
          -  Having an untreated sleep disorder, including narcolepsy, obstructive sleep apnea, and&#xD;
             periodic leg movement disorder&#xD;
&#xD;
          -  Past or current treatment with CBT-I&#xD;
&#xD;
          -  Having a fear of speaking in a group setting or refusal to give informed consent&#xD;
&#xD;
          -  Refuse to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Chung Ka-Fai</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cognitive-behavioral therapy for insomnia</keyword>
  <keyword>insomnia</keyword>
  <keyword>mood disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000894
org study id: UW 16-057
nct id: NCT03000894
lead sponsor: 
collaborator: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: The number and type of relapses
time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: The number of clinic visits and hospitalizations
time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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)
measure: Prescribed medication burden
time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
time frame: Immediate post-treatment (around 8-week post-baseline)
measure: Subjects' adherence to CBT-I measured by treatment adherence scale
time frame: Immediate post-treatment (around 8-week post-baseline)
arm group label: CBT-I plus standard care
arm group type: Experimental
description: The group CBT-I will receive both CBT-I and standard care. CBT-I covers sleep-wake cycle as well as sleep hygiene education, activity scheduling, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Standard care will include those treatments provided by the psychiatrists according to their clinical needs.
arm group label: Standard care
arm group type: No Intervention
description: Only standard care will be provided to this group. Medications will be prescribed and referral to community nurse, social worker and psychologist will be made by the doctors according to their need.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia (CBT-I)
description: This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.
arm group label: CBT-I plus standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Chung Ka-Fai
investigator title: Associate Professor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Mental Disorders
mesh term: Mood Disorders