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Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438331
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
Chinese University of Hong Kong
University of Oxford
Information provided by (Responsible Party):
Dr. Shirley Xin Li, The University of Hong Kong

Brief Summary:
Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in adolescents with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. This project will involve a randomised controlled trial proposed to examine whether insomnia treatment confers additional benefit to depression treatment in adolescents with comorbid depression and insomnia, for improving sleep and depressive symptoms, and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term. Eligible adolescent participants will be randomised to either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or 8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control condition. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at posttreatment one-month and six-month.

Condition or disease Intervention/treatment Phase
Insomnia Depression Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth: a Randomised, Assessor Blind, Parallel Group Trial
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT-I Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I)
The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.

Active Comparator: CBT-D Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D)
The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-D delivered within a 10-week window. The main treatment elements of CBT-D include: psycho-education about depression, self-monitoring, behavioural activation, improving social skills, communication skills and problem solving skills, cognitive restructuring (addressing negative and irrational thoughts often associated with depression in adolescents), relaxation techniques, and relapse prevention.

No Intervention: Waiting-list control



Primary Outcome Measures :
  1. Change of depressive symptoms (assessor-rated) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Children's Depression Rating Scale (CDRS-R) is a 17-item rating scale based on a semistructured interview with children. Possible scores range from 17 to 113, with higher scores indicating severer depressive symptoms.

  2. Change of self-report mood symptoms [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores.

  3. Change of insomnia symptoms [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.


Secondary Outcome Measures :
  1. Change of sleep quality [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.

  2. Change of sleep diary measure (time in bed, TIB) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours

  3. Change of sleep diary measure (total sleep time, TST) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours

  4. Change of sleep diary measure (sleep onset latency, SOL) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins

  5. Change of sleep diary measure (wake after sleep onset, WASO) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins

  6. Change of sleep diary measure (sleep efficiency, SE) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %

  7. Change of objective sleep measure (time in bed, TIB) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours

  8. Change of objective sleep measure (total sleep time, TST) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours

  9. Change of objective sleep measure (sleep onset latency, SOL) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins

  10. Change of objective sleep measure (wake after sleep onset, WASO) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins

  11. Change of objective sleep measure (sleep efficiency, SE) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %

  12. Change of daytime sleepiness [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.

  13. Change of daytime fatigue [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.

  14. Change of quality of life [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.

  15. Change of suicidal ideation [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation.

  16. Change of subjective cognitive performance [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Cognitive Failures Questionnaire (CFQ) is a 20-item self-rated scale measuring perceived failures in daily cognitive tasks. Possible total scores range from 0 to 80, with higher scores indicating higher cognitive failures.

  17. Change of objective cognitive performance (visual attention & task switching) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Trail Making Test for assessing visual attention and task switching. In Trail Making Test, longer reaction time indicates lower level of attention.

  18. Change of objective cognitive performance (inhibitory ability) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control.

  19. Change of objective cognitive performance (working memory by digit span) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory.

  20. Change of objective cognitive performance (working memory by N-Back) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance.

  21. Change of objective cognitive performance (episodic memory) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Chinese Auditory Verbal Learning Task for assessing episodic memory, where a higher number of recalled words indicates better episodic memory performance.

  22. Change of objective cognitive performance (problem solving) [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Wisconsin Card Sorting Test for assessing problem solving. In Wisconsin Card Sorting Test, lower executive functioning is indicated by a higher percentage of persistent errors and a higher number of trials taken to complete the first category.

  23. Change of sleep related attention bias [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Sleep-related Dot-Probe Task for assessing sleep-related attention bias. In the Sleep-related Dot-probe Task, a higher attention bias score indicates higher vigilance towards sleep-related stimuli.

  24. Change of risk-taking & decision making [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Balloon Analogue Risk Task for assessing risk-taking and decision-making. In Balloon Analogue Risk Task, a score will be calculated by averaging the number of pumps on unexploded blue balloons, where a higher score indicates more risk-taking and impulsive propensities.

  25. Change of dysfunctional beliefs and attitudes about sleep [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.

  26. Change of sleep hygiene and practice [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.

  27. Change of pre-sleep arousal [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.

  28. Change of overall severity of clinical symptoms [ Time Frame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups ]
    Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of psychopathology, and Clinical Global Improvement Scale (CGI-I) evaluating change from the initiation of treatment. In both cases, the score is given on a seven-point scale, with higher values indicating higher severity of illness and larger improvement respectively.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese aged 12-24 years old;
  2. Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
  3. Being able to comply with the study protocol;
  4. Having a DSM-V diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >=9; AND a DSM-V diagnosis of depressive disorder

Exclusion Criteria:

  1. A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
  2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
  3. Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by DISP;
  4. Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
  5. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
  6. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
  7. Initiation of or change in antidepressant medication within past 2 months;
  8. Having been or is currently receiving any structured psychotherapy;
  9. With hearing or speech deficit;
  10. Night shift worker.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438331


Contacts
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Contact: Shirley Xin Li, PhD, DClinPsy (852)39177035 shirley.li@hku.hk

Locations
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Hong Kong
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Shirley X. Li, PhD, DClinPsy    (852)39177035    shirley.li@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Chinese University of Hong Kong
University of Oxford
Investigators
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Principal Investigator: Shirley Xin Li, PhD,DClinPsy The University of Hong Kong
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Responsible Party: Dr. Shirley Xin Li, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03438331    
Other Study ID Numbers: 27613017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Shirley Xin Li, The University of Hong Kong:
Insomnia
Depression
Adolescents
Youth
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases