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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Insomnia
Depression

Treatments

Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D)
Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I)

Study type

Interventional

Funder types

Other

Identifiers

NCT03438331
27613017

Details and patient eligibility

About

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.

Enrollment

133 patients

Sex

All

Ages

12 to 24 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chinese aged 12-24 years old;
  • Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
  • Being able to comply with the study protocol;
  • 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

  • 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;
  • Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
  • 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;
  • Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
  • In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
  • Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
  • Initiation of or change in antidepressant medication within past 2 months;
  • Having been or is currently receiving any structured psychotherapy;
  • With hearing or speech deficit;
  • Night shift worker.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

133 participants in 3 patient groups

CBT-I
Experimental group
Treatment:
Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I)
CBT-D
Active Comparator group
Treatment:
Behavioral: Cognitive Behavioural Therapy for Depression (CBT-D)
Waiting-list control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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