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

NCT ID: NCT03438331

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2021-03-26

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.

Conditions

Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-I

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy for Insomnia (CBT-I)

Intervention Type: BEHAVIORAL

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.

CBT-D

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioural Therapy for Depression (CBT-D)

Intervention Type: BEHAVIORAL

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.

Waiting-list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Xin Li, PhD,DClinPsy

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

27613017

Identifier Type: -

Identifier Source: org_study_id