Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT

Insomnia Clinical Trial

— CBTI  

Official title:

Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653155
• Other study ID #: CREC 2019.126
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Hospital Authority, Hong Kong
• Contact: Amy Kwok, PhD
• Phone: +852 39197716
• Email: kwokpl[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Insomnia is a common mental problem, where people experienced difficulty falling asleep, problem maintaining asleep and early morning awakening. It is highly prevalent world-wide and in Hong Kong, causing significant suffering and distress. While evidence based intervention exists, e.g. cognitive-behavioural therapy (CBT), there will not enough therapists to meet treatment demand. A more efficient delivery of treatment, e.g. internet based therapy is called for that can delivery treatment more cost efficiently by requiring lesser therapist time.

Objective: This study aims at evaluating the effectiveness of CBTi (Gp) on treating Chinese insomniac adults in Hong Kong. There has been criticism that most clinical trials have been conducted with Caucasians in Western countries and little has been done with ethnic minorities, including Asians in these countries, not to mention Asians in Asian countries, e.g., Chinese in Hong Kong.

Design: A two-arm parallel-group randomised controlled trial, comparing the treatment and waitlist group

Method: A CBTi protocol would be developed. Approximately 60 Chinese adults with insomnia will be recruited in Hong Kong and randomised into one of the two groups (treatment vs. waitlist). The treatment last for 6 weeks, plus a 3-month follow-up period. The primary outcome measure will be Insomnia Severity Index (ISI).

Description:

Insomnia is characterized by difficulty in initiating sleep, difficulty in maintaining sleep, early morning awakening and non-restorative sleep, which should be relatively frequent (>/= 3 times/ week), persistent (>/= 2-4 weeks) and severe enough to affect daytime functioning. It is among the most common mental disorders. Epidemiological surveys in Western countries found a high prevalence of insomnia syndrome (9.2-13%) and insomnia symptoms (11.4% to 38%). In Hong Kong, a prevalence of 11.9% was reported for community adults. Given such high prevalence, insomnia is evidently one major health concern across diverse communities, including Hong Kong. Furthermore, the disorder runs a chronic and debilitating course if untreated.

Interrelationships between insomnia and mental health are now well established in the epidemiological literature, with insomnia shown to be frequently comorbid with mental health concerns, such as depression or anxiety and risk of suicide. Insomnia symptoms have repeatedly been shown to increase the risk of subsequent depression. Also, it is shown that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with depression and comorbid insomnia in terms of alleviating both depression and insomnia. It is clear that insomnia is not only a disorder of high personal suffering, but is also associated with high and recurring societal costs. These facts strongly argue for the need of effective treatments to relieve personal suffering, caring burdens, and societal economic costs.

Fortunately, there are effective treatments available for insomnia, particularly cognitive-behavioural therapy (CBT). In a number of meta-analysis of insomnia treatments, CBT is effective and consistently performs better than placebo and other control conditions in improving nighttime insomnia symptoms, including sleep latency, total sleep time, wake after sleep onset, and insomnia symptoms. CBT for insomnia (CBTi) packages include stimulus control, relaxation, sleep restriction and their combination meet APA criteria for empirically validated treatment for insomnia based on the strength of results from a number of empirical studies.

Unfortunately, while effective psychological treatments exist, there is only limited manpower to provide the intervention. Western studies showed that 15-25% of children and adults were suffering from mental health disorders, but only 20-30% of them had access to treatment. Locally in Hong Kong, we are facing an almost identical situation. About 15% of children and adults suffered from mental health disorders, but again only 15-30% of them had access to mental health services. Obviously, a shortage of mental health professionals such as psychiatrists or clinical psychologists is a worldwide phenomenon. In Hong Kong, our situation regarding the availability of clinical psychologists (CPs) in providing psychological treatment is even worse. We have a ratio of approximately 1 CP to 18,000 in the Hong Kong population, far below the ratio of 1 in 3,500 in the USA.

Most governments, including those of richer countries like USA, will admit that they will never have the resources to increase the number of mental health professionals like psychiatrists and CPs to meet the societal demand. Instead, a more viable solution is to look for greater cost-efficiency in delivering services. Recent meta-analyses find the effectiveness of group psychological treatment (mostly CBT) for insomnia as largely comparable to that of traditional one on one therapy. Group therapy is thus advocated as a less-intensive, cost-effective way to offer evidence-based treatment.

Based on Morin, we developed a treatment protocol for CBTi, incorporating both education and individualized feedback. The protocol implements all of the key procedures in one-on-one CBTi such as sleep restriction, stimulus control, managing dysfunctional beliefs about sleep, behavioural experiments, increasing energizing behaviours, all of which target the maintaining factors of insomnia. Patients would be assigned a therapist to follow up on them via either brief (5-10 minutes) telephone calls. Compared to traditional face to face CBTi, the protocol requires 32% of the therapist's time of the latter, i.e., a 68% drop in the therapist's time.

There is a paucity of study in the effectiveness of cognitive behaviour therapy for insomnia in Hong Kong Chinese, let alone CBTi in group. This proposal aims at developing a CBTi protocol for treatment of insomnia in Hong Kong to increase the access of evidence-based treatment to local Chinese insomnia adults. This involves protocol development, test-run and a randomized controlled trial (RCT) with a waitlist control group and a short-term follow-up of three months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Insomnia

• Chinese aged 18-65 years old

• Chinese reading and writing proficiency of primary school

• Ability to give consent

• Accept randomization

Exclusion Criteria:

• substance abuse or dependence

• manic or hypomanic episode

• schizophrenia

• personality disorders

• posttraumatic stress disorder (PTSD)

• mental retardation

• organic mental disorder

• Suicidal risk or a suicidal attempt in the past three months

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive behavioural therapy for insomnia
Cognitive behavioural therapy for insomnia

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Psychology, New Territories East Cluster, Hospital Authority	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Symptom Inventory (ISI) (Bastien et al, 2001)	A 7-item self-report questionnaire assessing the nature, severity and the impact of insomnia. Insomnia Symptom Inventory is the primary outcome measure. All items are assessed on a 5-point scale (0-4), with its total score ranging between 0 to 28. Higher score representing worse insomnia symptoms.	Change from baseline Insomnia Symptom Inventory at 3 months
Secondary	Change in Dysfunctional Beliefs about Sleep Scale (DBAS) (Morin et al, 2007)	A self-report questionnaire for evaluation of cognition, behaviours and attitudes related to insomnia. All items are assessed on a 5-point scale (0-4). Its total score ranged between 0 to 112, with higher score representing more dysfunctional beliefs about sleep.	Change from baseline Dysfunctional Beliefs about Sleep Scale at 3 months
Secondary	Change in Patient Health Questionnaire 9 (PHQ-9) (Kroenke & Spitzer, 2002)	A 9-item self-report questionnaires for evaluation of depression. All items are assessed on a 4-point scale (0-3). Its total score ranged between 0 to 27, with higher score representing more severe depressive symptoms.	Change from baseline Patient Health Questionnaire 9 (PHQ-9) at 3 months
Secondary	Change in Generalized Anxiety Disorder-7 item (GAD-7) Questionnaire (Spitzer et al, 2006)	A 7-item self-report questionnaires for evaluation of general anxiety. All items are assessed on a 4-point scale (0-3), with its total score ranging between 0 to 21. Higher score representing increased anxiety symptoms.	Change from baseline Generalized Anxiety Disorder-7 item (GAD-7) Questionnaire at 3 months
Secondary	Change in Work and Social Adjustment Scale (WSAS) (Mundt et al, 2002)	A 5-item simple self-report measure of impairment in functioning. All items are assessed on a 9-point scale (0-8), with its total score ranging between 0 to 40. Higher score representing greater impairment in functioning	Change from baseline Work and Social Adjustment Scale at 3 months