Low-intensity Cognitive-behavioural Therapy for Insomnia

NCT03736694 | Completed

• 1 other identifier: UW 18-396
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. Therefore, it is significant to conduct this study. A total of 210 participants aged \> 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.

Conditions

Insomnia

Keywords

Insomnia; Cognitive behavioural therapy for insomnia; Sleep hygiene education

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia severity

  To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy \& Swanson, et al, 2014; Wong, Zhang \& Li, et al, 2017).

  Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

Secondary Outcomes (2)

• Change in Symptoms of Mood disorders

  Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

• Change in Quality of life

  Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)

Study Arms (3)

CBTI Workshop

EXPERIMENTAL

The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, \& Swanson, et al, 2014; Morin, Savard, Ouellet, \& Daley, 2003). One workshop has the capacity of 30 participants.

Behavioral: Cognitive behavioural therapy for insomnia

Self-Help CBTI

EXPERIMENTAL

The second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1.

Behavioral: Cognitive behavioural therapy for insomnia

SHE Workshop

ACTIVE COMPARATOR

The control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants.

Behavioral: Sleep hygiene education

Interventions

Cognitive behavioural therapy for insomnia BEHAVIORAL

CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, \& Daley, 2003). It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, \& Denberg, 2016). CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, \& Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, \& Brown, 2012). Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, \& Meijer, 2015).

CBTI Workshop; Self-Help CBTI

Sleep hygiene education BEHAVIORAL

SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, \& Daley, 2003).

SHE Workshop

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents
• Aged 16 or above
• Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
• Score at least 10 points in Insomnia Severity Index
• Able to read and understand Cantonese
• Have Internet access

You may not qualify if:

• Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
• Currently receiving CBTI or SHE
• Work on irregular rotational shift

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator. The participants are required to fill in online questionnaires themselves to prevent possible biases during outcome assessments. The participants will be labelled by numbers without any personal information or intervention group allocated during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: A prospective randomized controlled trial (RCT) will be performed to compare the effectiveness of the 3 types of therapies. After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator. The first intervention group (Group 1) will attend one half-day cognitive behavioural therapy for insomnia (CBTI) workshop in the community setting. The second intervention group (Group 2) will receive self-help CBTI. The control group (Group 3) will receive sleep hygiene education (SHE).

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

HK (1)