Low-intensity Cognitive-behavioural Therapy for Insomnia
23 maart 2020 bijgewerkt door: Dr. Chung Ka-Fai, The University of Hong Kong
A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
210
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Hong Kong, Hongkong
- The University of Hong Kong
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CBTI Workshop
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.
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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).
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Experimenteel: Self-Help CBTI
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.
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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).
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Actieve vergelijker: SHE Workshop
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.
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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).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Insomnia severity
Tijdsspanne: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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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).
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Symptoms of Mood disorders
Tijdsspanne: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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Change in Quality of life
Tijdsspanne: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2018
Primaire voltooiing (Werkelijk)
30 juni 2019
Studie voltooiing (Werkelijk)
31 juli 2019
Studieregistratiedata
Eerst ingediend
7 november 2018
Eerst ingediend dat voldeed aan de QC-criteria
8 november 2018
Eerst geplaatst (Werkelijk)
9 november 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
23 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UW 18-396
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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