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Insomnia | Internet-Based Cognitive-Behavioral Therapy for Insomnia

Insomnia research study

What is the primary objective of this study?

The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.

Who is eligible to participate?

Inclusion Criteria: - Hong Kong residents aged ≥18 years - Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire - Able to read Chinese and type Chinese or English - Have Internet access (PC/ mobile phone), and with an email address - Willing to give informed consent and comply with the trial protocol Exclusion Criteria: - Have suicidal ideas based on self-report

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Cognitive-Behavioral TherapyCBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Self-help CBT with tel. consultationSelf-help CBT with tel. consultation (SHTC)group will receive telephone consultation provided by the investigator in addition to self-help cognitive-behavioral therapy once per week for 6 consecutive weeks.During the consultation, the investigator will answer questions about the treatment content, monitor whether the subjects read the assigned materials and comply with the tasks and procedures, and provide encouragement and support.

Self-help CBTThe subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.

Waiting-list control (WL)Subjects in this group will not receive any kind of treatment during the waiting period. They will receive the treatment identical to the self-help group within 3 months from the baseline.

Study Status

Completed

Start Date: August 2012

Completed Date: May 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.

Secondary Outcome: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Ka-Fai Chung, MBBS

Lead Sponsor: The University of Hong Kong

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01719120

Ho FY, Chung KF, Yeung WF, Ng TH, Cheng SK. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. Behav Res Ther. 2014 Dec;63:147-56. doi: 10.1016/j.brat.2014.10.002. Epub 2014 Oct 23.

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