Internet-Based Cognitive-Behavioral Therapy for Insomnia

Insomnia Clinical Trial

Official title:

Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719120
• Other study ID #: CBTI-001
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: May 12, 2016
• Start date: August 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: May 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Cognitive-Behavioral Therapy
CBT 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.

Locations

Country	Name	City	State
Hong Kong	the University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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 Oct 23;63C:147-156. doi: 10.1016/j.brat.2014.10.002. [Epub ah — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment.	No
Secondary	Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment.	No
Secondary	Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment.	No
Secondary	Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment	No
Secondary	Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment.	No
Secondary	Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, 1-week, 5-week, and 12-week posttreatment.	No
Secondary	Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale		Baseline and 1-week posttreatment	No
Secondary	Subjects' adherence to the treatment measured by Treatment adherence rating scale		1-week posttreatment	No
Secondary	Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale		Treatment Week 2-6	No
Secondary	Potential side effects associated with each component of CBT measured by Symptom checklist		Treatment Week 2-6 and 1-week posttreatment	Yes
Secondary	Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire	12-week posttreatment is only for within-group comparison in treatment groups	Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.	No