Digital Cognitive Behavioral Therapy for Insomnia in China

Peking University

Status: Completed

Conditions: Primary Insomnia

Treatments: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Sleep Hygiene Education (SHE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05416346

dCBT-i-Chinese

Details and patient eligibility

About

Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• were aged 18 or older;
• had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
• had stable access to the internet via a smartphone.

Exclusion criteria

• additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
• psychosis or mania;
• serious physical health concerns necessitating surgery or with prognosis <6 months;
• undergoing medical or psychological treatment for insomnia with a health professional;
• habitual night shift, evening, or rotating shift-workers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

dCBT-i

Experimental group

Description:

The dCBT-i group received the whole intervention

Treatment:

Behavioral: Digital Cognitive Behavioral Therapy

Sleep Hygiene Education (SHE)

Active Comparator group

Description:

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Treatment:

Behavioral: Digital Cognitive Behavioral Therapy

Behavioral: Sleep Hygiene Education (SHE)