Health TrialsbyHealthPanel

CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety

ConditionsInsomniaAnxietyYouth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorChinese University of Hong Kong

About this trial

Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBT-I

    Behavioral

    The CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training.

  • CBT-I combined ACT

    Behavioral

    In addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CBT-IActive comparator 1 intervention
Group B: CBT-I combined ACTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Severity of anxiety symptoms and severity

General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity.

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up
2

Severity of anxiety symptoms

Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms.

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up
3

Clinician-rated severity of anxiety symptoms

Hamilton Anxiety Rating Scale (HAM-A) will be used to assess anxiety symptoms.

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up

Secondary outcomes

1

Severity of insomnia symptoms

Insomnia Severity Index (ISI) will be used to measure the severity of insomnia symptoms.

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up
2

Sleep-wake pattern

Youths will be asked to keep a sleep diary to chart their daily sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up
3

Daytime sleepiness

Pediatric Daytime Sleepiness Scale (PDSS) will be used to assess adolescents' daytime sleepiness.

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up
4

Anxiety trait

The State-Trait Anxiety Inventory (STAI) will be used to measure anxiety trait

Time frame
Baseline, Postintervention (6 weeks), and 3-month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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