NCT05453981

A Pilot RCT on the Efficacy of TranS-C Intervention on Anxiety Symptoms

A Pilot Randomized Controlled Trial on the Efficacy of Transdiagnostic Sleep and Circadian (TranS-C) Intervention on Anxiety Symptoms

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will examine whether the Transdiagnostic Sleep and Circadian Intervention (TranS-C; Harvey \& Buysse, 2017) can improve sleep and circadian functioning and reduce disorder-focused symptoms in patients with anxiety symptoms. Sleep disturbance is highly comorbid with GAD (Dolsen et al., 2014). TranS-C, targeting common sleep disturbances in disorders, has improved disorder-focused symptoms and sleep and circadian functioning in patients with Severe mental illness (SMI). Nonetheless, no study examined TranS-C's efficacy on GAD patients specifically. Hence, this study will be a pilot study that examines the efficacy of TranS-C on people with anxiety symptoms by comparing with a care-as-usual control group (CAU). Around 80 Hong Kong residents aged 18 or above, with a GAD-7 score 10 or above and at least 1 sleep or circadian problem will be recruited. Eligible participants will be randomized to the TranS-C group or CAU group in a 1:1 ratio. The TranS-C group will receive 2-hour group-based TranS-C intervention delivered by clinical psychology trainees for 6 weeks under the supervision of a clinical psychologist. Both groups will complete a set of questionnaires at baseline, immediate post-treatment and 12-week follow-up. They will also complete sleep diaries throughout as homework. The outcome measures include mood, sleep, quality of life etc. This study will test whether theTranS-C intervention apparoach can be considered as a treatment for people with anxiety symptoms and sleep problems.

Conditions

• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Transdiagnostic Sleep and Circadian Intervention	Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. It targets common sleep disturbances in disorders and has improved disorder-focused symptoms and sleep and circadian functioning in patients with Severe mental illness (SMI).

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-07-12
• Last updated: 2022-08-23

Locations

1 site across 1 country: Hong Kong