a pilot rct on the efficacy of trans-c intervention on anxiety symptoms

Conditions: Anxiety

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.


Eligibility criteria:
inclusion criteria: 1. hong kong residents aged ≥ 18 years; 2. cantonese language fluency; 3. score on gad-7 is 10 or above (johnson et al., 2019, spitzer et al., 2006); 4. at least 1 sleep or circadian problem according to the sleep and circadian problem checklist, including time needed to fall asleep more than 30 minutes for more than 3 nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per night per 24 hour period for at least 3 nights per week, variability in the sleep-wake schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least 3 nights per week; 5. adequate opportunity and circumstances for sleep to occur; and willing to give informed consent and comply with the trial protocol. exclusion criteria: 1. presence of other psychiatric disorders as defined by the dsm-v diagnostic criteria; 2. have suicidal ideation based on beck depression inventory (bdi-ii) item 9 score ≥ 2; 3. major medical or neurocognitive disorders that make participation infeasible; 4. untreated sleep disorders based on sleep-50 (≥ 7 on narcolepsy; ≥ 15 on osa; ≥ 7 on rls/plmd); 5. past or current involvement in a psychological treatment programme for anxiety disorder and/or sleep problems; 6. shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns; 7. hospitalization; 8. a change in psychotropic drugs within 2 weeks before baseline assessment

Keywords: anxiety insomnia transdiagnostic sleep and circadian treatment randomised controlled trial trans-c transdiagnostic sleep intervention