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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Anxiety

Treatments: Behavioral: Transdiagnostic Sleep and Circadian Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05453981

PSY024

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

TranS-C group

Experimental group

Description:

The TranS-C group will receive weekly 2 hour TranS-C group intervention delivered by 2 clinical psychology trainees for 6 weeks, contents being core modules from Harvey et al. (2016)'s protocol.

Treatment:

Behavioral: Transdiagnostic Sleep and Circadian Intervention

CAU group

No Intervention group

Description:

The CAU group will receive care as usual.