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

Chinese University of Hong Kong80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anxiety

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)

A brief 7-item instrument for screening for GAD and assessing its severity in clinical practice and research. Anxiety severity is categorized using scores of 5-9 (mild), 10-14 (moderate) and 15 or more (severe).