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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Transdiagnostic Sleep and Circadian Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hong Kong residents aged ≥ 18 years; Cantonese language fluency; Score on GAD-7 is 10 or above (Johnson et al., 2019, Spitzer et al., 2006); 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; Adequate opportunity and circumstances for sleep to occur; and willing to give informed consent and comply with the trial protocol. Exclusion Criteria: Presence of other psychiatric disorders as defined by the DSM-V diagnostic criteria; Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2; Major medical or neurocognitive disorders that make participation infeasible; Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD); Past or current involvement in a psychological treatment programme for anxiety disorder and/or sleep problems; Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns; Hospitalization; A change in psychotropic drugs within 2 weeks before baseline assessment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TranS-C group<br>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. | Behavioral: Transdiagnostic Sleep and Circadian Intervention<br>* 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).<br>|
| No Intervention: CAU group<br>The CAU group will receive care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline, immediate post-treatment and 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hospital Anxiety and Depression Scale (HADS) | A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purposes and not meant to be a diagnostic tool. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately. | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the 7-day Consensus Sleep Diary | The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min); sleep efficiency (SE; calculated as TST/TIB * 100%), etc. | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the Insomnia Severity Index (ISI) | ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem. | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version | A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state). | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the Multidimensional Fatigue Inventory (MFI) | A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue. | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the Credibility-Expectancy Questionnaire (CEQ) | The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. | baseline, immediate post-treatment and 12-week follow-up | 
| Change in the Insomnia Treatment Acceptability Scale (ITAS) | The 8-item Insomnia Treatment Acceptability Scale (ITAS) may examine treatment acceptability. Respondents would score each item from 0 (not at all acceptable) to 4 (very acceptable) to rate if the rationale made sense, how acceptable the treatment was for them, suitability for their sleep problem, and expected effectiveness for their sleep problem. | baseline, immediate post-treatment and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdiagnostic Sleep and Circadian Treatment, randomised controlled trial, TranS-C, Transdiagnostic Sleep intervention, Anxiety, Insomnia