An interventional study of Transdiagnostic Sleep and Circadian Intervention in Anxiety, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
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
The CAU group will receive care as usual.
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).
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).
Time frame: baseline, immediate post-treatment and 12-week follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, immediate post-treatment and 12-week follow-up
Plan to share: No
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Chinese University of Hong Kong