A Pilot RCT on the Efficacy of TranS-C Intervention on Anxiety Symptoms
NCT ID: NCT05453981
Last Updated: 2022-08-23
Study Results
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Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-09-01
2023-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TranS-C group
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.
Transdiagnostic Sleep and Circadian Intervention
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).
CAU group
The CAU group will receive care as usual.
No interventions assigned to this group
Interventions
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Transdiagnostic Sleep and Circadian Intervention
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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Assistant Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
Harvey AG, Dong L, Hein K, Yu SH, Martinez AJ, Gumport NB, Smith FL, Chapman A, Lisman M, Mirzadegan IA, Mullin AC, Fine E, Dolsen EA, Gasperetti CE, Bukosky J, Alvarado-Martinez CG, Kilbourne AM, Rabe-Hesketh S, Buysse DJ. A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. J Consult Clin Psychol. 2021 Jun;89(6):537-550. doi: 10.1037/ccp0000650.
Glynn LG, Valderas JM, Healy P, Burke E, Newell J, Gillespie P, Murphy AW. The prevalence of multimorbidity in primary care and its effect on health care utilization and cost. Fam Pract. 2011 Oct;28(5):516-23. doi: 10.1093/fampra/cmr013. Epub 2011 Mar 24.
Lam CL, Brazier J, McGhee SM. Valuation of the SF-6D Health States Is Feasible, Acceptable, Reliable, and Valid in a Chinese Population. Value Health. 2008 Mar-Apr;11(2):295-303. doi: 10.1111/j.1524-4733.2007.00233.x.
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Other Identifiers
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PSY024
Identifier Type: -
Identifier Source: org_study_id
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