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

NCT05453981 | Unknown

• 1 other identifier: PSY024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Anxiety; Insomnia; Transdiagnostic Sleep and Circadian Treatment; randomised controlled trial; TranS-C; Transdiagnostic Sleep intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in the Hospital Anxiety and Depression Scale (HADS)

  baseline, immediate post-treatment and 12-week follow-up

• Change in the 7-day Consensus Sleep Diary

  baseline, immediate post-treatment and 12-week follow-up

• Change in the Insomnia Severity Index (ISI)

  baseline, immediate post-treatment and 12-week follow-up

• Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version

  baseline, immediate post-treatment and 12-week follow-up

• Change in the Multidimensional Fatigue Inventory (MFI)

  baseline, immediate post-treatment and 12-week follow-up

Study Arms (2)

TranS-C group

EXPERIMENTAL

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

CAU group

NO INTERVENTION

The CAU group will receive care as usual.

Interventions

Transdiagnostic Sleep and Circadian Intervention BEHAVIORAL

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).

TranS-C group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, HKSAR, Hong Kong

Location

Related Publications (9)

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  PMID: 11438246 BACKGROUND

• 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.

  PMID: 22294820 BACKGROUND

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  PMID: 11132119 BACKGROUND

• 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.

  PMID: 34264701 BACKGROUND

• 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.

  PMID: 21436204 BACKGROUND

• 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.

  PMID: 18380642 BACKGROUND

• 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.

  PMID: 7636775 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Eugenia Kam

CONTACT

3943 6575; pmhlab@cuhk.edu.hk

Vivian Cheung

CONTACT

3943 6575; pmhlab@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 12, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)