Clinical trial NCT05453981: A Pilot RCT on the Efficacy of TranS-C Intervention on Anxiety Symptoms
Official title: A Pilot Randomized Controlled Trial on the Efficacy of Transdiagnostic Sleep and Circadian (TranS-C) Intervention on Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Insomnia
Transdiagnostic Sleep and Circadian Treatment
randomised controlled trial
TranS-C
Transdiagnostic Sleep intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
Secondary outcomes:
measure: Change in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the 7-day Consensus Sleep Diary
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the Multidimensional Fatigue Inventory (MFI)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
measure: Change in the Insomnia Treatment Acceptability Scale (ITAS)
timeFrame: baseline, immediate post-treatment and 12-week follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
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