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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05453981

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Transdiagnostic Sleep and Circadian Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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).
No Intervention: CAU group The CAU group will receive care as usual.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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).

No Intervention: CAU group

The CAU group will receive care as usual.

Outcome Measures

Primary Outcome Measures

Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7) [baseline, immediate post-treatment and 12-week follow-up]
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).

Secondary Outcome Measures

Change in the Hospital Anxiety and Depression Scale (HADS) [baseline, immediate post-treatment and 12-week follow-up]
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.
Change in the 7-day Consensus Sleep Diary [baseline, immediate post-treatment and 12-week follow-up]
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.
Change in the Insomnia Severity Index (ISI) [baseline, immediate post-treatment and 12-week follow-up]
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.
Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version [baseline, immediate post-treatment and 12-week follow-up]
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).
Change in the Multidimensional Fatigue Inventory (MFI) [baseline, immediate post-treatment and 12-week follow-up]
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.
Change in the Credibility-Expectancy Questionnaire (CEQ) [baseline, immediate post-treatment and 12-week follow-up]
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Change in the Insomnia Treatment Acceptability Scale (ITAS) [baseline, immediate post-treatment and 12-week follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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