Common mental disorders can be disabling and lead to a large burden of disease. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed to address emotional disorders with evidence-based emotional-focused cognitive-behavioural techniques and is efficacious in reducing anxiety symptoms and depressive symptoms in adults. Previous research has demonstrated comparable effect of UP on reducing anxiety symptoms compared with the single-disorder protocol (SDP) for anxiety. Group-based UP was also implemented and tested. Given the fact that working populations are at a high risk of poor mental health, especially in light of the COVID pandemic with new unprecedented work situations and increased uncertainties, the present study aims to investigate the efficacy of Unified protocol on sleep and mental health in high-risk population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
The group-based UP is structured and manualized and consists of 9 1.5 hours weekly sessions (90-min, 18 participants in each group). The group-based UP is a course consisting of components of psycho-education about mood disorders, cognitive and behavioural skills, and relapse prevention and is adapted for the non-clinical population in the current study. The UP will be led and delivered by trained therapists.
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGChange in Positive affect
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change in Negative affect
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of insomnia symptoms
Insomnia symptoms are measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Time in Bed (TIB)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Total Sleep Time (TST)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Sleep Efficiency (SE)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Time in Bed (TIB)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Total Sleep Time (TST)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of objective sleep measure (sleep onset latency, SOL)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in General Health
General Health Questionnaire (GHQ), 12 items, 4-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change in Stress
Perceived Stress Scale (PSS), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change in Compassion
Compassion scale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Self-compassion
Self-compassion scale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Common humanity
Common Humanity scale, 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12weeks after completion of intervention
Change in Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Decentering
Non Reactivity Subscale of Chinese Five Facet Mindfulness Questionnaire (FFMQ-C), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Emotion Regulation
Reappraisal subscale of Emotion Regulation Questionnaire (ERQ), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 5, week 9,12 weeks after completion of intervention
Change of clinically depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) consists of 9 self-report items designed to assess clinically significant depression. Higher scores indicate high level of depression.
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of clinically anxiety symptoms
General Anxiety Disorder-7 (GAD-7) consists of 7 self-report items designed to assess general anxiety symptoms. Higher scores indicate high level of anxiety.
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of subjective mental well-being
The World Health Organisation- Five Well-Being Index (WHO-5) consists of 5 self-report items designed to measure subjective well-being. Higher scores indicate better well-being.
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of pre-sleep arousal
Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of sleep reactivity
Ford Insomnia Response to Stress Test (FIRST) consists of 9 items designed to measure sleep reactivity. Possible scores range from 9 to 36. A higher score indicates higher sleep activity.
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of quality of life
WHOQOL-BREF, 26 items, 5-point Likert scale ranging from 1 (never/very bad/strongly disagree) to 5 (always/very good/strongly agree)
Time frame: week 1, week 5, week 9, 12weeks after completion of intervention
TMSS-repair
Trait Meta-Mood Scale repair subscale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Time frame: week 1, week 9, 12 weeks after completion of intervention
RRS
Ruminative responsive scale, 22 items, 4-point Likert scale ranging from 1 (almost never) to 4 (almost always)
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
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