The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
- Conditions
- Quality of LifeInsomniaDepression, Anxiety
- Interventions
- Behavioral: Unified Protocol for mood disorders
- Registration Number
- NCT05394753
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Working in local schools or education institutions
- aged 18 or above
- no severe or unstable mental health conditions at recruitment
- no extensive prior training/practice with mindfulness
- psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
- currently receiving taking other psychosocial interventions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unified Protocol Unified Protocol for mood disorders 8-session group-based intervention
- Primary Outcome Measures
Name Time Method Change in Positive affect week 1, week 5, week 9, 12 weeks after completion of intervention Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change in Negative affect week 1, week 5, week 9, 12 weeks after completion of intervention Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of insomnia symptoms week 1, week 5, week 9, 12 weeks after completion of intervention 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.
- Secondary Outcome Measures
Name Time Method Change of Sleep Diary Measure - Time in Bed (TIB) week 1, week 9, 12 weeks after completion of intervention Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours
Change of Sleep Diary Measure - Wake After Sleep Onset (WASO) week 1, week 9, 12 weeks after completion of intervention Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins
Change in Mindfulness week 1, week 9, 12 weeks after completion of intervention Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of clinically anxiety symptoms week 1, week 5, week 9, 12 weeks after completion of intervention 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.
Change in Objective Sleep Measures - Sleep Efficiency (SE) week 1, week 9, 12 weeks after completion of intervention 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, %
Change in General Health week 1, week 5, week 9, 12 weeks after completion of intervention General Health Questionnaire (GHQ), 12 items, 4-point Likert scale ranging from 1 (never) to 5 (always)
Change in Common humanity week 1, week 9, 12weeks after completion of intervention Common Humanity scale, 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change in Decentering week 1, week 9, 12 weeks after completion of intervention Non Reactivity Subscale of Chinese Five Facet Mindfulness Questionnaire (FFMQ-C), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of subjective mental well-being week 1, week 5, week 9, 12 weeks after completion of intervention 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.
Change of quality of life week 1, week 5, week 9, 12weeks after completion of intervention WHOQOL-BREF, 26 items, 5-point Likert scale ranging from 1 (never/very bad/strongly disagree) to 5 (always/very good/strongly agree)
Change of Sleep Diary Measure - Sleep Efficiency (SE) week 1, week 9, 12 weeks after completion of intervention 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, %
Change in Objective Sleep Measures - Total Sleep Time (TST) week 1, week 9, 12 weeks after completion of intervention Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours
Change in Self-compassion week 1, week 9, 12 weeks after completion of intervention Self-compassion scale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
TMSS-repair week 1, week 9, 12 weeks after completion of intervention Trait Meta-Mood Scale repair subscale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
RRS week 1, week 5, week 9, 12 weeks after completion of intervention Ruminative responsive scale, 22 items, 4-point Likert scale ranging from 1 (almost never) to 4 (almost always)
Change in Emotion Regulation week 1, week 5, week 9,12 weeks after completion of intervention Reappraisal subscale of Emotion Regulation Questionnaire (ERQ), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of pre-sleep arousal week 1, week 9, 12 weeks after completion of intervention 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.
Change of sleep reactivity week 1, week 9, 12 weeks after completion of intervention 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.
Change of Sleep Diary Measure - Total Sleep Time (TST) week 1, week 9, 12 weeks after completion of intervention Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours
Change of Sleep Diary Measure - Sleep Onset Latency (SOL) week 1, week 9, 12 weeks after completion of intervention Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins
Change in Objective Sleep Measures - Time in Bed (TIB) week 1, week 9, 12 weeks after completion of intervention Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours
Change of objective sleep measure (sleep onset latency, SOL) week 1, week 9, 12 weeks after completion of intervention Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO) week 1, week 9, 12 weeks after completion of intervention Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins
Change in Stress week 1, week 5, week 9, 12 weeks after completion of intervention Perceived Stress Scale (PSS), 10 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change in Compassion week 1, week 9, 12 weeks after completion of intervention Compassion scale, 6 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of clinically depressive symptoms week 1, week 5, week 9, 12 weeks after completion of intervention 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.
Trial Locations
- Locations (1)
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
🇭🇰Hong Kong, Hong Kong