The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health

Conditions
-----------------
Quality of Life, Insomnia, Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Unified Protocol for mood disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk currently receiving taking other psychosocial interventions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified Protocol<br>8-session group-based intervention | Behavioral: Unified Protocol for mood disorders<br>* 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.<br>|
| No Intervention: Wait-list control<br>Participants in the wait-list control group will receive the same program, two months after their counterparts in the experimental group completed the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive affect | Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always) | 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) | 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. | week 1, week 5, week 9, 12 weeks after completion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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, % | 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 | 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 | 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 | 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 | 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, % | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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) | 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) | 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) | week 1, week 5, week 9, 12 weeks after completion of intervention |