Clinical trial NCT05394753: The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
Official title: The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Insomnia
Depression, Anxiety
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Positive affect
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change in Negative affect
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change of insomnia symptoms
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
Secondary outcomes:
measure: Change of Sleep Diary Measure - Time in Bed (TIB)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of Sleep Diary Measure - Total Sleep Time (TST)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of Sleep Diary Measure - Sleep Efficiency (SE)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Objective Sleep Measures - Time in Bed (TIB)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Objective Sleep Measures - Total Sleep Time (TST)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of objective sleep measure (sleep onset latency, SOL)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Objective Sleep Measures - Sleep Efficiency (SE)
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in General Health
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change in Stress
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change in Compassion
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Self-compassion
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Common humanity
timeFrame: week 1, week 9, 12weeks after completion of intervention
measure: Change in Mindfulness
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Decentering
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change in Emotion Regulation
timeFrame: week 1, week 5, week 9,12 weeks after completion of intervention
measure: Change of clinically depressive symptoms
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change of clinically anxiety symptoms
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change of subjective mental well-being
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
measure: Change of pre-sleep arousal
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of sleep reactivity
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: Change of quality of life
timeFrame: week 1, week 5, week 9, 12weeks after completion of intervention
measure: TMSS-repair
timeFrame: week 1, week 9, 12 weeks after completion of intervention
measure: RRS
timeFrame: week 1, week 5, week 9, 12 weeks after completion of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
References: