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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394753
• Other study ID #: EA210411
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 2023

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: Shirley X Li, PhD
• Phone: 39177035
• Email: shirley.li[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression, Anxiety
• Insomnia
• Quality of Life

Intervention

Behavioral:
• Unified Protocol for mood disorders
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.

Locations

Country	Name	City	State
Hong Kong	Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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