Quality of LifeNCT05394753
The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
A study testing Unified Protocol for mood disorders in people with Quality of Life and Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Insomnia, Depression, Anxiety
- What is being tested?
- Unified Protocol for mood disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2021to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
- currently receiving taking other psychosocial interventions
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley X Li, DClinPsy, 39177035, shirley.li@hku.hk
About this study
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.
- Conditions
- Quality of Life, Insomnia, Depression, Anxiety
- Being tested
- Unified Protocol for mood disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for mood disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol | Experimental | 8-session group-based intervention Receives: Behavioral: Unified Protocol for mood disorders |
| Wait-list control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive affect
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Measured: 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)
Measured: 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.
Measured: week 1, week 5, week 9, 12 weeks after completion of intervention
Secondary outcomes (26)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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, %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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, %
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week 1, week 5, week 9, 12 weeks after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Nov 2021
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394753
- Sponsor's protocol ID
- EA210411
- Status last verified
- May 2022
- First submitted
- 14 Feb 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
- ClinicalTrials.gov ID
- NCT05394753
- Acronym / sponsor ID
- EA210411
- Conditions
- Quality of Life, Insomnia, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol | Experimental | Behavioral: Unified Protocol for mood disorders8-session group-based intervention |
| Wait-list control | No intervention | –Participants in the wait-list control group will receive the same program, two months after their counterparts in the experimental group completed the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
- currently receiving taking other psychosocial interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for mood disordersThe 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. | Behavioural | Unified Protocol |
Primary outcome
Change in Positive affect
Time frame: 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
Time frame: 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
Time frame: 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.
26 secondary outcomes
Change of Sleep Diary Measure - Time in Bed (TIB)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Total Sleep Time (TST)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Sleep Onset Latency (SOL)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of Sleep Diary Measure - Sleep Efficiency (SE)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Time in Bed (TIB)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Total Sleep Time (TST)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of objective sleep measure (sleep onset latency, SOL)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Objective Sleep Measures - Sleep Efficiency (SE)
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in General Health
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change in Stress
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change in Compassion
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Self-compassion
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Common humanity
Time frame: week 1, week 9, 12weeks after completion of intervention
Change in Mindfulness
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Decentering
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change in Emotion Regulation
Time frame: week 1, week 5, week 9,12 weeks after completion of intervention
Change of clinically depressive symptoms
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of clinically anxiety symptoms
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of subjective mental well-being
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Change of pre-sleep arousal
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of sleep reactivity
Time frame: week 1, week 9, 12 weeks after completion of intervention
Change of quality of life
Time frame: week 1, week 5, week 9, 12weeks after completion of intervention
TMSS-repair
Time frame: week 1, week 9, 12 weeks after completion of intervention
RRS
Time frame: week 1, week 5, week 9, 12 weeks after completion of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for mood disorders in people with Quality of Life and Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley X Li, PhD (39177035, shirley.li@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive affect (time frame: week 1, week 5, week 9, 12 weeks after completion of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.