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

May 23, 2022 updated by: Dr. Shirley Xin Li, The University of Hong Kong
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Unified Protocol
8-session group-based 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.
NO_INTERVENTION: Wait-list control
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
week 1, week 5, week 9, 12 weeks after completion of intervention
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)
week 1, week 5, week 9, 12 weeks after completion of intervention
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.
week 1, week 5, week 9, 12 weeks after completion of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Sleep Diary Measure - Time in Bed (TIB)
Time Frame: 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
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
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)
Time Frame: 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
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
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)
Time Frame: 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, %
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
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)
Time Frame: 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
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
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)
Time Frame: 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
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
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
Time Frame: 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)
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
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
Time Frame: 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)
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
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
Time Frame: 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)
week 1, week 9, 12weeks after completion of intervention
Change in Mindfulness
Time Frame: 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)
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
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
Time Frame: 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)
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
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
Time Frame: 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.
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
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
Time Frame: 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.
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
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
Time Frame: 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)
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
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
Time Frame: 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)
week 1, week 5, week 9, 12 weeks after completion of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA210411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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