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

NCT05394753 | Unknown

• 1 other identifier: EA210411
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Insomnia; Depression, Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (26)

• Change of Sleep Diary Measure - Time in Bed (TIB)

  week 1, week 9, 12 weeks after completion of intervention

• Change of Sleep Diary Measure - Total Sleep Time (TST)

  week 1, week 9, 12 weeks after completion of intervention

• Change of Sleep Diary Measure - Sleep Onset Latency (SOL)

  week 1, week 9, 12 weeks after completion of intervention

• Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)

  week 1, week 9, 12 weeks after completion of intervention

• Change of Sleep Diary Measure - Sleep Efficiency (SE)

  week 1, week 9, 12 weeks after completion of intervention

Study Arms (2)

Unified Protocol

EXPERIMENTAL

8-session group-based intervention

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.

Interventions

Unified Protocol for mood disorders BEHAVIORAL

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.

Unified Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
• currently receiving taking other psychosocial interventions

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Shirley X Li, PhD

CONTACT

39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: May 27, 2022
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

HK (1)