Zero-time Exercise for Depression

NCT03811327 | Completed

• 1 other identifier: PSY005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the feasibility and effectiveness of a new lifestyle-integrated exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep disturbances, and sedentary lifestyles is associated with depression. The conventional psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT), emphasises the relationship between activity and mood. One of the treatment components in CBT for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to initiate simple behaviour change as an entry-level step for facilitating BA for participants with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the effectiveness of ZTEx for the management of depressive symptoms.

Conditions

Depression

Keywords

Zero-time Exercise; Depression; Lifestyle; Behavioural Activation

Outcome Measures

Primary Outcomes (1)

• Change in the Patient Health Questionnaire (PHQ-9)

  The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression

  Baseline, 1-week post-treatment and 4-week post treatment

Secondary Outcomes (7)

• Change in Hospital Anxiety and Depression Scale (HADS)

  Baseline, 1-week post-treatment and 4-week post treatment

• Change in Insomnia Severity Index (ISI)

  Baseline, 1-week post-treatment and 4-week post treatment

• Change in Multidimensional Fatigue Inventory (MFI)

  Baseline, 1-week post-treatment and 4-week post treatment

• Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)

  Baseline, 1-week post-treatment and 4-week post treatment

• Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)

  Baseline, 1-week post-treatment and 4-week post treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Zero-time Exercise group

Behavioral: Zero-time Exercise

Waitlist group

NO INTERVENTION

Interventions

Zero-time Exercise BEHAVIORAL

A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents aged 18-65 years
• Cantonese language fluency
• Patient Health Questionnaire (PHQ-9) score ≥ 10 and ≤ 14; and
• Willingness to provide informed consent and comply with the trial protocol.

You may not qualify if:

• Pregnancy;
• Have high levels of suicidal ideation (referral information to professional services will be provided);
• Unstable psychotropic drugs within 2 weeks before study entry and throughout the treatment phase;
• Current involvement in psychotherapy for depression;
• Having unsafe conditions and are not recommended for exercising by physicians; and
• Major psychiatric, medical or neurocognitive disorders that would make participation infeasible or interfere with the adherence to physical exercising.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: May 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

HK (1)