Zero-time Exercise for Depression

NCT ID: NCT03811327

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

Zero-time Exercise group

Group Type: EXPERIMENTAL

Zero-time Exercise

Intervention Type: BEHAVIORAL

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

Waitlist group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zero-time Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

PSY005

Identifier Type: -

Identifier Source: org_study_id