Clinical trial NCT03811327: Zero-time Exercise for Depression
Official title: Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Zero-time Exercise
Depression
Lifestyle
Behavioural Activation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
measure: Change in Ecological momentary assessment (EMA)
timeFrame: Baseline, 1-week post-treatment and 4-week post treatment
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: