Clinical trial NCT04227587: Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia Disorder
Official title: Zero-time Exercise on Inactive Adults With Insomnia Disorder: A Randomized Controlled Trial and Mixed-method Process Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia, Primary
Keywords: insomnia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 140
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 randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder

Detailed description: This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder; (2) identify the facilitators and barriers of ZTEx adherence, (3) explore the possible mechanisms of impact on ZTEx adherence and the same abovementioned outcomes.

This RCT consists of two phases. In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx intervention or the sleep hygiene education (SHE) comparison group. They will receive two 2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction for 24 weeks. After assessment at week 8, for the second phase of the study (weeks 9-24), which is a proof-of-concept pilot nested in the RCT, subjects in the ZTEx group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) subgroup or an ZTEx without WhatsApp reminder (ZTEx alone) subgroup to evaluate the effects of WhatsApp reminders on exercise adherence and the same outcomes. Mixed methods process evaluation will be conducted. Post-training and post-follow-up qualitative focus group interviews will be conducted; facilitators, barriers, and mediators will be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents,
2. ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
3. who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
4. scored at least 10 points in the Insomnia Severity Index,
5. are ambulant and can independently perform daily activities,
6. are physically inactive, defined as not having participated in at least 150 min of moderate intensity or 75 min of vigorous intensity physical activity a week, or the equivalent combination over the previous 3 months by self-report
7. have a smartphone compatible with WhatsApp, and
8. willing to give informed consent

Exclusion Criteria:

1. any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
2. other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
3. any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
4. taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
5. impaired cognitive functioning (\<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
6. pregnant;
7. shift work;
8. whose physical condition is such that physicians recommend that they refrain from exercising; and
9. fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)

Primary outcomes:
measure: Change in the Insomnia Severity Index score
timeFrame: Baseline, week 8, week 16, week 24
Secondary outcomes:
measure: Sleep diary (7-day)
timeFrame: baseline, week 8, week 16, week 24
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline, week 8, week 16, week 24
measure: Multidimensional fatigue inventory-20
timeFrame: baseline, week 8, week 16, week 24
measure: Actigraphy (7-day)
timeFrame: baseline, week 8, week 16, week 24
measure: Accelerometer (7-day)
timeFrame: baseline, week 8, week 16, week 24
measure: Change in WAIS-IV Color Trails Test
timeFrame: baseline, week 8, week 16, week 24
measure: Change in WAIS-IV Stroop color-word Test
timeFrame: baseline, week 8, week 16, week 24
measure: Change in Digit Span-backward test
timeFrame: baseline, week 8, week 16, week 24
measure: Change in the Wisconsin Card Sorting Test
timeFrame: baseline, week 8, week 16, week 24
Other outcomes:
measure: Intervention adherence (7 day)
timeFrame: week 1-8, week 12-15, week 20-23
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
affiliation: School of Nursing, the Hong Kong Polytechnic University
name: WF Yeung
role: PRINCIPAL_INVESTIGATOR
References: