Self-help Lifestyle Medicine App and Booklets for Depression
A Comparison of Self-help Lifestyle Modification Delivered by a Smartphone App and Booklets in Managing Depressive Symptoms: a Pilot Randomised Controlled Trial.
This study aims to compare self-help lifestyle medicine (LM) delivered by a smartphone app and booklets in managing depressive symptoms in a Chinese population.
This study is a randomised controlled trial. First, informed consent will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM app group, the LM booklet group, and the waitlist control group, in a ratio of 1:1:1. The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. The booklet group will receive 8 LM booklets with identical content with the LM app. The waitlist control group will receive access to the app and booklets at the end of the study. The whole intervention lasts 8 weeks. Participants will also receive 2 messages per week from the researcher to check and prompt motivation and adherence. Participants will complete assessment before, immediately after intervention, at one month and 12-week follow up.
Przegląd badań
Status
Warunki
Szczegółowy opis
As lifestyle plays an important role in the pathogenesis of depression, lifestyle medicine (LM) emerges as a new way to alleviate depressive symptoms (Sarris & O'Neil, 2016). Booklets have been shown as an inexpensive and effective delivery modality of lifestyle modification among individuals with physical conditions (Wong, Chair & Wong, 2017). Meanwhile, a recent meta-analysis supports the efficacy of mobile applications in improving depressive symptoms (Linardon, Cujipers, Carlbring, Messer & Fuller-Tyszkiewicz, 2019). Notably, the efficacy of lifestyle intervention using booklets and app have not been compared. This pilot study can inform the field about the efficacy of lifestyle intervention using two self-help delivery modalities and offer new ways to better managing depressive symptoms.
This study will be a randomised controlled trial comparing self-help LM delivered by a smartphone app and booklets in improving depression. For a pilot study, a sample size of 12 per group is recommended (Julious, 2005). Considering an estimation of 20% attrition at the three assessment time points, the final sample size is 90, with 30 participants in each group.
The LM booklet group will receive a pocket size 6-page booklet weekly that covers 8 lifestyle medicine themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology. Exercises based on cognitive behavioural therapy and guidance to set and meet short term and long-term goals are featured in the booklets. The booklet series is reviewed by a panel of experts including clinical psychologists, psychiatrists, dietitians, physical trainers, and traditional Chinese Medicine practitioners. The app group will receive access to a mobile app that offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges and record of goals. The waitlist control group will receive access to the app and booklets at the end of the study.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Chung Yan Chow, Undergraduate
- Numer telefonu: 39436575
- E-mail: pmhlab@cuhk.edu.hk
Lokalizacje studiów
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Sha Tin, Hongkong
- The Chinese University of Hong Kong
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Participants with elevated depressive symptoms as defined by PHQ-9 score 10 or above
- Hong Kong residents
- Aged 18 or above
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
Exclusion Criteria:
- Pregnancy;
- Using medication or psychotherapy for depression;
- Currently participating in other psychological intervention studies;
- Cognitive impairment;
- Having unsafe conditions and are not recommended for physical activity or a change in diet by physicians;
- Self-disclosure of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or may interfere with the adherence of the lifestyle modification;
- Any suicidal ideation (scoring above 2 in item 9 in BDI-II) Participants with any urgent health necessity were excluded and referred.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Lifestyle medicine smartphone app
The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management.
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The lifestyle medicine app offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges, record of goals, and ecological momentary assessments of diet, physical activity, sleep, stress and mood.
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Eksperymentalny: lifestyle medicine booklets
The booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app.
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Participants will receive a pocket size 6-page booklet weekly over 8 weeks that covers 8 lifestyle medicine, mental health and CBT themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology, and guides participants to set and meet short term and long-term goals.
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Pozorny komparator: waitlist control
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
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The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in the Patient Health Questionnaire (PHQ-9)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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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).
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Self-developed survey
Ramy czasowe: Baseline
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A self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
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Baseline
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Change in the World Health Organization 5-item Well-Being Index
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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This is a 5-item measure of global subjective well-being.
The internal consistency prior to treatment was 0.86.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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SF-6D is a preference-based single index measure of health.
A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Perceived Stress Scale (PSS)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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The PSS measures the perceived amount of stress experienced over the past month.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Sheehan Disability Scale (SDS)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Health-Promoting Lifestyle Profile (HPLP II)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version.
Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Change in the Insomnia Severity Index (ISI)
Ramy czasowe: baseline, immediately post-intervention, 4-week and 12-week follow-up
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The ISI is a 7-item scale designed to evaluate perceived insomnia severity.
Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
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baseline, immediately post-intervention, 4-week and 12-week follow-up
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PSY017
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Lifestyle medicine smartphone app
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Chinese University of Hong KongRekrutacyjnyBól mięśniowo-szkieletowy | Chroniczny ból | Zarządzanie bólem | Układ mięśniowo-szkieletowyHongkong
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University of Alabama at BirminghamEli Lilly and CompanyRejestracja na zaproszenieOtyłość i schorzenia związane z otyłościąStany Zjednoczone
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University of Missouri-ColumbiaZakończonyMłodzież z nadwagąStany Zjednoczone
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Faculty Hospital AGEL SkalicaJeszcze nie rekrutacjaAPP opracowuje wprowadzanie danych od pacjenta z owrzodzeniem stopy