Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
5 mei 2021 bijgewerkt door: Fiona YY Ho, Chinese University of Hong Kong
Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial
This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression.
Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants.
Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1.
The randomization will be performed by an independent assessor using a computer-generated list of numbers.
In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial.
Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19).
The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer.
The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments.
Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed.
In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
90
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Vincent Wing-Hei Wong
- Telefoonnummer: +852 39436575
- E-mail: vincentwongWH@link.cuhk.edu.hk
Studie Locaties
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Sha Tin, Hongkong
- The Chinese University of Hong Kong
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Hong Kong residents aged ≥ 18 years
- Cantonese language fluency and readability
- A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
- Possession of an internet-enabled mobile device (iOS or Android operating system)
- Willingness to provide informed consent and comply with the trial protocol
Exclusion Criteria:
- Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
- Any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
- Current involvement in lifestyle changes supervised by professionals
- Unstable medication or current participation in any psychotherapy for depression
- Pregnancy
- Hospitalization
- Current participation in any other trial(s)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Leefstijlgeneeskundige interventie met self-tracking tools
Leefstijlinterventie inclusief dieet, slaap, lichaamsbeweging, ontspanning en mindfulness.
Self-tracking-tools, waaronder een smartphone-applicatie en een Actigraphy, worden gegeven.
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Leefstijlinterventie inclusief dieet, slaap, lichaamsbeweging, ontspanning en mindfulness
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Experimenteel: Pure leefstijlgeneeskundige interventie
Leefstijlinterventie inclusief dieet, slaap, lichaamsbeweging, ontspanning en mindfulness.
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Leefstijlinterventie inclusief dieet, slaap, lichaamsbeweging, ontspanning en mindfulness
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Geen tussenkomst: Zorg zoals gewoonlijk
doorgaan met het ontvangen van de gebruikelijke zorg en een op de smartphone gebaseerde LM-interventie krijgen na voltooiing van de vervolgbeoordelingen
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in the Patient Health Questionnaire (PHQ-9)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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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 after treatment, and 12 weeks after the treatment sessions are completed
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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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 after treatment, and 12 weeks after the treatment sessions are completed
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Change in Insomnia Severity Index (ISI)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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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 after treatment, and 12 weeks after the treatment sessions are completed
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Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health.
The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines.
A higher score indicated a better QoL.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Change in the Health-Promoting Lifestyle Profile (HPLP II)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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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 after treatment, and 12 weeks after the treatment sessions are completed
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Change in the Sheehan Disability Scale (SDS)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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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 after treatment, and 12 weeks after the treatment sessions are completed
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Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Tijdsspanne: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version a short form of the IPAQ-C.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the Credibility-Expectancy Questionnaire (CEQ)
Tijdsspanne: Baseline and immediately after treatment
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The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
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Baseline and immediately after treatment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 juli 2021
Primaire voltooiing (Verwacht)
31 mei 2022
Studie voltooiing (Verwacht)
30 juni 2022
Studieregistratiedata
Eerst ingediend
5 mei 2021
Eerst ingediend dat voldeed aan de QC-criteria
5 mei 2021
Eerst geplaatst (Werkelijk)
6 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 mei 2021
Laatste update ingediend die voldeed aan QC-criteria
5 mei 2021
Laatst geverifieerd
1 mei 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PSY015
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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