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Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

5. maj 2021 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
      • Sha Tin, Hong Kong
        • The Chinese University of Hong Kong

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Hong Kong residents aged ≥ 18 years
  2. Cantonese language fluency and readability
  3. A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
  4. Possession of an internet-enabled mobile device (iOS or Android operating system)
  5. Willingness to provide informed consent and comply with the trial protocol

Exclusion Criteria:

  1. 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)
  2. 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)
  3. Current involvement in lifestyle changes supervised by professionals
  4. Unstable medication or current participation in any psychotherapy for depression
  5. Pregnancy
  6. Hospitalization
  7. Current participation in any other trial(s)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Livsstilsmedicinsk intervention med selvsporingsværktøjer
Livsstilsintervention inklusive kost, søvn, motion, afslapning og mindfulness. Selvsporingsværktøjer inklusive en smartphone-applikation og en Actigraphy vil blive givet.
Adfærdsmæssigt: Livsstilsmedicin
Livsstilsintervention inklusive kost, søvn, motion, afslapning og mindfulness
Eksperimentel: Ren livsstilsmedicinsk intervention
Livsstilsintervention inklusive kost, søvn, motion, afslapning og mindfulness.
Adfærdsmæssigt: Livsstilsmedicin
Livsstilsintervention inklusive kost, søvn, motion, afslapning og mindfulness
Ingen indgriben: Pleje-som-sædvanligt
fortsætte med at modtage den rutinemæssige pleje som normalt og få en smartphone-baseret LM-intervention efter afslutningen af ​​opfølgende vurderinger

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Patient Health Questionnaire (PHQ-9)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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).
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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).
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Change in Insomnia Severity Index (ISI)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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.
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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.
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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.
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Change in the Sheehan Disability Scale (SDS)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Tidsramme: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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.
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Credibility-Expectancy Questionnaire (CEQ)
Tidsramme: Baseline and immediately after treatment
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Baseline and immediately after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2021

Primær færdiggørelse (Forventet)

31. maj 2022

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

5. maj 2021

Først indsendt, der opfyldte QC-kriterier

5. maj 2021

Først opslået (Faktiske)

6. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSY015

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Kliniske forsøg med Depression

Kliniske forsøg med Livsstilsmedicin

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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