Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
5 maj 2021 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
90
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Vincent Wing-Hei Wong
- Telefonnummer: +852 39436575
- E-post: vincentwongWH@link.cuhk.edu.hk
Studieorter
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Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Livsstilsmedicinsk intervention med verktyg för självspårning
Livsstilsintervention inklusive kost, sömn, träning, avslappning och mindfulness.
Självspårningsverktyg inklusive en smartphoneapplikation och en Actigraphy kommer att ges.
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Livsstilsintervention inklusive kost, sömn, träning, avslappning och mindfulness
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Experimentell: Ren livsstilsmedicinsk intervention
Livsstilsintervention inklusive kost, sömn, träning, avslappning och mindfulness.
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Livsstilsintervention inklusive kost, sömn, träning, avslappning och mindfulness
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Inget ingripande: Vård-som-vanligt
fortsätta att få den rutinmässiga vården som vanligt och ges en smartphonebaserad LM-intervention efter avslutade uppföljningsbedömningar
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in the Patient Health Questionnaire (PHQ-9)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in the Credibility-Expectancy Questionnaire (CEQ)
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 juli 2021
Primärt slutförande (Förväntat)
31 maj 2022
Avslutad studie (Förväntat)
30 juni 2022
Studieregistreringsdatum
Först inskickad
5 maj 2021
Först inskickad som uppfyllde QC-kriterierna
5 maj 2021
Första postat (Faktisk)
6 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PSY015
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