Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
5 mai 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Vincent Wing-Hei Wong
- Numéro de téléphone: +852 39436575
- E-mail: vincentwongWH@link.cuhk.edu.hk
Lieux d'étude
-
-
-
Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention en médecine du mode de vie avec des outils d'auto-suivi
Intervention sur le mode de vie, y compris l'alimentation, le sommeil, l'exercice, la relaxation et la pleine conscience.
Des outils d'auto-suivi dont une application smartphone et une Actigraphie seront mis à disposition.
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Intervention sur le mode de vie, y compris l'alimentation, le sommeil, l'exercice, la relaxation et la pleine conscience
|
|
Expérimental: Intervention en médecine de style de vie pure
Intervention sur le mode de vie, y compris l'alimentation, le sommeil, l'exercice, la relaxation et la pleine conscience.
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Intervention sur le mode de vie, y compris l'alimentation, le sommeil, l'exercice, la relaxation et la pleine conscience
|
|
Aucune intervention: Soins habituels
continuer à recevoir les soins de routine comme d'habitude et recevoir une intervention LM basée sur un smartphone après la fin des évaluations de suivi
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Patient Health Questionnaire (PHQ-9)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Délai: 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)
Délai: 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.
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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)
Délai: 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.
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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)
Délai: 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
|
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Change in the Sheehan Disability Scale (SDS)
Délai: 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
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Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Délai: 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.
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Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Credibility-Expectancy Questionnaire (CEQ)
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 juillet 2021
Achèvement primaire (Anticipé)
31 mai 2022
Achèvement de l'étude (Anticipé)
30 juin 2022
Dates d'inscription aux études
Première soumission
5 mai 2021
Première soumission répondant aux critères de contrôle qualité
5 mai 2021
Première publication (Réel)
6 mai 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 mai 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2021
Dernière vérification
1 mai 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PSY015
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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