Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
5 de mayo de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Vincent Wing-Hei Wong
- Número de teléfono: +852 39436575
- Correo electrónico: vincentwongWH@link.cuhk.edu.hk
Ubicaciones de estudio
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Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervención de medicina del estilo de vida con herramientas de autoseguimiento
Intervención en el estilo de vida que incluye dieta, sueño, ejercicio, relajación y atención plena.
Se proporcionarán herramientas de autoseguimiento, incluida una aplicación para teléfonos inteligentes y una Actigrafía.
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Intervención en el estilo de vida que incluye dieta, sueño, ejercicio, relajación y atención plena
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Experimental: Intervención pura de medicina de estilo de vida
Intervención en el estilo de vida que incluye dieta, sueño, ejercicio, relajación y atención plena.
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Intervención en el estilo de vida que incluye dieta, sueño, ejercicio, relajación y atención plena
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Sin intervención: Cuidado como de costumbre
continuar recibiendo la atención de rutina como de costumbre y recibir una intervención de LM basada en teléfonos inteligentes después de completar las evaluaciones de seguimiento
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in the Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Credibility-Expectancy Questionnaire (CEQ)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2021
Finalización primaria (Anticipado)
31 de mayo de 2022
Finalización del estudio (Anticipado)
30 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2021
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2021
Publicado por primera vez (Actual)
6 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSY015
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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