- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07597967
The Effectiveness of a One-stop Electronic Clinic for Psychological Service (eClinic) in Hong Kong
14 de mayo de 2026 actualizado por: New Life Psychiatric Rehabilitation Association
With an increasing need for effective and accessible mental health services, telepsychology can be one promising solution to narrowing the gap between demand and supply.
Our one-stop electronic clinic of psychological service (eClinic) aims to deliver evidence-based treatments to individuals with moderate to severe emotional disorders of various kinds in Hong Kong.
This study examines the cost-effectiveness and cost-efficiency of a hybrid model of telepsychology, in which contact with therapists focuses on facilitating service users' self-learning based on our online interactive modules.
Results will shed light on the benefits of telepsychology to promoting access to mental health services in Hong Kong.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
420
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.
Ubicaciones de estudio
-
-
Hong Kong
-
Hong Kong, Hong Kong, Hong Kong
- New Life Psychiatric Rehabilitation Association
-
-
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
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Individuals aged between 15 and 35 years that are able to speak, read, and write Chinese, and present with moderate to severe depression or anxiety at the time of intake.
Descripción
Inclusion Criteria:
- Screened eligible for and enrolled in the eClinic service
- Age between 15 and 35 years
- Speak, read, and write Chinese
- Present with moderate to severe depression (i.e., Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10) or anxiety (i.e., Generalized Anxiety Disorder-7 (GAD-7) total score ≥ 8)
Exclusion Criteria:
- Present with a history of psychosis in the recent 2 years
- Present with severe risk for self-harm/suicide (i.e., indicated as being at higher risk on the P4 suicidality screener during the service-related screening procedure prior to enrollment in the eClinic service)
- Present with active homicidal ideations (i.e., assessed during the service-related screening procedure prior to enrollment in the eClinic service)
- Demonstrate sub-average intelligence (e.g., based on a history of intellectual disability)
- Concurrently receive other psychological services
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The PHQ-9 measures the presence of depressive symptoms in the recent two weeks.
The scale measures the nine diagnostic criteria of major depressive disorder on a scale from 0 = not at all to 3 = nearly every day, according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV).
Total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating higher distress.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The GAD-7 assesses Generalized Anxiety Disorder (GAD) symptoms in the recent two weeks.
It consists of 7 items, each rated on a 4-point Likert scale from 0 = not at all to 3 = nearly every day.
Total score on the GAD-7 ranges from 0 to 21.
A higher GAD-7 score indicates more severe impairment related to GAD symptoms.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brief Experiential Avoidance Questionnaire (BEAQ)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The 15-item BEAQ assesses several domains of experiential avoidance.
Items are rated on a 6-point Likert scale of 1 = strong disagree to 6 = strong agree.
Total score of the BEAQ ranges from 15 to 90, with a higher score representing greater experiential avoidance.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The DERS-16 assesses level of difficulties with emotion regulation.
Each of the 16 items is rated on a 5-point Likert scale of 1 = almost never to 5 = almost always, with a total score ranges from 16 to 80.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Cognitive Distortions Questionnaire (CD-Quest)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The CD-Quest is a self-report measure that contains 15 bi-dimensional items that measure the frequency and intensity of 15 cognitive distortions.
For each type of cognitive distortions, participants indicate if it has occurred or not; for any occurrence, individuals rate the frequency and intensity of the cognitive distortion on a 3x3 grid.
Therefore, score on each item ranges from 0 = no (it did not occur) to 5 = occurs almost all the time and with an intensity of more than 70%.
Total score of the CD-Quest ranges from 0 to 75, with a higher score representing a higher frequency and intensity of cognitive distortions.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Cognitive Flexibility Inventory (CFI)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The CFI is a self-report measure of cognitive flexibility.
20 items of the CFI are rated on a 7-point Likert scale of 1 (strongly disagree) to 7 (strongly agree).
Total score of the CFI ranges from 20 to 140, with higher scores indicating greater cognitive flexibility.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Gratitude Questionnaire-5 (GQ-5)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The GQ-5 is a self-reported instrument that assesses gratitude.
Five items of the GQ-5 are rated on a 7-point Likert scale from 1 = strongly disagree to 7 = strongly agree.
Total score of the GQ-5 ranges from 5 to 35, with higher scores indicating higher level of gratitude.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Penn State Worry Questionnaire (PSWQ)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The PSWQ is a 16-item self-report instrument designed to measure the construct of worry.
Each item is rated on a 5-point Likert scale that ranges from 1 = not at all typical of me to 5 = very typical of me.
Five items are reversely scored to obtain a total score ranges from 16 to 80.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Liebowitz Social Anxiety Scale (LSAS)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The LSAS assesses fear and avoidance related to social anxiety disorder.
The 24-item scale is divided into two broad domains of situations, with 11 items on social anxiety and 13 items on performance fear.
Each of the 24 items is rated on a 4-point Likert scale of 0 = none to 3 = severe for anxiety items or usually for avoidance items.
The total score of LSAS ranges from 0 to 144.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Obsessive-Compulsive Inventory-Revised (OCI-R)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The OCI-R is an 18-item self-report scale for measuring the severity of obsessive-compulsive symptoms.
Each item is rated on a 5-point Likert scale of 0 = not at all to 4 = extremely.
The OCI-R total score ranges from 0 to 72, with higher scores indicating a greater likelihood of OCD.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The PCL-5 is a self-report measure of posttraumatic stress disorder (PTSD) symptom severity, based on its diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5).
Each of the 20 items is rated on a 5-point Likert scale of 0 = not at all to 4 = extremely.
The PCL-5 total score ranges from 0 to 80, with higher scores indicating greater PTSD severity.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Insomnia Severity Index (ISI)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The ISI evaluates the nature, severity, and impact of insomnia.
It consists of 7 items rated on a 5-point Likert scale from 0 = no problem to 4 = very severe problem, with a total score ranging from 0 to 28.
Higher scores on the ISI indicate more severe insomnia.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Short Health Anxiety Inventory (SHAI)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
The SHAI is an 18-item self-report measure that assesses an individual's concern about possibly having health illnesses of different kinds, and the catastrophic thinking about having the illnesses.
Total score of the SHAI ranges from 0 to 54, where higher scores indicate greater health anxiety.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 1-, 2-, 3-, 6-, and 12-month follow-up
|
|
Work and Social Adjustment Scale (WSAS)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The WSAS is a 5-item scale that measures self-report severity of impairment across five domains of functioning.
Each item is rated on a 9-point Likert scale of 0 = not at all to 8 = very severely.
Total score of the WSAS ranges from 0 to 40, where higher scores indicate greater functional impairment.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
|
Rosenberg Self-Esteem Scale (RSES)
Periodo de tiempo: Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
The RSE has 10 items that assess self-esteem, each rated on a 4-point Likert scale of 1 = strongly agree to 4 = strongly disagree.
Total score of the RSE ranges from 0 to 30, with lower scores suggesting lower self-esteem.
|
Baseline (week 0), post-intensive (week 5; after completion of core modules), posttreatment (week 14; completion of the intervention), and 3- and 12-month follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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 (Actual)
28 de diciembre de 2022
Finalización primaria (Actual)
31 de octubre de 2025
Finalización del estudio (Actual)
31 de octubre de 2025
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2022.106
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .