A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
18 de abril de 2018 actualizado por: University of Exeter
A Pilot Randomized Controlled Trial of a Web-based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression: the eMotion Study.
Physical activity has many potential mood enhancing benefits, and may be as effective as anti-depressants and psychological therapies for treating depression and low mood.
However, getting people with depression to become more active is challenging.
Behavioural Activation (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to positive environmental stimuli which could provide an effective delivery mechanism for increasing physical activity for people who are more sedentary than the general population.
The purpose of this study is to examine the feasibility of delivering a theory informed online intervention combining physical activity and BA (eMotion) to people with depression, and to examine its effects on depressive symptoms and physical activity.
Descripción general del estudio
Descripción detallada
A randomised controlled trial (RCT) design will be used in this study. 120 participants experiencing depressive symptoms (>10 on the PHQ-8) over the age of 18 will be recruited from the community. Participants will be eligible to participate if the over 18, score over 10 on the PHQ-8 and, are able to walk unaided for at least 5 minutes and have access to the internet. Following baseline measures, participants will be randomised in a 1:1 ratio to the intervention or waiting list control arm and be followed up at 2 and 5 months. Those randomised to the intervention arm will receive eMotion which is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity. Main outcomes of interest include recruitment, retention, fidelity and acceptability. Baseline and follow up measures will also include the PHQ-8, and objective (GENEActvie accelerometers) and subjective (IPAQ) measures of physical activity. A parallel process evaluation will run alongside the RCT.
If effective, this intervention has the potential to improve depressive symptoms in a wide range of hard to reach people in the community and increase their physical activity. Further evaluation in a full scale RCT is planned pending results of this trial.
Tipo de estudio
Intervencionista
Inscripción (Actual)
62
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.
Ubicaciones de estudio
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Devon
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Exeter, Devon, Reino Unido, EX1 2LU
- University of Exeter
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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
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adults (aged ≥18 years).
- Adults with possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults living in the UK.
- Having access to the internet.
- Able to walk continuously and unaided for a minimum of 5 minutes.
- Provision of informed consent to participate.
Exclusion Criteria:
- Adults (aged <18 years).
- Adults without possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults not living in the UK.
- No access to the internet.
- Not able to walk continuously and unaided for a minimum of 5 minutes.
- Lacking capacity to give informed consent to participate.
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 de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: eMotion intervention
Subjects randomised to the intervention arm will receive eMotion for two months.
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity.
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eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
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Sin intervención: Waiting list control
Subjects in the waiting list control group will be given no intervention for two months; the control group will then be able to access eMotion if they wish but this will not form part of the research project
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression
Periodo de tiempo: Two months
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Depression will be measured using tThe Personal Health Questionnaire (PHQ-8).
The PHQ-8 is an 8 item measure used to measure the frequency of depressive symptoms.
This is a freely available brief self-report questionnaire which assesses depressive symptoms based on the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV).
Each item is rated on a scale of 0 to 3 with a maximum score of 24.
It has been shown to have good validity, reliability, sensitivity and specificity.
It has also been shown to discriminate between levels of major and major severe depression being 10-19, and 20-23 respectively (Kroenke et al., 2009)
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Two months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Physical Activity
Periodo de tiempo: Two months
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Objective physical activity will be assessed using GeneACTIVE wrist worn accelerometers.
The accelerometer is a small wrist worn device that measures and records acceleration.
1 minute epochs will be used to measure movement, with higher counts per minute reflecting higher levels of physical activity as recommended in previous studies (Helgadóttir, Forsell, & Ekblom, 2015; Mailey et al., 2010).
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Two months
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Anxiety
Periodo de tiempo: Two months
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General Anxiety Disorder (GAD-7) is a 7 item scale which measures symptoms and severity of anxiety based on the DSM-IV criteria and included in the minimum IAPT data set (Spitzer, Kroenke, Williams, & Lowe, 2006).
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Two months
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Affective Mood State
Periodo de tiempo: Two months
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Ecological Momentary Assessment of Mood (EMA) will be taken using a one item 10 point scale asking the participant to rate their mood where 1 = sad and 10 = happy.
This will be taken twice per day randomly over five days during baseline data collection and at two months follow up using 'Text local', a text messaging service which allows participants to respond with a number response indicating their current mood at that point in time.
This approach is adapted from previous research (van Rijsbergen, Bockting, Berking, Koeter, & Schene, 2012).
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Two months
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Self-reported physical activity
Periodo de tiempo: Two months
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Self-reported physical activity will be measured using the short-form IPAQ which measures Minutes per week of moderate to vigorous physical activity will be assessed by using the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a valid cross national measure of self-reported physical activity (Craig et al., 2003).
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Two months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fidelity of receipt
Periodo de tiempo: Two months
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The website will be assessed by asking questions understanding, perceived understanding the key learning goals for participants in all groups.
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Two months
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Fidelity of enactment
Periodo de tiempo: Two months
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Fidelity of enactment will be measured by asking participants in all groups if they have carried out specific behaviour change techniques relating to physical activity, and behavioural activation along with rating confidence.
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Two months
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Participant satisfaction
Periodo de tiempo: Two months
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The Client Satisfaction Questionnaire - Short Form (CSQ-SF).
This is a 4 item measure which will be used to assess participant satisfaction in eMotion 2 months post randomization.
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Two months
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Participant views of intervention
Periodo de tiempo: Two months
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Qualitative interviews after the final intervention session, all participants who receive eMotion will be invited to participate in a semi structured interview over the phone.
The purpose of this is to further examine the acceptability of the intervention and any suggestions for improvement which can be absorbed into a next trial.
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Two months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeffrey D Lambert, MSc, University of Exeter
Publicaciones y enlaces útiles
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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)
1 de mayo de 2016
Finalización primaria (Actual)
15 de abril de 2017
Finalización del estudio (Actual)
15 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2016
Primero enviado que cumplió con los criterios de control de calidad
13 de marzo de 2017
Publicado por primera vez (Actual)
20 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de abril de 2018
Última verificación
1 de abril de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1516/029
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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