A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
18 avril 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
62
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.
Lieux d'étude
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Devon
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Exeter, Devon, Royaume-Uni, EX1 2LU
- University of Exeter
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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
Oui
Sexes éligibles pour l'étude
Tout
La description
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 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 à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depression
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective Physical Activity
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fidelity of receipt
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffrey D Lambert, MSc, University of Exeter
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Réel)
1 mai 2016
Achèvement primaire (Réel)
15 avril 2017
Achèvement de l'étude (Réel)
15 avril 2017
Dates d'inscription aux études
Première soumission
15 juin 2016
Première soumission répondant aux critères de contrôle qualité
13 mars 2017
Première publication (Réel)
20 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 avril 2018
Dernière vérification
1 avril 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1516/029
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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