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A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.

18 aprile 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

62

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • Devon
      • Exeter, Devon, Regno Unito, EX1 2LU
        • University of Exeter

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: eMotion
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
Nessun intervento: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression
Lasso di tempo: Two months
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)
Two months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Physical Activity
Lasso di tempo: Two months
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).
Two months
Anxiety
Lasso di tempo: Two months
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).
Two months
Affective Mood State
Lasso di tempo: Two months
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).
Two months
Self-reported physical activity
Lasso di tempo: Two months
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).
Two months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Fidelity of receipt
Lasso di tempo: Two months
The website will be assessed by asking questions understanding, perceived understanding the key learning goals for participants in all groups.
Two months
Fidelity of enactment
Lasso di tempo: Two months
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.
Two months
Participant satisfaction
Lasso di tempo: Two months
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.
Two months
Participant views of intervention
Lasso di tempo: Two months
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.
Two months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Exeter

Collaboratori

University of Glasgow

Investigatori

  • Investigatore principale: Jeffrey D Lambert, MSc, University of Exeter

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2016

Completamento primario (Effettivo)

15 aprile 2017

Completamento dello studio (Effettivo)

15 aprile 2017

Date di iscrizione allo studio

Primo inviato

15 giugno 2016

Primo inviato che soddisfa i criteri di controllo qualità

13 marzo 2017

Primo Inserito (Effettivo)

20 marzo 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 aprile 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 aprile 2018

Ultimo verificato

1 aprile 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1516/029

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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