Clinical trial NCT03084055: A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
Official title: A Pilot Randomized Controlled Trial of a Web-based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression: the eMotion Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-03-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression
timeFrame: Two months
Secondary outcomes:
measure: Objective Physical Activity
timeFrame: Two months
measure: Anxiety
timeFrame: Two months
measure: Affective Mood State
timeFrame: Two months
measure: Self-reported physical activity
timeFrame: Two months
Other outcomes:
measure: Fidelity of receipt
timeFrame: Two months
measure: Fidelity of enactment
timeFrame: Two months
measure: Participant satisfaction
timeFrame: Two months
measure: Participant views of intervention
timeFrame: Two months
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Jeffrey D Lambert, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambert JD, Greaves CJ, Farrand P, Price L, Haase AM, Taylor AH. Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Jul 16;20(7):e10112. doi: 10.2196/10112.