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

NCT ID: NCT03084055

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-04-15

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.

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

eMotion

Intervention Type: BEHAVIORAL

eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eMotion

eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey D Lambert, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

University of Exeter

Exeter, Devon, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30012547 (View on PubMed)

Other Identifiers

1516/029

Identifier Type: -

Identifier Source: org_study_id