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

NCT03084055 | Completed

• 1 other identifier: 1516/029
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Depression

  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

Secondary Outcomes (4)

• Objective Physical Activity

  Two months

• Anxiety

  Two months

• Affective Mood State

  Two months

• Self-reported physical activity

  Two months

Other Outcomes (4)

• Fidelity of receipt

  Two months

• Fidelity of enactment

  Two months

• Participant satisfaction

  Two months

Study Arms (2)

eMotion intervention

EXPERIMENTAL

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.

Behavioral: eMotion

Waiting list control

NO INTERVENTION

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

Interventions

eMotion BEHAVIORAL

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

eMotion intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Exeter: lead
• University of Glasgow: collaborator

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30012547 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jeffrey D Lambert, MSc

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: March 20, 2017
• Study Start: May 1, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

GB (1)