Depressive SymptomsNCT03084055
A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
A study testing eMotion in people with Depressive Symptoms, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- eMotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2016to 15 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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
- Being tested
- eMotion
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMotionBehavioural
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two months
Secondary outcomes (4)
Objective Physical Activity
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).
Measured: Two months
Anxiety
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).
Measured: Two months
Affective Mood State
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).
Measured: Two months
Self-reported physical activity
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).
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 May 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jeffrey D Lambert, MSc, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084055
- Sponsor's protocol ID
- 1516/029
- Status last verified
- Apr 2018
- First submitted
- 15 Jun 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30012547
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03084055
- Acronym / sponsor ID
- 1516/029
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eMotion intervention | Experimental | Behavioral: eMotionSubjects 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMotioneMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity | Behavioural | eMotion intervention |
Primary outcome
Depression
Time frame: 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)
4 secondary outcomes
Objective Physical Activity
Time frame: Two months
Anxiety
Time frame: Two months
Affective Mood State
Time frame: Two months
Self-reported physical activity
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 30012547Lambert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey D Lambert, MSc principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMotion in people with Depressive Symptoms, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.