Major Depressive DisorderNCT02024620
Mobile Apps for the Treatment of Depression
A study testing Behavioral activation plus mobile app and Standard behavioral activation in people with Major Depressive Disorder, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Behavioral activation plus mobile app and Standard behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans aged 18 and older
- Speak and understand English
- Meet criteria for major depressive disorder
- Willing to participate in psychotherapy for depression
Who cannot join
- Current psychotic disorder diagnosis
- Current bipolar disorder
- Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
- Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System
North Little Rock, Arkansas, 72114
About this study
Official title: Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. This project evaluates the utility of this app as an adjunct to standard BA treatment. The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition. The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.
- Conditions
- Major Depressive Disorder
- Being tested
- Behavioral activation plus mobile app, Standard behavioral activation
- Keywords
- depression, technology, psychotherapy, behavioral activation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activation plus mobile appBehavioural
Standard behavioral activationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral activation plus mobile app | Experimental | Standard behavioral activation protocol with the addition of the Mood Coach mobile app to replace the paper and pencil forms used in the standard protocol. Receives: Behavioral: Behavioral activation plus mobile app |
| Standard behavioral activation | Active comparator | Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion. Receives: Behavioral: Standard behavioral activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Activation for Depression Scale-Short Form
Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
Measured: Week 1, Week 4, Week 8
Secondary outcomes (1)
Change in Depression Anxiety Stress Scales-21
Assesses symptoms of depression, anxiety, and stress in a brief format.
Measured: Week 1, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: The mobile phone app upon which the study was based was not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- National Center for PTSD
- Responsible party
- Sponsor
- Investigators
- Robert E Brady, Ph.D., Principal investigator, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024620
- Sponsor's protocol ID
- 529128
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
PubMed 21324944Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.
PubMed 21130939
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02024620
- Acronym / sponsor ID
- 529128
- Conditions
- Major Depressive Disorder
- Keywords
- depression, technology, psychotherapy, behavioral activation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The mobile phone app upon which the study was based was not available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Collaborators
- National Center for PTSD
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- 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.
Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. This project evaluates the utility of this app as an adjunct to standard BA treatment. The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition. The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral activation plus mobile app | Experimental | Behavioral: Behavioral activation plus mobile appStandard behavioral activation protocol with the addition of the Mood Coach mobile app to replace the paper and pencil forms used in the standard protocol. |
| Standard behavioral activation | Active comparator | Behavioral: Standard behavioral activationStandard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans aged 18 and older
- Speak and understand English
- Meet criteria for major depressive disorder
- Willing to participate in psychotherapy for depression
Key exclusion criteria (4 listed)
- Current psychotic disorder diagnosis
- Current bipolar disorder
- Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
- Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD
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 |
|---|---|---|
| Behavioral activation plus mobile app | Behavioural | Behavioral activation plus mobile app |
| Standard behavioral activation | Behavioural | Standard behavioral activation |
Primary outcome
Change in Behavioral Activation for Depression Scale-Short Form
Time frame: Week 1, Week 4, Week 8
Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
1 secondary outcome
Change in Depression Anxiety Stress Scales-21
Time frame: Week 1, Week 4, Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Background: PubMed 21324944Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
- Background: PubMed 21130939Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.
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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.
Robert E Brady, Ph.D. principal investigator
Central Arkansas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation plus mobile app and Standard behavioral activation in people with Major Depressive Disorder, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Dec 2015. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Behavioral Activation for Depression Scale-Short Form (time frame: Week 1, Week 4, Week 8). 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 NCT02024620, which also lists 2 linked publications.
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 15 Dec 2015.