Major Depressive DisorderNCT01752608
Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder
A study testing eCBT Mood in people with Major Depressive Disorder, run by MindApps at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of an electronic cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting of a mood monitoring handheld computer application in the treatment of patients with mild to moderate major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- eCBT Mood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to May 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 18 and 65 at the date of consent.
- Diagnosis of MDD consistent with the DSM-IV-TR as assessment by the Mini International Neuropsychiatric Interview (MINI).
- Owns and has access to an iPhone or iPod Touch capable of downloading and running either eCBT or the comparator mood monitoring application.
- At the screening and visits, must exhibit mild to moderate MDD with scores between 17 and 34 on the MADRS, inclusive. Subjects with scores >34 on the MADRS will be referred by the Study Investigator for alternative psychotherapeutic and/or pharmacological care for their depression.
- Note that no subjects are to be discontinued from any pharmacotherapies used to treat depression solely for the purpose of qualifying for this study. Be willing and able to refrain from the following therapies for the duration of the study:
- All approved pharmacotherapies for MDD, including serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, tricyclic and tetracyclic antidepressants, bupropion, mood stabilizers, and adjunctive antipsychotics.
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- Medical device therapies for depression, including transcranial magnetic stimulation, vagal stimulation, electroconvulsive shock therapy, and others.
- Beginning any type of group or individual psychotherapy.
- Beginning another clinical trial for major depressive disorder or other condition.
- Patients' primary language must be English.
- Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
Who cannot join
- Depression severity, as measured by either:
- Clinician judgment that the patient's depression is too severe to make self-help resource a viable treatment option.
- Depression severity as measured by a scores >34 on the MADRS.
- Clinician assessed high risk of suicide or self-harm.
- Intellectual disability or physical limitation that would prevent use of the computerized handheld intervention.
- Comorbid psychopathology where the primary disorder is not depression.
- Within the past 3 months has had a course of treatment with psychotherapy or pharmacotherapy for depression.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Compass Research, LLC: North Clinic
Leesburg, Florida, 34748
Compass Research LLC
Orlando, Florida, 32806
About this study
Official title: A Randomized, Comparator-Controlled, Two-Arm, Parallel Group Study to Determine the Safety and Efficacy of eCBT Mood®, a Handheld, Computerized, Electronic Cognitive Behavioral Therapy Application, in Patients With Major Depressive Disorder
The primary objective of this study is to evaluate the safety and efficacy of an electronic cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting of a mood monitoring handheld computer application in the treatment of patients with mild to moderate major depressive disorder.
Read the detailed description
This is a prospective, randomized, comparator-controlled, two-arm, parallel group study to examine the safety and efficacy of eCBT Mood, a handheld, computerized, electronic cognitive behavioral therapy (CBT) application, in patients with major depressive disorder (MDD). The study will involve 100 patients with mild to moderate MDD randomly assigned to daily use of either a CBT application focused on depression ('eCBT Mood'; MindApps, llc) or a comparator-controlled group using a mood monitoring application ('Mood Tracker'; GP International). This study design and duration of the study is consistent with other studies employing comparator-controlled designs in the study of CBT interventions, including computerized CBT interventions, among patients with MDD (e.g., Andrews et al., 2010; McKendree-Smith et al., 2003).
After being screened to ensure that the patients meet the required diagnostic, depression severity, and other inclusion criteria, patients will be randomly assigned (1:1) to use either eCBT Mood, a computer application running on the Apple® iPhone™ or iPod Touch® handheld computer platforms. The application includes: (1) a psychoeducation module on the relationships among thoughts, feelings, and behaviors, (2) a 6-item daily depression assessment with the option to e-mail the summary score and suicidal ideation assessment response to a 3rd party, (3) a negative automatic thought identification module, (4) a feelings and thoughts log, (5) a module enabling the user to challenge their negative automatic thoughts, (6) an assessment and challenge module regarding core beliefs which underlie many automatic thoughts, (7) optional compliance reminders to use the application or take medicines, and (8) links to behavioral science-based online content regarding MDD from PsychCentral (see www.psychcentral.com). In contrast, the comparator control condition will use Mood Tracker, which is also a a computer application running on the Apple iPhone or iPod Touch handheld computer platforms. This application enables users to rate their mood using expressive faces on a daily basis, log about their daily feelings, and also has an option enabling an e-mail to be sent to a 3rd party regarding their daily mood ratings.
Throughout the 8-week study period, patients will complete both in-person and telephone-based assessments of their depression severity, mood, frequency of negative automatic thoughts, and safety assessments.
- Conditions
- Major Depressive Disorder
- Being tested
- eCBT Mood
- Keywords
- Depression, Real-time, iPhone, CBT, Cognitive behavioral therapy
- 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.
eCBT MoodBehavioural
A handheld, computerized, electronic cognitive behavioral therapy (CBT) application
| Study group | Role | What they receive |
|---|---|---|
| eCBT Mood | Experimental | Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch. Receives: Behavioral: eCBT Mood |
| Mood Tracker | No intervention | Mood monitoring application running on the iPhone and iPod Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: Change from baseline to Week 8
Secondary outcomes (3)
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Measured: Change from baseline to Week 8
Beck Depression Inventory, 2nd Edition
Measured: Change from baseline to Week 8
Profile of Mood States, Short-Form (POMS-SF)
Measured: Change from baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindApps
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hufford, Phd, Study chair, CEO of MindApps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752608
- Sponsor's protocol ID
- eCBT 201
- Status last verified
- Oct 2015
- First submitted
- 16 Dec 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparator-Controlled, Two-Arm, Parallel Group Study to Determine the Safety and Efficacy of eCBT Mood®, a Handheld, Computerized, Electronic Cognitive Behavioral Therapy Application, in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01752608
- Acronym / sponsor ID
- eCBT 201
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Real-time, iPhone, CBT, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MindAppsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Dec 2012 (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.
The primary objective of this study is to evaluate the safety and efficacy of an electronic cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting of a mood monitoring handheld computer application in the treatment of patients with mild to moderate major depressive disorder.
Detailed description
This is a prospective, randomized, comparator-controlled, two-arm, parallel group study to examine the safety and efficacy of eCBT Mood, a handheld, computerized, electronic cognitive behavioral therapy (CBT) application, in patients with major depressive disorder (MDD). The study will involve 100 patients with mild to moderate MDD randomly assigned to daily use of either a CBT application focused on depression ('eCBT Mood'; MindApps, llc) or a comparator-controlled group using a mood monitoring application ('Mood Tracker'; GP International). This study design and duration of the study is consistent with other studies employing comparator-controlled designs in the study of CBT interventions, including computerized CBT interventions, among patients with MDD (e.g., Andrews et al., 2010; McKendree-Smith et al., 2003).
After being screened to ensure that the patients meet the required diagnostic, depression severity, and other inclusion criteria, patients will be randomly assigned (1:1) to use either eCBT Mood, a computer application running on the Apple® iPhone™ or iPod Touch® handheld computer platforms. The application includes: (1) a psychoeducation module on the relationships among thoughts, feelings, and behaviors, (2) a 6-item daily depression assessment with the option to e-mail the summary score and suicidal ideation assessment response to a 3rd party, (3) a negative automatic thought identification module, (4) a feelings and thoughts log, (5) a module enabling the user to challenge their negative automatic thoughts, (6) an assessment and challenge module regarding core beliefs which underlie many automatic thoughts, (7) optional compliance reminders to use the application or take medicines, and (8) links to behavioral science-based online content regarding MDD from PsychCentral (see www.psychcentral.com). In contrast, the comparator control condition will use Mood Tracker, which is also a a computer application running on the Apple iPhone or iPod Touch handheld computer platforms. This application enables users to rate their mood using expressive faces on a daily basis, log about their daily feelings, and also has an option enabling an e-mail to be sent to a 3rd party regarding their daily mood ratings.
Throughout the 8-week study period, patients will complete both in-person and telephone-based assessments of their depression severity, mood, frequency of negative automatic thoughts, and safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCBT Mood | Experimental | Behavioral: eCBT MoodElectronic cognitive behavioral therapy application running on the iPhone and iPod Touch. |
| Mood Tracker | No intervention | –Mood monitoring application running on the iPhone and iPod Touch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients between the ages of 18 and 65 at the date of consent.
- Diagnosis of MDD consistent with the DSM-IV-TR as assessment by the Mini International Neuropsychiatric Interview (MINI).
- Owns and has access to an iPhone or iPod Touch capable of downloading and running either eCBT or the comparator mood monitoring application.
- At the screening and visits, must exhibit mild to moderate MDD with scores between 17 and 34 on the MADRS, inclusive. Subjects with scores >34 on the MADRS will be referred by the Study Investigator for alternative psychotherapeutic and/or pharmacological care for their depression.
- Note that no subjects are to be discontinued from any pharmacotherapies used to treat depression solely for the purpose of qualifying for this study. Be willing and able to refrain from the following therapies for the duration of the study:
Key exclusion criteria (7 listed)
- Depression severity, as measured by either:
- Clinician judgment that the patient's depression is too severe to make self-help resource a viable treatment option.
- Depression severity as measured by a scores >34 on the MADRS.
- Clinician assessed high risk of suicide or self-harm.
- Intellectual disability or physical limitation that would prevent use of the computerized handheld intervention.
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 |
|---|---|---|
| eCBT MoodA handheld, computerized, electronic cognitive behavioral therapy (CBT) application | Behavioural | eCBT Mood |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Change from baseline to Week 8
3 secondary outcomes
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Time frame: Change from baseline to Week 8
Beck Depression Inventory, 2nd Edition
Time frame: Change from baseline to Week 8
Profile of Mood States, Short-Form (POMS-SF)
Time frame: Change from baseline to 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 14 Oct 2015.
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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.
Michael Hufford, Phd study chair
CEO of MindApps
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCBT Mood in people with Major Depressive Disorder, run by MindApps at 2 sites 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 11 inclusion and 7 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Change from baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.