DepressionNCT02498132
Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
A study testing Behavioral Activation, Cognitvie Based Therapy and Treatment as Usual in people with Depression, run by University of Maryland, College Park.
Trial summary
Elevated depressive symptomatology is a widespread public health concern and individuals with elevated depressive symptoms most frequently report such symptoms to primary care physicians (PCPs). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation, Cognitvie Based Therapy and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be screened by phone. Inclusion criteria:
- Participants must:
- be between the ages of 18 and 65,
- report current elevated depressive symptoms, and
- currently own an iOS-compatible mobile phone.
Who cannot join
- Participants will be excluded if they:
- are currently receiving psychotherapy or psychotropic medication,
- plan to seek psychotherapy within the next 3 months (score > 5 on a self-report 1-10 scale of likelihood to seek treatment),
- endorse current suicidal ideation defined as either
- a response of "I would like to kill myself" or "I would kill myself if I had the chance" on the suicidal thoughts or wishes item of the BDI-II or
- an indication of past month suicidal ideation on the MDD module of the SCID-IV (see Protection of Human Subjects for additional details), or
- meet current diagnostic criteria for MDD; although BA has been used to treat MDD, Moodivate is targeted specifically to elevated symptoms, not major depressive episodes.
About this study
Elevated depressive symptomatology is a widespread public health concern and individuals with elevated depressive symptoms most frequently report such symptoms to primary care physicians (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating elevated depressive symptoms, which results in negative outcomes for their depressed patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The purpose of the proposed project is to\ customize Behavioral Activation (BA), a straightforward, empirically supported treatment for elevated depressive symptoms, for a mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their patients with elevated depressive symptoms.
Read the detailed description
Depressive symptoms are associated with heightened risk of developing major depressive disorder (MDD), significant public health costs, and mortality rates equal to MDD . Individuals experiencing impairment due to depressive symptomatology most frequently report their depressive symptoms to a primary care physician . Despite conflicting data regarding efficacy, PCPs typically prescribe antidepressant medication for the treatment of subthreshold depression and have few other resources at their disposal . The current lack of evidence-based resources available to PCPs for treating depressive symptoms results in a number of negative outcomes for patients including: 1) the majority not receiving appropriate treatment , 2) a decreased likelihood of reporting depressive symptoms again in the future , and 3) heightened mortality risk. As the most likely initial contact for patients with elevated depressive symptoms, PCPs are in a unique position to provide interventions for depression .
Mobile technologies offer an ideal strategy to meet widespread treatment needs. Mobile technologies broadly, and mobile phones more specifically, have dramatically increased in both affordability and ubiquity, with current estimates suggesting that there are over 3.2 billion unique mobile users worldwide . Moreover, the vast majority of physicians report using mobile apps in their clinical practice . Despite these factors supporting the use of mobile apps in clinical practice, there are currently no mobile apps for depressive symptoms available to PCPs that are both evidence-based and simple enough to be recommended to their patients.
One treatment that is particularly amenable to a mobile platform and to referral by PCPs is Behavioral Activation. Across studies, BA is effective for reducing depressive symptoms among individuals with subthreshold depression as well as individuals with MDD and meets the criteria to be established as an empirically support treatment . Moreover, numerous research studies support the superiority of BA as a treatment component to competitor treatments, including Cognitive Behavioral Therapy (CBT) and Cognitive Therapy (CT). The cornerstone of BA is regular self-monitoring to 1) examine already occurring daily activities and 2) facilitate incorporation of new activities consistent with individualized values and goals across life areas. Empirical evidence indicates that mobile customization of BA would work as intended to facilitate reduction of depressive symptomatology, while also addressing the unmet need for evidence-based and easily disseminable resources for use by PCPs with their patients with depressive symptomatology. Moreover, as BA has an evidence-base for smoking cessation, a mobile customization of BA may also hold promise for promoting smoking cessation.
With STTR funding from NIMH, our team is currently completing the development of a self-help BA mobile application named Moodivate for referral by PCPs to their patients with elevated depressive symptoms. App development will be complete by March, 2016 in preparation for a small clinical trial at MUSC. The closest competitor apps for Moodivate are Cognitive Behavioral Therapy (CBT)-based mobile applications. The most popular CBT-based mobile applications include iCouch CBT, Live Happy, MoodPanda, and MoodKit. Of this group of CBT-based mobile applications, MoodKit most closely adheres to standard CBT. As clinical trials of standard BATD frequently compare BATD to CBT, an appropriate analogue of this line of work is to compare Moodivate, a BATD based mobile app, to MoodKit, a CBT based mobile app. Although MoodKit appears to adhere to CBT, no clinical trials to date have been completed examining utilization of MoodKit among individuals with elevated depressive symptoms or among individuals referred by a PCP.
In the current study, we will conduct a small-scale randomized clinical trial with 60 adults with elevated depressive symptoms (Beck Depression Inventory-II (BDI-II) > 14; above the "minimal depression" range on the measure) referred from physicians in the Department of Family Medicine (Drs. Vanessa Diaz and Marty Player) at MUSC. Participants will be randomized to one of three conditions: 1) Moodivate, 2) a Cognitive Behavioral Therapy-based mobile application (MoodKit), or 3) Treatment As Usual (TAU). The purpose of this step is to examine Moodivate treatment feasibility, acceptability, adherence, and change in depressive symptoms associated with Moodivate as compared to MoodKit and TAU. Considering that BA also has an evidence base for smoking cessation, within this group of 60 participants, we plan to recruit 10 participants who are current smokers who will receive Moodivate. Although this will be a small sample of smokers receiving the BA mobile therapy, we believe collecting pilot data examining utilization of Moodivate among a group of smokers will provide valuable insight into the feasibility of utilizing a BA mobile app to promote smoking cessation.
- Conditions
- Depression
- Being tested
- Behavioral Activation, Cognitvie Based Therapy, Treatment as Usual
- Keywords
- Mobile Technologies
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationOther
BA is based in behavioral principles of depression that suggest that depression is caused by a lack of reinforcement in the environment for positive, non-depressed behaviors. As such, the goal of BA is to help the patient reengage in positive, non-depressed activities. In clinical trials, BA as a treatment component has been consistently superior to no treatment and treatment as usual control groups, and a large body of research has found that BA is either equally or more effective than CBT, CT, and antidepressant medications (Cuijpers, Van Straten, \& Warmerdam, 2007; Dimidjian et al., 2006; Jacobson et al., 1996).
Cognitvie Based TherapyOther
CBT explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts, people with mental illness can modify their patterns of thinking to improve coping
Treatment as UsualOther
Individuals will be provided with one on one therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral Activation will be administered via Moodivate will mirror the core BA components outlined above. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist: By eliminating the need for a therapist, we will be able to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms: By eliminating paper forms, we will increase the sensitivity of BA to motivational and organizational deficits frequently observed in patients with elevated depressive symptoms while also increasing treatment fidelity by prompting the patient to complete activities at scheduled times and giving the patient reinforcement for completing activities. Receives: Other: Behavioral Activation |
| Cognitive Based Therapy | Active comparator | Moodkit will be used to administer cognitive based therapy which is commonly compared to behavioral activation. Receives: Other: Cognitvie Based Therapy |
| Treatment as Usual | Active comparator | TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Decrease of Beck Depression Inventory-II Score
The BDI-II is a well-validated tool for the assessment of depressive symptoms and is our key outcome measure. For assessing weekly changes in mood, we will use the Profile of Mood States, a brief self-report scale that has demonstrated satisfactory psychometric properties. For MDD diagnosis, during the phone screening, participants will complete a shortened version of the MDD module of the Structured Clinical Interview for the DSM-IV. The scale for the Beck's Depression Inventory is 0-63 where higher scores indicate more severe depressive symptoms. Scores were analyzed as a 10 point decrease from baseline at any point in the study. For pretreatment, participants completed the BDI-II at baseline and for posttreatment, participants completed the BDI-II 8 weeks after baseline. Values were calculated by subtracting pretreatment from posttreatment and averaging across participants, within treatment condition.
Measured: Baseline and Week 8
Secondary outcomes (12)
Client Treatment Adherence
Client treatment adherence will be measured based on the activity selection and scheduling component of Moodivate.
Measured: Once a week for 8 weeks
Changes Among User Feasibility and Acceptability
User feasibility and acceptability will be assessed both during and following the 8 weeks of Moodivate or MoodKit treatment. During the course of Moodivate or MoodKit treatment, users will be prompted at random intervals to respond to a brief survey online assessing: 1) ease of use of the product, 2) continued desire to use the product, 3) perceived benefits of using the product, and 4) suggestions for product development/modifications for Behavioral Apptivation only). Following the 8 weeks of treatment, participants who were randomized to the Moodivate condition will attend a phone call with the Invesitgator at the Medical University of South Carolina.
Measured: Once a week for 8 weeks
Positive and Negative Affect Schedule (PANAS)
Participants completing the PANAS are asked to rate the extent to which they experienced each out of 20 emotions on a 5-point Likert Scale ranging from "very slightly" to "very much". The exact instructions may vary according to the purpose of the study: Participants may be asked how they feel right now or during longer periods of time (e.g. during the past year). Half of the presented emotion words concern negative affect (distressed, upset, guilty, ashamed, hostile, irritable, nervous, jittery, scared, afraid), the other half positive affect (interested, alert, attentive, excited, enthusiastic, inspired, proud, determined, strong, active). The PANAS is usually regarded as a reliable measure for non-clinical populations
Measured: Once a week for 8 weeks
EROS ( Emotion Regulation of Others and Self)
Assesses strategies used to improve and worsen both one's own and others' emotions. It has two subscales. The intrinsic subscale measures emotion self-regulation using 10 items. The extrinsic subscale measures interpersonal emotion regulation using 9 items.
Measured: Once a week for 8 weeks
Profile of Mood States (POMS)
Measures affective mood states
Measured: Once a week for 8 weeks
Behavioral Activation for Depression Scale (BADS)
The Behavioral Activation for Depression Scale (BADS) can be used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment.
Measured: Once a week for 8 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Assesses anhedonia a core symptom in depression
Measured: Once a week for 8 weeks
Beck Anxiety Inventory (BAI)
21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
Measured: Once a week for 8 weeks
The Addiction Severity Index (ASI) i
The Addiction Severity Index (ASI) is a semi-structured interview for substance abuse assessment and treatment planning. The ASI is designed to gather valuable information about areas of a client's life that may contribute to their substance-abuse problems.
Measured: Once a week for 8 weeks
Fagerstrom Test For Nicotine Dependence (FTND)
The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
Measured: Once a week for 8 weeks
Timeline Followback Method Assessment
The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Measured: Once a week for 8 weeks
Contemplation Ladder
A measure of readiness to consider smoking cessation
Measured: Once a week for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start1 Jun 2016
- Primary completion1 Sep 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNTAINPASS TECHNOLOGY, LLC, Medical University of South Carolina
- Responsible party
- Principal investigator, Joe Smith, University of Maryland, College Park
- Investigators
- Carl Lejuez, Ph.D., Principal investigator, University of Maryland, College ParkJennifer Dahne, MS, Study chair, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498132
- Sponsor's protocol ID
- 1R41MH108219-01
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2015
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kubik MY, Lytle LA, Birnbaum AS, Murray DM, Perry CL. Prevalence and correlates of depressive symptoms in young adolescents. Am J Health Behav. 2003 Sep-Oct;27(5):546-53. doi: 10.5993/ajhb.27.5.6.
PubMed 14521250Cuijpers P, Vogelzangs N, Twisk J, Kleiboer A, Li J, Penninx BW. Differential mortality rates in major and subthreshold depression: meta-analysis of studies that measured both. Br J Psychiatry. 2013 Jan;202(1):22-7. doi: 10.1192/bjp.bp.112.112169.
PubMed 23284149Mitchell AJ, Vaze A, Rao S. Clinical diagnosis of depression in primary care: a meta-analysis. Lancet. 2009 Aug 22;374(9690):609-19. doi: 10.1016/S0140-6736(09)60879-5. Epub 2009 Jul 27.
PubMed 19640579Kessler RC, Demler O, Frank RG, Olfson M, Pincus HA, Walters EE, Wang P, Wells KB, Zaslavsky AM. Prevalence and treatment of mental disorders, 1990 to 2003. N Engl J Med. 2005 Jun 16;352(24):2515-23. doi: 10.1056/NEJMsa043266.
PubMed 15958807Bell RA, Franks P, Duberstein PR, Epstein RM, Feldman MD, Fernandez y Garcia E, Kravitz RL. Suffering in silence: reasons for not disclosing depression in primary care. Ann Fam Med. 2011 Sep-Oct;9(5):439-46. doi: 10.1370/afm.1277.
PubMed 21911763Cuijpers P, de Graaf R, van Dorsselaer S. Minor depression: risk profiles, functional disability, health care use and risk of developing major depression. J Affect Disord. 2004 Apr;79(1-3):71-9. doi: 10.1016/S0165-0327(02)00348-8.
PubMed 15023482McDowell AK, Lineberry TW, Bostwick JM. Practical suicide-risk management for the busy primary care physician. Mayo Clin Proc. 2011 Aug;86(8):792-800. doi: 10.4065/mcp.2011.0076. Epub 2011 Jun 27.
PubMed 21709131Lejuez 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 21324944Gawrysiak, M., Nicholas, C., & Hopko, D. R. (2009). Behavioral activation for moderately depressed university students: Randomized controlled trial. Journal of Counseling Psychology, 56(3), 468-475.
Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.
PubMed 12971122Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck Depression Inventory-II (BDI-II). San Antonio, TX: Psychological Corporation.
McNair, D. M., Lorr, M., & Droppleman, L. F. (1971). Manual for the profile of mood states (POMS). San Diego, CA: Educational and Industrial Testing Services.
First, M., Spitzer, R., Gibbon, M., & Williams, J. (2002). Structured Clinical Interview for DSM-IV Axis IDdisorders: Research Version: Non-patient Edition (SCID-I/NP). New York, NY: Biometrics Research, New York State Psychiatric Insititute.
Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev. 2007 Apr;27(3):318-26. doi: 10.1016/j.cpr.2006.11.001. Epub 2006 Dec 19.
PubMed 17184887Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
PubMed 16881773
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
- ClinicalTrials.gov ID
- NCT02498132
- Acronym / sponsor ID
- 1R41MH108219-01
- Conditions
- Depression
- Keywords
- Mobile Technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- MOUNTAINPASS TECHNOLOGY, LLC, Medical University of South Carolina
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 25 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elevated depressive symptomatology is a widespread public health concern and individuals with elevated depressive symptoms most frequently report such symptoms to primary care physicians (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating elevated depressive symptoms, which results in negative outcomes for their depressed patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The purpose of the proposed project is to\ customize Behavioral Activation (BA), a straightforward, empirically supported treatment for elevated depressive symptoms, for a mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their patients with elevated depressive symptoms.
Detailed description
Depressive symptoms are associated with heightened risk of developing major depressive disorder (MDD), significant public health costs, and mortality rates equal to MDD . Individuals experiencing impairment due to depressive symptomatology most frequently report their depressive symptoms to a primary care physician . Despite conflicting data regarding efficacy, PCPs typically prescribe antidepressant medication for the treatment of subthreshold depression and have few other resources at their disposal . The current lack of evidence-based resources available to PCPs for treating depressive symptoms results in a number of negative outcomes for patients including: 1) the majority not receiving appropriate treatment , 2) a decreased likelihood of reporting depressive symptoms again in the future , and 3) heightened mortality risk. As the most likely initial contact for patients with elevated depressive symptoms, PCPs are in a unique position to provide interventions for depression .
Mobile technologies offer an ideal strategy to meet widespread treatment needs. Mobile technologies broadly, and mobile phones more specifically, have dramatically increased in both affordability and ubiquity, with current estimates suggesting that there are over 3.2 billion unique mobile users worldwide . Moreover, the vast majority of physicians report using mobile apps in their clinical practice . Despite these factors supporting the use of mobile apps in clinical practice, there are currently no mobile apps for depressive symptoms available to PCPs that are both evidence-based and simple enough to be recommended to their patients.
One treatment that is particularly amenable to a mobile platform and to referral by PCPs is Behavioral Activation. Across studies, BA is effective for reducing depressive symptoms among individuals with subthreshold depression as well as individuals with MDD and meets the criteria to be established as an empirically support treatment . Moreover, numerous research studies support the superiority of BA as a treatment component to competitor treatments, including Cognitive Behavioral Therapy (CBT) and Cognitive Therapy (CT). The cornerstone of BA is regular self-monitoring to 1) examine already occurring daily activities and 2) facilitate incorporation of new activities consistent with individualized values and goals across life areas. Empirical evidence indicates that mobile customization of BA would work as intended to facilitate reduction of depressive symptomatology, while also addressing the unmet need for evidence-based and easily disseminable resources for use by PCPs with their patients with depressive symptomatology. Moreover, as BA has an evidence-base for smoking cessation, a mobile customization of BA may also hold promise for promoting smoking cessation.
With STTR funding from NIMH, our team is currently completing the development of a self-help BA mobile application named Moodivate for referral by PCPs to their patients with elevated depressive symptoms. App development will be complete by March, 2016 in preparation for a small clinical trial at MUSC. The closest competitor apps for Moodivate are Cognitive Behavioral Therapy (CBT)-based mobile applications. The most popular CBT-based mobile applications include iCouch CBT, Live Happy, MoodPanda, and MoodKit. Of this group of CBT-based mobile applications, MoodKit most closely adheres to standard CBT. As clinical trials of standard BATD frequently compare BATD to CBT, an appropriate analogue of this line of work is to compare Moodivate, a BATD based mobile app, to MoodKit, a CBT based mobile app. Although MoodKit appears to adhere to CBT, no clinical trials to date have been completed examining utilization of MoodKit among individuals with elevated depressive symptoms or among individuals referred by a PCP.
In the current study, we will conduct a small-scale randomized clinical trial with 60 adults with elevated depressive symptoms (Beck Depression Inventory-II (BDI-II) > 14; above the "minimal depression" range on the measure) referred from physicians in the Department of Family Medicine (Drs. Vanessa Diaz and Marty Player) at MUSC. Participants will be randomized to one of three conditions: 1) Moodivate, 2) a Cognitive Behavioral Therapy-based mobile application (MoodKit), or 3) Treatment As Usual (TAU). The purpose of this step is to examine Moodivate treatment feasibility, acceptability, adherence, and change in depressive symptoms associated with Moodivate as compared to MoodKit and TAU. Considering that BA also has an evidence base for smoking cessation, within this group of 60 participants, we plan to recruit 10 participants who are current smokers who will receive Moodivate. Although this will be a small sample of smokers receiving the BA mobile therapy, we believe collecting pilot data examining utilization of Moodivate among a group of smokers will provide valuable insight into the feasibility of utilizing a BA mobile app to promote smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Other: Behavioral ActivationBehavioral Activation will be administered via Moodivate will mirror the core BA components outlined above. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist: By eliminating the need for a therapist, we will be able to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms: By eliminating paper forms, we will increase the sensitivity of BA to motivational and organizational deficits frequently observed in patients with elevated depressive symptoms while also increasing treatment fidelity by prompting the patient to complete activities at scheduled times and giving the patient reinforcement for completing activities. |
| Cognitive Based Therapy | Active comparator | Other: Cognitvie Based TherapyMoodkit will be used to administer cognitive based therapy which is commonly compared to behavioral activation. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualTAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be between the ages of 18 and 65,
- report current elevated depressive symptoms, and
- currently own an iOS-compatible mobile phone.
Key exclusion criteria (7 listed)
- are currently receiving psychotherapy or psychotropic medication,
- plan to seek psychotherapy within the next 3 months (score > 5 on a self-report 1-10 scale of likelihood to seek treatment),
- endorse current suicidal ideation defined as either
- meet current diagnostic criteria for MDD; although BA has been used to treat MDD, Moodivate is targeted specifically to elevated symptoms, not major depressive episodes.
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 ActivationBA is based in behavioral principles of depression that suggest that depression is caused by a lack of reinforcement in the environment for positive, non-depressed behaviors. As such, the goal of BA is to help the patient reengage in positive, non-depressed activities. In clinical trials, BA as a treatment component has been consistently superior to no treatment and treatment as usual control groups, and a large body of research has found that BA is either equally or more effective than CBT, CT, and antidepressant medications (Cuijpers, Van Straten, \& Warmerdam, 2007; Dimidjian et al., 2006; Jacobson et al., 1996). | Other | Behavioral Activation |
| Cognitvie Based TherapyCBT explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts, people with mental illness can modify their patterns of thinking to improve coping | Other | Cognitive Based Therapy |
| Treatment as UsualIndividuals will be provided with one on one therapy sessions | Other | Treatment as Usual |
Primary outcome
Average Decrease of Beck Depression Inventory-II Score
Time frame: Baseline and Week 8
The BDI-II is a well-validated tool for the assessment of depressive symptoms and is our key outcome measure. For assessing weekly changes in mood, we will use the Profile of Mood States, a brief self-report scale that has demonstrated satisfactory psychometric properties. For MDD diagnosis, during the phone screening, participants will complete a shortened version of the MDD module of the Structured Clinical Interview for the DSM-IV. The scale for the Beck's Depression Inventory is 0-63 where higher scores indicate more severe depressive symptoms. Scores were analyzed as a 10 point decrease from baseline at any point in the study. For pretreatment, participants completed the BDI-II at baseline and for posttreatment, participants completed the BDI-II 8 weeks after baseline. Values were calculated by subtracting pretreatment from posttreatment and averaging across participants, within treatment condition.
12 secondary outcomes
Client Treatment Adherence
Time frame: Once a week for 8 weeks
Changes Among User Feasibility and Acceptability
Time frame: Once a week for 8 weeks
Positive and Negative Affect Schedule (PANAS)
Time frame: Once a week for 8 weeks
EROS ( Emotion Regulation of Others and Self)
Time frame: Once a week for 8 weeks
Profile of Mood States (POMS)
Time frame: Once a week for 8 weeks
Behavioral Activation for Depression Scale (BADS)
Time frame: Once a week for 8 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Once a week for 8 weeks
Beck Anxiety Inventory (BAI)
Time frame: Once a week for 8 weeks
The Addiction Severity Index (ASI) i
Time frame: Once a week for 8 weeks
Fagerstrom Test For Nicotine Dependence (FTND)
Time frame: Once a week for 8 weeks
Timeline Followback Method Assessment
Time frame: Once a week for 8 weeks
Contemplation Ladder
Time frame: Once a week for 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14521250Kubik MY, Lytle LA, Birnbaum AS, Murray DM, Perry CL. Prevalence and correlates of depressive symptoms in young adolescents. Am J Health Behav. 2003 Sep-Oct;27(5):546-53. doi: 10.5993/ajhb.27.5.6.
- Background: PubMed 23284149Cuijpers P, Vogelzangs N, Twisk J, Kleiboer A, Li J, Penninx BW. Differential mortality rates in major and subthreshold depression: meta-analysis of studies that measured both. Br J Psychiatry. 2013 Jan;202(1):22-7. doi: 10.1192/bjp.bp.112.112169.
- Background: PubMed 19640579Mitchell AJ, Vaze A, Rao S. Clinical diagnosis of depression in primary care: a meta-analysis. Lancet. 2009 Aug 22;374(9690):609-19. doi: 10.1016/S0140-6736(09)60879-5. Epub 2009 Jul 27.
- Background: PubMed 15958807Kessler RC, Demler O, Frank RG, Olfson M, Pincus HA, Walters EE, Wang P, Wells KB, Zaslavsky AM. Prevalence and treatment of mental disorders, 1990 to 2003. N Engl J Med. 2005 Jun 16;352(24):2515-23. doi: 10.1056/NEJMsa043266.
- Background: PubMed 21911763Bell RA, Franks P, Duberstein PR, Epstein RM, Feldman MD, Fernandez y Garcia E, Kravitz RL. Suffering in silence: reasons for not disclosing depression in primary care. Ann Fam Med. 2011 Sep-Oct;9(5):439-46. doi: 10.1370/afm.1277.
- Background: PubMed 15023482Cuijpers P, de Graaf R, van Dorsselaer S. Minor depression: risk profiles, functional disability, health care use and risk of developing major depression. J Affect Disord. 2004 Apr;79(1-3):71-9. doi: 10.1016/S0165-0327(02)00348-8.
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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.
Carl Lejuez, Ph.D. principal investigator
University of Maryland, College Park
Jennifer Dahne, MS study chair
University of Maryland, College Park
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation, Cognitvie Based Therapy and Treatment as Usual in people with Depression, run by University of Maryland, College Park.
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 5 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Decrease of Beck Depression Inventory-II Score (time frame: Baseline and 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 NCT02498132, which also lists 16 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 29 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.