Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
NCT ID: NCT02498132
Last Updated: 2023-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2016-06-01
2016-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Behavioral Activation
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.
Behavioral Activation
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).
Cognitive Based Therapy
Moodkit will be used to administer cognitive based therapy which is commonly compared to behavioral activation.
Cognitvie Based Therapy
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 Usual
TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application.
Treatment as Usual
Individuals will be provided with one on one therapy sessions
Interventions
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Behavioral Activation
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 Therapy
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 Usual
Individuals will be provided with one on one therapy sessions
Eligibility Criteria
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Inclusion Criteria
1. be between the ages of 18 and 65,
2. report current elevated depressive symptoms, and
3. currently own an iOS-compatible mobile phone.
Exclusion Criteria
1. are currently receiving psychotherapy or psychotropic medication,
2. plan to seek psychotherapy within the next 3 months (score \> 5 on a self-report 1-10 scale of likelihood to seek treatment),
3. endorse current suicidal ideation defined as either
1. 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
2. an indication of past month suicidal ideation on the MDD module of the SCID-IV (see Protection of Human Subjects for additional details), or
4. 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.
18 Years
65 Years
ALL
Yes
Sponsors
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MOUNTAINPASS TECHNOLOGY, LLC
UNKNOWN
Medical University of South Carolina
OTHER
University of Maryland, College Park
OTHER
Responsible Party
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Joe Smith
Director - HRPP (C. Lejuez is no longer at UMD)
Principal Investigators
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Carl Lejuez, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, College Park
Jennifer Dahne, MS
Role: STUDY_CHAIR
University of Maryland, College Park
References
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Cuijpers 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.
Mitchell 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.
Kessler 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.
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Cuijpers 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.
McDowell 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.
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.
Gawrysiak, 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.
Beck, 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.
Dimidjian 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.
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Other Identifiers
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