Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems

NCT02498132 | Completed Results

• 1 other identifier: 1R41MH108219-01
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Depression

Keywords

Mobile Technologies

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 8

Secondary Outcomes (12)

• Client Treatment Adherence

  Once a week for 8 weeks

• Changes Among User Feasibility and Acceptability

  Once a week for 8 weeks

• Positive and Negative Affect Schedule (PANAS)

  Once a week for 8 weeks

• EROS ( Emotion Regulation of Others and Self)

  Once a week for 8 weeks

• Profile of Mood States (POMS)

  Once a week for 8 weeks

Study Arms (3)

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.

Other: Behavioral Activation

Cognitive Based Therapy

ACTIVE COMPARATOR

Moodkit will be used to administer cognitive based therapy which is commonly compared to behavioral activation.

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.

Other: Treatment as Usual

Interventions

Behavioral Activation OTHER

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).

Behavioral Activation

Cognitvie Based Therapy OTHER

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

Cognitive Based Therapy

Treatment as Usual OTHER

Individuals will be provided with one on one therapy sessions

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must:
• be between the ages of 18 and 65,
• report current elevated depressive symptoms, and
• currently own an iOS-compatible mobile phone.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, College Park: lead
• MOUNTAINPASS TECHNOLOGY, LLC: collaborator
• Medical University of South Carolina: collaborator

Related Publications (16)

• 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.

  PMID: 14521250 BACKGROUND

• 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.

  PMID: 23284149 BACKGROUND

• 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.

  PMID: 19640579 BACKGROUND

• 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.

  PMID: 15958807 BACKGROUND

• Bell 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.

  PMID: 21911763 BACKGROUND

• 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.

  PMID: 15023482 BACKGROUND

• 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.

  PMID: 21709131 BACKGROUND

• 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.

  PMID: 21324944 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12971122 BACKGROUND

• Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck Depression Inventory-II (BDI-II). San Antonio, TX: Psychological Corporation.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17184887 BACKGROUND

• 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.

  PMID: 16881773 BACKGROUND

• Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996 Apr;64(2):295-304. doi: 10.1037//0022-006x.64.2.295.

  PMID: 8871414 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Professor Carl Lejuez
• Organization: University of Kansas

clejuez@ku.edu

240-535-0467

Study Officials

• Carl Lejuez, Ph.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Jennifer Dahne, MS

  University of Maryland, College Park

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - HRPP (C. Lejuez is no longer at UMD)

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 15, 2015
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 31, 2016
• Last Updated: November 29, 2023
• Results First Posted: February 25, 2022

Record last verified: 2023-11