N/A
N=52
Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02498132 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Average Decrease of Beck Depression Inventory-II Score — -12.21; -13.36; -7.75 Decrease in units on scale — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation (Other); Cognitvie Based Therapy (Other); Treatment as Usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Decrease of Beck Depression Inventory-II Score |
-12.21; -13.36; -7.75 | <.05 sig |
| SECONDARY Client Treatment Adherence |
46.76 | — |
| SECONDARY Changes Among User Feasibility and Acceptability |
— | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) |
— | — |
| SECONDARY EROS ( Emotion Regulation of Others and Self) |
— | — |
| SECONDARY Profile of Mood States (POMS) |
— | — |
| SECONDARY Behavioral Activation for Depression Scale (BADS) |
— | — |
| SECONDARY Snaith-Hamilton Pleasure Scale (SHAPS) |
— | — |
| SECONDARY Beck Anxiety Inventory (BAI) |
— | — |
| SECONDARY The Addiction Severity Index (ASI) i |
— | — |
| SECONDARY Fagerstrom Test For Nicotine Dependence (FTND) |
— | — |
| SECONDARY Timeline Followback Method Assessment |
— | — |
| SECONDARY Contemplation Ladder |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02498132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.