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Phase 2 Completed N=33 Randomized Health Services Research

Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology

Source: ClinicalTrials.gov NCT01891734 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Depression Anxiety and Stress Scale (DASS) — 6.14; 5.23; 7.21; 5.62 units on a scale

Summary

This project will be the first to evaluate the Moving Forward app in VA. Identifying an effective treatment for anxiety and depression in primary care is imperative within Veterans Health Administration as they are both common, chronic, and debilitating conditions associated with a number of personal and health-related costs. In close partnership with app developers at Mental Health Services, a major contribution of this research is the actionable feedback on the acceptability, feasibility and effectiveness of augmenting traditional Problem Solving Therapy with the Moving Forward app for future app development. If effectiveness can be established, Moving Forward has the potential for integration into the larger continuum of care for depression and anxiety in Primary Care-Mental Health Integration (e.g., care management, co-located collaborative care). Lastly, this pilot project will provide preliminary data for future research on SmartPhone technology. Veteran feedback on treatment components, ease of executing the study successfully and preliminary effect size calculations, will inform the design of the larger project.

Outcome Measures

OutcomeResultp-value
PRIMARY
Depression Anxiety and Stress Scale (DASS)
6.14; 5.23; 7.21; 5.62; 11.29; 8.23
SECONDARY
Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
40.00; 37.19; 39.92; 40.15 <0.05 sig
SECONDARY
Client Satisfaction Questionnaire (CSQ-8)
27.87; 29.06 <0.05 sig

Eligibility Criteria

Inclusion Criteria

  • Veterans will be eligible if they are 18 years old or older,
  • speak and understand English,
  • are patients in the Central Arkansas Veterans Healthcare System Primary Care-Mental Health Integration,
  • and have a current diagnosis of depression
  • major depressive disorder, 296.2x and 296.3x
  • dysthymic disorder, 300.4
  • depressive disorder not otherwise specified, 311
  • and/or anxiety
  • panic disorder without agoraphobia, 300.01
  • panic disorder with agoraphobia, 300.21
  • specific phobia, 300.29
  • social phobia, 300.23
  • obsessive-compulsive disorder; 300.3
  • posttraumatic stress disorder, 309.81
  • acute stress disorder, 308.3
  • generalized anxiety disorder, 300.02
  • anxiety disorder not otherwise specified, 300.00
  • We considered enrolling only those Veterans diagnosed with mild-to-moderate depression, but chose to include a range of anxiety and depression-related disorders in order to reflect the population of Veterans seen in Primary Care-Mental Health Integration.
  • Additionally, Problem Solving Therapy is designed to treat a range of stress-related problems, including both anxiety and depressive disorders.
  • Veterans taking prescribed anxiolytics or anti-depressants will be eligible if they are on a stable medication regimen.

Exclusion Criteria

  • Exclusionary criteria include any current suicidal ideation,
  • substance dependence diagnosis and current use,
  • any psychotic spectrum diagnoses or
  • inability to provide informed consent.
  • Diagnosis will be confirmed by chart review and Mini International Neuropsychiatric Interview.
  • Acute suicidal ideation will be determined by the assessing or treating clinician.
  • During the baseline and follow-up interviews, any Veteran who endorses a "1" or higher on item # 21 on the Depression Anxiety and Stress Scale "I feel that life isn't worthwhile" or item # 9 on the Patient Health Questionnaire-9 "thoughts that you would be better off dead or of hurting yourself" will be asked follow-up questions on the suicide risk protocol (see appendix 3).
  • Current substance or alcohol use will be determined by the alcohol and substance use modules of the Mini International Neuropsychiatric Interview.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01891734). 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. Informational only — not medical advice.

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