Clinical trial NCT01891734: Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology
Official title: Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Anxiety
Keywords: Veterans
Health Services
Mental Health
Technology
Primary Health Care
Psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-07-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Access and engagement in evidence-based psychotherapies for Veterans are high priorities for the Veterans Health Administration, especially the Office of Rural Health and the office of Mental Health Services. SmartPhone applications are an emerging technology with a vast potential to extend the reach of traditional in-person psychotherapy by allowing increased digital access to providers and self-management tools. Due to the relatively recent development of this technology, there are no data on the effectiveness of SmartPhone-delivered psychotherapy. Preliminary data on acceptability and satisfaction are promising, suggesting a need for further research. The National Center for Posttraumatic Stress Disorder in collaboration with the National Center for Telehealth \& Technology (T2) recently completed the development of an app called Moving Forward, a Veteran-friendly adaptation of Problem Solving Therapy, an evidence based therapy available through Primary Care Integration Clinics. In partnership with Mental Health Services, this proposed pilot project will gather preliminary data on the effectiveness and acceptability of Moving Forward and provide timely feedback to the app creators. Participants will include approximately 40 Veterans diagnosed with an anxiety or mood disorder interested in obtaining mental health treatment in Primary Care -Mental Health Integration. Participants will be randomly assigned to receive either Problem Solving Therapy augmented by the Moving Forward app or Problem Solving Therapy alone. Participants will complete assessments at baseline, 6 weeks and 12 weeks. Investigators propose 3 specific hypotheses. In hypothesis 1, investigators predict a moderate effect size will be observed when comparing homework completion and satisfaction for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone. In hypothesis 2, investigators predict a moderate effect size will be observed when comparing change scores on the problem solving style for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone. In hypothesis 3, investigators predict a moderate effect size will be observed when comparing depression, anxiety, stress and quality of life change for patients randomized to Problem Solving Therapy plus the Moving Forward app compared to patients randomized to Problem Solving Therapy alone. Key informant interviews will provide qualitative feedback on the Moving Forward app which investigators will share with our partners at Mental Health Services. The proposed project is important to the VA mission to improve access for all Veterans particularly those who face barriers to engagement in traditional face-to-face treatment. The proposed research addresses one of three primary focus areas of the Office of Research and Development (Access), two of Health Services Research \&Development's research priorities (Access/Rural Health and Mental Health), and three of Secretary Shinseki's Transformational Initiatives for the 21st Century including improving: 1) access to care, 2) mental health, and 3) patient-centeredness. This proposed work is innovative as it focuses on a rapidly emerging mobile technology that has great potential to improve access and engagement in mental health service delivery. To date, there have been no randomized effectiveness trials that have examined SmartPhone apps for mental health service delivery. The project is also timely as there is a temporary moratorium (imposed by the Office of Information Technology) on app dissemination within Veterans Health Administration, presenting an opportunity to study Moving Forward prior to its release. At the completion of this project, investigators expect that the work proposed in this study will highlight the clinical value of the Moving Forward app, which will inform both VA policy makers and the scientific community at large about the utility of SmartPhone technology in mental health care delivery. Investigators also expect that this study will provide our partners at Mental Health Services with helpful feedback on the Moving Forward app design and future app development.

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.

Primary outcomes:
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: 6 weeks, 12 weeks
Secondary outcomes:
measure: Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
timeFrame: 6 weeks, 12 weeks
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Kathleen M Grubbs, PhD
role: PRINCIPAL_INVESTIGATOR
References: