Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology

NCT01891734 | Completed Phase 1 Results

• 1 other identifier: PPO 13-122
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Veterans; Health Services; Mental Health; Technology; Primary Health Care; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety and Stress Scale (DASS)

  The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.

  6 weeks, 12 weeks

Secondary Outcomes (2)

• Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score

  6 weeks, 12 weeks

• Client Satisfaction Questionnaire (CSQ-8)

  6 weeks

Study Arms (2)

Problem Solving Therapy plus Moving Forward (PST-MF)

EXPERIMENTAL

All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu \& D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website. The phone content matches Problem Solving Therapy. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.

Other: Problem Solving Therapy plus Moving Forward

Problem Solving Therapy

ACTIVE COMPARATOR

All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu \& D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.

Other: Problem Solving Therapy

Interventions

Problem Solving Therapy plus Moving Forward OTHER

All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu \& D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website. The phone content matches Problem Solving Therapy. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.

Problem Solving Therapy plus Moving Forward (PST-MF)

Problem Solving Therapy OTHER

All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu \& D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.

Problem Solving Therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Results Point of Contact

• Title: Kathleen Grubbs
• Organization: Department of Veterans Affairs San Diego

kathleen.grubbs@va.gov

808-383-9757

Study Officials

• Kathleen M Grubbs, PhD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 3, 2013
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 28, 2016
• Results First Posted: September 16, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)