Clinical trial NCT01685528: VA Home-Based Emotional Learning With Practical Skills
Official title: VA Home-Based Emotional Learning With Practical Skills (VA-HELPS): Treatment for Depressed and/or Anxious Rural Veterans in Home-Based Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
Geriatric
Veteran
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2012-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and acceptability of providing evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression via telephone to rural Veterans receiving home-based primary care.

Detailed description: VA-HELPS will include flexibility in both content and delivery to meet the needs of Home Based Primary Care (HBPC) Veterans. Content will be modular to meet the needs of both anxious and depressed participants. Modular skills-based treatment has been used successfully with a range of clinical problems (Chorpita et al., 2004; Henin et al., 2001; Wetherell et al., 2009, 2011), including our own group's work treating generalized anxiety disorder (GAD) in primary care (Calleo et al., in press) and anxiety-depression in patients with chronic illness (Cully et al., 2010). To further support a patient-centered treatment approach, patients will have the opportunity to include R/S. Research points to the importance of R/S in coping with illness, with 50-90% of patients reporting using their belief systems to enhance coping skills (Koenig \& Adams, 2008). Along with content modifications, delivery of treatment should complement the needs of HBPC Veterans. Providing one initial in-home session, followed by telephone contact for subsequent sessions, allows cost effectiveness to be taken into consideration; and greater numbers of rural HBPC patients will have access to the intervention.

Treatment will involve approximately 6 to 8 weekly sessions lasting approximately 30-40 minutes each. After the first in-person session, all sessions will be delivered via telephone. At least one booster call (15-20 minutes) will occur during the month following completion of active treatment. All participants will complete assessments at baseline, 8 weeks, and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Part of Home-Based Primary Care
* Reside in a rural community, as defined by the US Census Bureau
* Symptoms of anxiety and/or depression

Exclusion Criteria:

* Significant cognitive impairment
* Active suicidal intent
* Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month

Primary outcomes:
measure: Geriatric Anxiety Inventory
timeFrame: 12 weeks
measure: Penn State Worry Questionnaire (PSWQ-A)
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 12 weeks
Secondary outcomes:
measure: SF-12 Health Survey
timeFrame: 12 weeks
measure: Brief RCOPE
timeFrame: 12 weeks
measure: Client Satisfaction Questionnaire
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9
timeFrame: 12 weeks
measure: Geriatric Depression Scale
timeFrame: 12 weeks
measure: Working Alliance Inventory
timeFrame: 12 weeks
measure: Brief Multidimensional Measure of Religiousness and Spirituality
timeFrame: 12 weeks
measure: Insomnia Severity Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Center for Quality of Care and Utilization Studies
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Melinda A Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References: