VA Home-Based Emotional Learning With Practical Skills

Study Overview
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Brief Summary
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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
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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.

Official Title
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VA Home-Based Emotional Learning With Practical Skills (VA-HELPS): Treatment for Depressed and/or Anxious Rural Veterans in Home-Based Primary Care

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br> | Behavioral: CBT<br>* 6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone<br>* Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Anxiety Inventory |  | 12 weeks | 
| Penn State Worry Questionnaire (PSWQ-A) |  | 12 weeks | 
| Generalized Anxiety Disorder-7 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 Health Survey |  | 12 weeks | 
| Brief RCOPE | A measure of positive and negative forms of religious coping | 12 weeks | 
| Client Satisfaction Questionnaire |  | 12 weeks | 
| Patient Health Questionnaire-9 |  | 12 weeks | 
| Geriatric Depression Scale |  | 12 weeks | 
| Working Alliance Inventory |  | 12 weeks | 
| Brief Multidimensional Measure of Religiousness and Spirituality |  | 12 weeks | 
| Insomnia Severity Index |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression, Geriatric, Veteran