VA Home-Based Emotional Learning With Practical Skills

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: CBT

• Registration Number: NCT01685528
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2012-12
• Primary Completion: 2014-05
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT	CBT	-

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder-7	12 weeks
Geriatric Anxiety Inventory	12 weeks
Penn State Worry Questionnaire (PSWQ-A)	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Houston Center for Quality of Care and Utilization Studies; 🇺🇸 Houston, Texas, United States