VA Home-Based Emotional Learning With Practical Skills (VA-HELPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: CBT

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Center for Quality of Care and Utilization Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Insomnia Severity Index		12 weeks
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: South Central VA Mental Illness Research, Education & Clinical Center
• Investigators: Principal Investigator: Melinda A Stanley, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Veteran; Geriatric
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: H-30655