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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01685528
First received: September 12, 2012
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Anxiety
Depression
Behavioral: CBT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Geriatric Anxiety Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder-7 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12 Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brief RCOPE [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A measure of positive and negative forms of religious coping

  • Client Satisfaction Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire-9 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Working Alliance Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brief Multidimensional Measure of Religiousness and Spirituality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT Behavioral: CBT
6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone
Other Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685528

Locations
United States, Texas
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
South Central VA Mental Illness Research, Education & Clinical Center
Investigators
Principal Investigator: Melinda A Stanley, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01685528     History of Changes
Other Study ID Numbers: H-30655
Study First Received: September 12, 2012
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Anxiety
Depression
Geriatric
Veteran

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 24, 2014