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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685528
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : April 7, 2016
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Melinda Stanley, 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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: CBT Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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 Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy

Primary Outcome Measures :
  1. Geriatric Anxiety Inventory [ Time Frame: 12 weeks ]
  2. Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: 12 weeks ]
  3. Generalized Anxiety Disorder-7 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. SF-12 Health Survey [ Time Frame: 12 weeks ]
  2. Brief RCOPE [ Time Frame: 12 weeks ]
    A measure of positive and negative forms of religious coping

  3. Client Satisfaction Questionnaire [ Time Frame: 12 weeks ]
  4. Patient Health Questionnaire-9 [ Time Frame: 12 weeks ]
  5. Geriatric Depression Scale [ Time Frame: 12 weeks ]
  6. Working Alliance Inventory [ Time Frame: 12 weeks ]
  7. Brief Multidimensional Measure of Religiousness and Spirituality [ Time Frame: 12 weeks ]
  8. Insomnia Severity Index [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685528

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
Principal Investigator: Melinda A Stanley, PhD Baylor College of Medicine

Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine Identifier: NCT01685528     History of Changes
Other Study ID Numbers: H-30655
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by Melinda Stanley, Baylor College of Medicine:

Additional relevant MeSH terms:
Behavioral Symptoms