VA-HELPS: VA Home-Based Emotional Learning With Practical Skills

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01685528
Collaborator
South Central VA Mental Illness Research, Education & Clinical Center (U.S. Fed)
18
1
1
36
0.5

Study Details

Study Description

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
  • Behavioral: CBT
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
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 :
Dec 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Geriatric Anxiety Inventory [12 weeks]

    2. Penn State Worry Questionnaire (PSWQ-A) [12 weeks]

    3. Generalized Anxiety Disorder-7 [12 weeks]

    Secondary Outcome Measures

    1. SF-12 Health Survey [12 weeks]

    2. Brief RCOPE [12 weeks]

      A measure of positive and negative forms of religious coping

    3. Client Satisfaction Questionnaire [12 weeks]

    4. Patient Health Questionnaire-9 [12 weeks]

    5. Geriatric Depression Scale [12 weeks]

    6. Working Alliance Inventory [12 weeks]

    7. Brief Multidimensional Measure of Religiousness and Spirituality [12 weeks]

    8. Insomnia Severity Index [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melinda Stanley, Professor, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT01685528
    Other Study ID Numbers:
    • H-30655
    First Posted:
    Sep 14, 2012
    Last Update Posted:
    Apr 7, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Melinda Stanley, Professor, Baylor College of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2016