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Completed

NCT Number: NCT01685528

VA Home-Based Emotional Learning With Practical Skills

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • South Central VA Mental Illness Research, Education & Clinical Center

Registry information

Official study title

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

Acronym: VA-HELPS

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 14, 2012
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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