VA Home-Based Emotional Learning With Practical Skills

Depression Clinical Trial

— VA-HELPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685528
• Other study ID #: H-30655
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: April 5, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• CBT
6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone

Locations

Country	Name	City	State
United States	Houston Center for Quality of Care and Utilization Studies	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	South Central VA Mental Illness Research, Education & Clinical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geriatric Anxiety Inventory		12 weeks	No
Primary	Penn State Worry Questionnaire (PSWQ-A)		12 weeks	No
Primary	Generalized Anxiety Disorder-7		12 weeks	No
Secondary	SF-12 Health Survey		12 weeks	No
Secondary	Brief RCOPE	A measure of positive and negative forms of religious coping	12 weeks	No
Secondary	Client Satisfaction Questionnaire		12 weeks	No
Secondary	Patient Health Questionnaire-9		12 weeks	No
Secondary	Geriatric Depression Scale		12 weeks	No
Secondary	Working Alliance Inventory		12 weeks	No
Secondary	Brief Multidimensional Measure of Religiousness and Spirituality		12 weeks	No
Secondary	Insomnia Severity Index		12 weeks	No