VA Home-Based Emotional Learning With Practical Skills

NCT ID: NCT01685528

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT

Group Type: EXPERIMENTAL

CBT

Intervention Type: BEHAVIORAL

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

Interventions

CBT

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Behavior Treatment, Cognitive Behavior Therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Central VA Mental Illness Research, Education & Clinical Center

FED

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Melinda Stanley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda A Stanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, United States

Countries

United States

Other Identifiers

H-30655

Identifier Type: -

Identifier Source: org_study_id