Completed

VA-HELPSHome-Based Emotional Learning for Depressed and Anxious Rural Veterans in Primary Care

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Study Aim

This study aims to provide home-based emotional learning as a treatment for rural veterans experiencing depression and anxiety, with the primary outcomes measuring anxiety levels using the Geriatric Anxiety Inventory, Penn State Worry Questionnaire, and Generalized Anxiety Disorder-7.

What is being tested

CBT

Behavioral
Who is being recruted

Behavior+2

+ Mental Disorders

+ Behavioral Symptoms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: April 7, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorBaylor College of Medicine
Last updated: April 7, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsAnxiety DisordersDepression

Criteria

4 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
Active suicidal intent

Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month

Significant cognitive impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Houston Center for Quality of Care and Utilization Studies

Houston, United StatesOpen Houston Center for Quality of Care and Utilization Studies in Google Maps
CompletedOne Study Center