AnxietyVA-HELPSNCT01685528
VA Home-Based Emotional Learning With Practical Skills
A study testing CBT in people with Anxiety and Depression, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant cognitive impairment
- Active suicidal intent
- Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, 77030
About this study
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
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.
Read the 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
- Being tested
- CBT
- Keywords
- Anxiety, Depression, Geriatric, Veteran
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called Cognitive Behavior Treatment, Cognitive Behavior Therapy
6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Anxiety Inventory
Measured: 12 weeks
Penn State Worry Questionnaire (PSWQ-A)
Measured: 12 weeks
Generalized Anxiety Disorder-7
Measured: 12 weeks
Secondary outcomes (8)
SF-12 Health Survey
Measured: 12 weeks
Brief RCOPE
A measure of positive and negative forms of religious coping
Measured: 12 weeks
Client Satisfaction Questionnaire
Measured: 12 weeks
Patient Health Questionnaire-9
Measured: 12 weeks
Geriatric Depression Scale
Measured: 12 weeks
Working Alliance Inventory
Measured: 12 weeks
Brief Multidimensional Measure of Religiousness and Spirituality
Measured: 12 weeks
Insomnia Severity Index
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Responsible party
- Principal investigator, Melinda Stanley, Baylor College of Medicine
- Investigators
- Melinda A Stanley, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685528
- Sponsor's protocol ID
- H-30655
- Acronym
- VA-HELPS
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2012
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01685528
- Acronym / sponsor ID
- VA-HELPS / H-30655
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, Geriatric, Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Significant cognitive impairment
- Active suicidal intent
- Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTAlso: Cognitive Behavior Treatment, Cognitive Behavior Therapy6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone | Behavioural | CBT |
Primary outcome
Geriatric Anxiety Inventory
Time frame: 12 weeks
Penn State Worry Questionnaire (PSWQ-A)
Time frame: 12 weeks
Generalized Anxiety Disorder-7
Time frame: 12 weeks
8 secondary outcomes
SF-12 Health Survey
Time frame: 12 weeks
Brief RCOPE
Time frame: 12 weeks
Client Satisfaction Questionnaire
Time frame: 12 weeks
Patient Health Questionnaire-9
Time frame: 12 weeks
Geriatric Depression Scale
Time frame: 12 weeks
Working Alliance Inventory
Time frame: 12 weeks
Brief Multidimensional Measure of Religiousness and Spirituality
Time frame: 12 weeks
Insomnia Severity Index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda A Stanley, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Anxiety and Depression, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Anxiety Inventory (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.