AnxietyACCESSNCT00727155
Adjusting to Chronic Conditions Using Education Support and Skills
A study testing Adjusting to Chronic Conditions Using Education Support and Skills in people with Anxiety and Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and are among the least frequent users of mental health services and treatments. 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?
- Adjusting to Chronic Conditions Using Education Support and Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2009
- 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+;
- Confirmation of CHF or COPD diagnosis according to medical chart review;
- Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale [MRC] as obtained by telephone interview);
- Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory - trait subscale (score of 40 or greater);
- Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
Who cannot join
- History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview);
- NYHA class I, or MRC levels 1 and 2. Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms;
- Mental status examination score in the cognitively impaired range on an established 6-item screen;
- Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning);
- Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Quality Of Life For Chronically Ill Patients Using Education Support And Skills; A Randomized Controlled Mental Trial
Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and are among the least frequent users of mental health services and treatments. To address the needs of chronically ill patients, we created a time-limited psychosocial intervention to maximize treatment benefits and improve the efficiency and ability of mental health care practitioners to provide services within medical care settings. This study is separated into two randomized study groups. The first group of participants will receive the ACCESS intervention immediately. The second group of participants will be followed for a period of 6 months. After a period of 6 months, those who continue to have symptoms of depression and/or anxiety will be offered the ACCESS intervention.
- Conditions
- Anxiety, Depression
- Being tested
- Adjusting to Chronic Conditions Using Education Support and Skills
- 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.
Adjusting to Chronic Conditions Using Education Support and SkillsBehavioural
This psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Receives: Behavioral: Adjusting to Chronic Conditions Using Education Support and Skills |
| 2 | No intervention | Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health Survey
Measured: Weeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Jeffrey Cully, PhD MEd, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727155
- Sponsor's protocol ID
- H23264
- Acronym
- ACCESS
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2008
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cully JA, Stanley MA, Deswal A, Hanania NA, Phillips LL, Kunik ME. Cognitive-behavioral therapy for chronic cardiopulmonary conditions: preliminary outcomes from an open trial. Prim Care Companion J Clin Psychiatry. 2010;12(4):PCC.09m00896. doi: 10.4088/PCC.09m00896blu.
PubMed 21085552
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality Of Life For Chronically Ill Patients Using Education Support And Skills; A Randomized Controlled Mental Trial
- ClinicalTrials.gov ID
- NCT00727155
- Acronym / sponsor ID
- ACCESS / H23264
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Aug 2008 (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.
Medically ill patients with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD) are at increased risk for developing symptoms of anxiety and depression and are among the least frequent users of mental health services and treatments. To address the needs of chronically ill patients, we created a time-limited psychosocial intervention to maximize treatment benefits and improve the efficiency and ability of mental health care practitioners to provide services within medical care settings. This study is separated into two randomized study groups. The first group of participants will receive the ACCESS intervention immediately. The second group of participants will be followed for a period of 6 months. After a period of 6 months, those who continue to have symptoms of depression and/or anxiety will be offered the ACCESS intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Adjusting to Chronic Conditions Using Education Support and SkillsTreatment |
| 2 | No intervention | –Waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18+;
- Confirmation of CHF or COPD diagnosis according to medical chart review;
- Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale [MRC] as obtained by telephone interview);
- Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory - trait subscale (score of 40 or greater);
- Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
Key exclusion criteria (5 listed)
- History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview);
- NYHA class I, or MRC levels 1 and 2. Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms;
- Mental status examination score in the cognitively impaired range on an established 6-item screen;
- Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning);
- Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
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 |
|---|---|---|
| Adjusting to Chronic Conditions Using Education Support and SkillsThis psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques. | Behavioural | 1 |
Primary outcome
Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health Survey
Time frame: Weeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36
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 10 Jul 2009.
- Derived from this study: PubMed 21085552Cully JA, Stanley MA, Deswal A, Hanania NA, Phillips LL, Kunik ME. Cognitive-behavioral therapy for chronic cardiopulmonary conditions: preliminary outcomes from an open trial. Prim Care Companion J Clin Psychiatry. 2010;12(4):PCC.09m00896. doi: 10.4088/PCC.09m00896blu.
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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.
Jeffrey Cully, PhD MEd principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjusting to Chronic Conditions Using Education Support and Skills in people with Anxiety and Depression, run by US Department of Veterans Affairs 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 5 inclusion and 5 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 10 Jul 2009. 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?
Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health Survey (time frame: Weeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727155, which also lists 1 linked publication.
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 10 Jul 2009.