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Adjusting to Chronic Conditions Using Education Support and Skills

Improving Quality Of Life For Chronically Ill Patients Using Education Support And Skills; A Randomized Controlled Mental Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00727155
Acronym
ACCESS
Enrollment
3
Registered
2008-08-01
Start date
2008-09-30
Completion date
2009-03-31
Last updated
2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Brief 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. 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.

Interventions

BEHAVIORALAdjusting to Chronic Conditions Using Education Support and Skills

This psychosocial intervention uses a combination of cognitive-behavioral therapy and disease self-management techniques.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18+; 2. Confirmation of CHF or COPD diagnosis according to medical chart review; 3. 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); 4. 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); 5. Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.

Exclusion criteria

1. History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview); 2. 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; 3. Mental status examination score in the cognitively impaired range on an established 6-item screen; 4. Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning); 5. Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.

Design outcomes

Primary

MeasureTime frame
Beck Depression Inventory, State Trait Anxiety Inventory, SF-36 Health SurveyWeeks 1 (baseline), 2, 4, 6, 8, 12, 24, and 36

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026