Transforming Psychotherapy for Chronically Ill Patients
This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00520429
First received: August 23, 2007
Last updated: January 5, 2009
Last verified: July 2008
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Purpose
The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive Pulmonary Disease, Chronic Obstructive Depression Anxiety |
Behavioral: ACCES - Adjusting to Chronic Conditions with Education and Support |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transforming Psychotherapy for Chronically Ill Patients |
Resource links provided by NLM:
MedlinePlus related topics:
Anxiety
COPD (Chronic Obstructive Pulmonary Disease)
Depression
Heart Failure
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- State-trait Anxiety Inventory (STAI), a 40-item self-report measure of anxiety symptoms.Beck Depression Inventory-II (BDI-II), assessing 21 depression symptoms. Client Satisfaction Questionnaire (CSQ), an 8-item, empirical, self-report measure. [ Time Frame: Assessments at baseline, post treatment, and 3 month follow-up. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item self-report measure of constructs. Chronic Respiratory Questionnaire (CRQ), measuring QoL change over time in COPD patients. Short Form 36 (SF-36), a generic measure of health-related QoL. [ Time Frame: Assessments at baseline, post treatment, and 3 month follow-up. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 23 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
This study is an open pilot; therefore all participants were given the opportunity to receive treatment.
|
Behavioral: ACCES - Adjusting to Chronic Conditions with Education and Support
The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 (score of 40 or greater)
- Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
Exclusion Criteria:
- History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from chart review and 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cully, Jeffrey - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00520429 History of Changes |
| Other Study ID Numbers: | MIRECC001 |
| Study First Received: | August 23, 2007 |
| Last Updated: | January 5, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Depression Anxiety Pulmonary Disease, Chronic Obstructive Heart Failure, Congestive |
Additional relevant MeSH terms:
|
Anxiety Disorders Chronic Disease Depression Depressive Disorder Heart Failure Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Mental Disorders |
Disease Attributes Pathologic Processes Behavioral Symptoms Mood Disorders Heart Diseases Cardiovascular Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 19, 2013