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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520429

Locations
United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey Cully, PhD MEd BS Houston VA Medical Center
  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:
Chronic Disease
Depression
Depressive Disorder
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Lung Diseases, Obstructive
Mental Disorders
Mood Disorders
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014