Transforming Psychotherapy for Chronically Ill Patients

NCT00520429 | Completed Phase 1

• 1 other identifier: MIRECC001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure, Congestive; Pulmonary Disease, Chronic Obstructive; Depression; Anxiety

Keywords

Depression; Anxiety; Pulmonary Disease, Chronic Obstructive; Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessments at baseline, post treatment, and 3 month follow-up.

Secondary Outcomes (1)

• 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.

  Assessments at baseline, post treatment, and 3 month follow-up.

Study Arms (1)

1

OTHER

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

Interventions

ACCES - Adjusting to Chronic Conditions with Education and Support BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Houston VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Depression; Anxiety Disorders

Interventions

Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeffrey Cully, PhD MEd BS

  Michael E. DeBakey VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 7, 2009

Record last verified: 2008-07

Locations

US (1)