N/A N=302 Randomized Single-blind Treatment

Adjusting to Chronic Conditions Using Education, Support, and Skills

Chronic Obstructive Pulmonary Disease · Heart Failure · Anxiety · Depression

Bottom Line

View on ClinicalTrials.gov: NCT01149772 ↗

Enrolled (actual)

302

Serious AEs

5.6%

Results posted

Jan 2016

Primary outcome: Primary: Patient Health Questionnaire -9 (PHQ-9) — 10.35; 13.28; 10.32; 13.49 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ACCESS (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Health Questionnaire -9 (PHQ-9)	10.35; 13.28; 10.32; 13.49; 10.59; 13.22	—
PRIMARY Beck Anxiety Inventory (BAI)	17.42; 22.67; 16.85; 21.59; 16.97; 21.19	—
PRIMARY Chronic Respiratory Questionnaire_Fatigue	3.20; 2.58; 3.11; 2.68; 3.05; 2.77	—
PRIMARY Chronic Respiratory Questionnaire_Mastery	4.25; 3.51; 4.20; 3.45; 3.96; 3.62	—
PRIMARY Chronic Respiratory Questionnaire_Dyspnea	3.37; 2.94; 3.27; 3.03; 3.07; 3.11	—
PRIMARY Kansas City Cardiomyopathy Questionnaire (KCCQ)	40.25; 41.81; 41.34; 36.23; 42.89; 41.68	—

Summary

The current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either the talk-therapy intervention or enhanced usual care. The talk therapy intervention will be provided by VA clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. Enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on COPD and/or HF, depression and anxiety.

Eligibility Criteria

Inclusion Criteria

COPD and/or HF diagnosis; confirmation based upon medical chart review.
clinically significant symptoms for anxiety and/or depression.

Exclusion Criteria

cognitive impairment
presence of bipolar, psychotic or substance abuse disorder.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01149772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.