CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 302 enrolled
Drug / intervention
ACCESSbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01149772
NCT01149772N/ACompleted

Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill

VA Office of Research and Development·interventional·Posted Jun 23, 2010·Updated Feb 24, 2016

In Brief

A clinical study evaluating ACCESS for Chronic Obstructive Pulmonary Disease and 3 related conditions. Completed, enrolled 302 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2010
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.0 years ago

Interventions

ACCESSbehavioral

Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. Participants also had the option to receive 2 brief follow-up booster calls to aid in reinforcing the changes made.