Depression Clinical Trial
— ACCESSOfficial title:
Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill
Verified date | January 2016 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 302 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | VA Medical Center, Oklahoma City | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Breland JY, Hundt NE, Barrera TL, Mignogna J, Petersen NJ, Stanley MA, Cully JA. Identification of Anxiety Symptom Clusters in Patients with COPD: Implications for Assessment and Treatment. Int J Behav Med. 2015 Oct;22(5):590-6. doi: 10.1007/s12529-014-94 — View Citation
Cully JA, Armento ME, Mott J, Nadorff MR, Naik AD, Stanley MA, Sorocco KH, Kunik ME, Petersen NJ, Kauth MR. Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design. Implement Sci. 2012 Jul — View Citation
Cully JA, Curry AD, Ryan SR, Malik A, Zeno D, Willcockson IU. Development of a computer-aided training program for brief cognitive-behavioral therapy in primary care. Acad Psychiatry. 2013 Mar 1;37(2):120-4. doi: 10.1176/appi.ap.11040078. — View Citation
Hundt NE, Bensadon BA, Stanley MA, Petersen NJ, Kunik ME, Kauth MR, Cully JA. Coping mediates the relationship between disease severity and illness intrusiveness among chronically ill patients. J Health Psychol. 2015 Sep;20(9):1186-95. doi: 10.1177/135910 — View Citation
Mignogna J, Cully J. Depression and Anxiety in Patients with COPD: A Focus on Psychological Treatments in Ambulatory Care Settings. Current respiratory medicine reviews. 2012 Apr 1; 8(2):137-144(8).
Mignogna J, Hundt NE, Kauth MR, Kunik ME, Sorocco KH, Naik AD, Stanley MA, York KM, Cully JA. Implementing brief cognitive behavioral therapy in primary care: A pilot study. Transl Behav Med. 2014 Jun;4(2):175-83. doi: 10.1007/s13142-013-0248-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Health Questionnaire -9 (PHQ-9) | The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | No |
Primary | Beck Anxiety Inventory (BAI) | The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | No |
Primary | Chronic Respiratory Questionnaire_Fatigue | The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health. | 4 month (post treatment), 8 month follow/up, 12 month follow/up | No |
Primary | Chronic Respiratory Questionnaire_Mastery | The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health | 4 month (post treatment), 8 month follow/up, 12 month follow/up | No |
Primary | Chronic Respiratory Questionnaire_Dyspnea | The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health. | 4 month (post treatment), 8 month follow/up, 12 month follow/up | No |
Primary | Kansas City Cardiomyopathy Questionnaire (KCCQ) | The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning. | 4 month (post treatment), 8 month follow/up, and 12 month follow/up | No |
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