Adjusting to Chronic Conditions Using Education, Support, and Skills

NCT01149772 | Completed Results DMC

• 2 other identifiers: IIR 09-0882619
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Heart Failure; Anxiety; Depression

Keywords

Chronic Obstructive Pulmonary Disease; Heart Failure; Anxiety; Depression

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

ACCESS

EXPERIMENTAL

Medically ill patients received six-sessions of cognitive behavioral therapy tailored to their unique needs. Patients received 2 core modules and 3 elective modules. Elective modules focused on physical health, cognitive restructuring, behavioral activation, and relaxation. The six session was a wrap up that everyone received. Patients also had the option to receive 2 follow-up booster sessions to aid in maintenance of skills learned.

Behavioral: ACCESS

Enhanced Usual Care

NO INTERVENTION

Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.

Interventions

ACCESS BEHAVIORAL

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.

ACCESS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (11)

• 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.

  PMID: 24904701 RESULT

• 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. No abstract available.

  PMID: 23475245 RESULT

• 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 11;7:64. doi: 10.1186/1748-5908-7-64.

  PMID: 22784436 RESULT

• 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).

  RESULT

• 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: 10.1177/1359105313509845. Epub 2013 Dec 1.

  PMID: 24296739 RESULT

• 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/s12529-014-9450-2.

  PMID: 25622813 RESULT

• Hundt NE, Renn BN, Sansgiry S, Petersen NJ, Stanley MA, Kauth MR, Naik AD, Kunik ME, Cully JA. Predictors of response to brief CBT in patients with cardiopulmonary conditions. Health Psychol. 2018 Sep;37(9):866-873. doi: 10.1037/hea0000595.

  PMID: 30138022 DERIVED

• Mignogna J, Martin LA, Harik J, Hundt NE, Kauth M, Naik AD, Sorocco K, Benzer J, Cully J. "I had to somehow still be flexible": exploring adaptations during implementation of brief cognitive behavioral therapy in primary care. Implement Sci. 2018 Jun 5;13(1):76. doi: 10.1186/s13012-018-0768-z.

  PMID: 29866141 DERIVED

• Renn BN, Hundt NE, Sansgiry S, Petersen NJ, Kauth MR, Kunik ME, Cully JA. Integrated Brief Cognitive Behavioral Therapy Improves Illness Intrusiveness in Veterans With Chronic Obstructive Pulmonary Disease. Ann Behav Med. 2018 Jul 13;52(8):686-696. doi: 10.1093/abm/kax045.

  PMID: 29860524 DERIVED

• Thakur ER, Sansgiry S, Petersen NJ, Stanley M, Kunik ME, Naik AD, Cully JA. Cognitive and Perceptual Factors, Not Disease Severity, Are Linked with Anxiety in COPD: Results from a Cross-Sectional Study. Int J Behav Med. 2018 Feb;25(1):74-84. doi: 10.1007/s12529-017-9663-2.

  PMID: 28779469 DERIVED

• Cully JA, Stanley MA, Petersen NJ, Hundt NE, Kauth MR, Naik AD, Sorocco K, Sansgiry S, Zeno D, Kunik ME. Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial. J Gen Intern Med. 2017 Sep;32(9):1014-1024. doi: 10.1007/s11606-017-4101-3. Epub 2017 Jun 20.

  PMID: 28634906 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

There were some deaths and hospitalizations during the study, however, none of the adverse events reported were determined to be related to the study.

Results Point of Contact

• Title: Dr. Jeffrey Cully
• Organization: Michael E. DeBakey VA Medical Center

Jeffrey.Cully@va.gov

713-794-8526

Study Officials

• Jeffrey Cully, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 23, 2010
• Study Start: February 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: January 18, 2016

Record last verified: 2016-01

Locations

US (2)