Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01572389
First received: March 7, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.


Condition Intervention Phase
Diabetes Mellitus
Depression
Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)
Behavioral: Enhanced Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Hemoglobin A1C during intervention [ Time Frame: Hemoglobin A1C levels will be measured between baseline and 6 months. ] [ Designated as safety issue: No ]
    Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.


Secondary Outcome Measures:
  • Change in Diabetes specific quality of life during intervention [ Time Frame: Diabetes specific quality of life will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in Hemoglobin A1C during maintenance phase [ Time Frame: Hemoglobin A1C levels will be measured between 6 months and 12 months. ] [ Designated as safety issue: No ]
    Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.

  • Change in Patient Health Questionnaires-9 during intervention [ Time Frame: PHQ-9 will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention.

  • Change in Patient Health Questionnaires-9 during maintenance phase [ Time Frame: PHQ-9 will be assessed between 6 months and 12 months. ] [ Designated as safety issue: No ]
    The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the maintenance phase.

  • Change in Diabetes specific quality of life during maintenance phase [ Time Frame: Diabetes specific quality of life will be measured between 6 and 12 months post-intervention. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in self-efficacy during intervention [ Time Frame: Self-efficacy will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in self-efficacy during maintenance phase [ Time Frame: Self-efficacy will be assessed between 6 months and 12 months post-intervention. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in medication adherence during intervention. [ Time Frame: Medication adherence will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in medication adherence during maintenance phase [ Time Frame: Medication adherence will be assessed between 6 months and 12 months post-intervention. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in self management behavior during intervention [ Time Frame: Self management behavior will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in self management behavior during maintenance phase [ Time Frame: Self management behavior will be assessed between 6 months and 12 months post-intervention. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in anxiety scores during intervention [ Time Frame: Anxiety scores will be assessed between baseline and 6 months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in anxiety scores during maintenance phase [ Time Frame: Anxiety scores will be assessed between 6 months and 12 months post-intervention. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.


Estimated Enrollment: 242
Study Start Date: November 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.
Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)
HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.
Active Comparator: Arm 2
The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.
Behavioral: Enhanced Usual Care
All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
  • as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers

Participants must have:

  • a diagnosis of diabetes mellitus
  • an average HbA1c level >7.5% in the prior 6 months
  • clinically significant symptoms of depression
  • Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
  • To verify that participants meet the depression criteria, we will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.

Exclusion Criteria:

  • We will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
  • Specific exclusion criteria are:

    • lack of regular access to a telephone
    • significant cognitive impairment (three or more errors) on an established six-item screening exam
    • meeting criteria for bipolar, psychotic, or substance-abuse disorders
    • presence of uncorrected hearing or vision impairment
    • their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
    • they live within 20 miles of the MEDVAMC.
  • Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
  • Patients receiving mental health services at the time of study recruitment will not be excluded.
  • All mental health treatments and health service-use characteristics will be included in study analyses as covariates.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572389

Contacts
Contact: Aanand D Naik, MD (713) 794-8541 Aanand.Naik@va.gov
Contact: Jeffrey Cully, PhD MEd (713) 794-8526 jeffrey.cully@va.gov

Locations
United States, Texas
Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Darrell Zeno, MS BS    (713) 794-8678    darrell.zeno@va.gov   
Contact: Shannon D Underwood, BA    (713) 794-8621    shannon.underwood@va.gov   
Principal Investigator: Aanand Dinkar Naik, MD         
Principal Investigator: Jeffrey Cully, PhD MEd         
Sub-Investigator: Mark E. Kunik, MD MPH         
Sub-Investigator: Nicholas Masozera, MD         
Sub-Investigator: Radha Rao, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Aanand Dinkar Naik, MD Michael E DeBakey VA Medical Center
Principal Investigator: Jeffrey Cully, PhD MEd Michael E DeBakey VA Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01572389     History of Changes
Other Study ID Numbers: IIR 10-135, IIR 10-135
Study First Received: March 7, 2012
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
Depression
Affective Symptoms
Self Care
Telemedicine
Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014