Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

This study is currently recruiting participants.
Verified December 2013 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: December 24, 2013
Last verified: December 2013

March 7, 2012
December 24, 2013
November 2012
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01572389 on ClinicalTrials.gov Archive Site
  • 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.
  • Diabetes specific quality of life; self-efficacy; medication adherence; self management behavior adherence; anxiety scores [ Time Frame: All secondary measures will be taken at baseline, 6 months and 12 months post intervention. ] [ Designated as safety issue: No ]
    Measures are 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 duign 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 duign 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.
Not Provided
Not Provided
 
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

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.

Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health.

Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up.

Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC.

Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants.

Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility-level factors (availability of medical and mental health services by clinical site).

Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a.

Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the RE-AIM framework for evaluating effectiveness of behavioral interventions.

Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC.

Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral coaches, patients' use of action plans, and responses to coaches' recommendations in preparation for future implementation

Project Methods: 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 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants' primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Diabetes Mellitus
  • Depression
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)
  • 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.
    Intervention: Behavioral: Enhanced Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
242
March 2016
December 2015   (final data collection date for primary outcome measure)

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) a diagnosis of diabetes mellitus
  • (b) an average HbA1c level >7.5% in the prior 6 months
  • (c) 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:

    • (a) lack of regular access to a telephone
    • (b) significant cognitive impairment (three or more errors) on an established six-item screening exam
    • (c) meeting criteria for bipolar, psychotic, or substance-abuse disorders
    • (d) presence of uncorrected hearing or vision impairment
    • (e) their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
    • (f) 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.
Both
18 Years and older
No
Contact: Aanand D Naik, MD (713) 794-8541 Aanand.Naik@va.gov
Contact: Jeffrey Cully, PhD MEd (713) 794-8526 jeffrey.cully@va.gov
United States
 
NCT01572389
IIR 10-135
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Aanand Dinkar Naik, MD Michael E DeBakey VA Medical Center
Principal Investigator: Jeffrey Cully, PhD MEd Michael E DeBakey VA Medical Center
Department of Veterans Affairs
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP