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Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02057042
First received: January 7, 2014
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).

Condition Intervention
Depression Behavioral: Peer-assisted computerized CBT Behavioral: Enhanced usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • functional status [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Functional status will be measured using the Veterans RAND 36-Item Health Survey (VR-36), formerly called the Short-Form 36 for Veterans. This is a measure of functional status adapted from the Medical Outcomes Study Short Form-36 for use among Veterans. The measure assesses physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), energy/vitality (V), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The VR-36 has somewhat greater precision at the lower end of the health status continuum than the SF-36. The VR-36 has been used in numerous prior VA focused studies.

  • depression symptoms [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Depressive symptoms will be measured with the Beck Depression Inventory (BDI-II) at baseline, 3 months post intervention and 6 months post intervention. The BDI-II is a 21-item self-report instrument for measuring the severity of depression among individuals aged 13 years and older. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 63. The BDI has been widely used and shows acceptable reliability, with Cronbach's in the range of 0.81-0.86.

  • recovery orientation [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales.

  • Quality of Life [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR*D study.


Secondary Outcome Measures:
  • depression coping [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Depression coping will be assessed with the Depression Coping Self-Efficacy Scale (DCSES). The DCSES is a 24-item, self-report rating scale used to assess the coping self-efficacy of psychiatric patients with depression. Items include depression management tasks and techniques related to activity level, tension, interpersonal behavior, problem-solving, thought reformulation, and sleep patterns. Individuals respond to each item using a probability scale, in which they numerically rate their confidence in their abilities to perform each task. This measure has demonstrated to have good reliability, with a Cronbach's of .93, and subsequent studies have provided support for the construct, concurrent, and discriminant validities of the DCSES.

  • antidepressant adherence [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    We will construct medication possession ratios for antidepressants prescribed for the 3 months following enrollment and for 3-6 months following enrollment. In addition to pharmacy data, The Brief Medication Questionnaire will also be used to assess adherence and may be particularly helpful if patients receive some antidepressant medication fills outside of the VA. It has been validated using Medication Event Monitoring System (MEMS) caps and found to be 80-100% sensitive for repeat non-adherence and 90% sensitive for sporadic non-adherence.

  • Cognitive Behavioral Therapy Skills [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    CBT skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ). The CBTSQ is a 16-item scale consisting of two factors, Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms.

  • initiation and completion of traditional psychotherapy [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Receipt of VA and non-VA Traditional In-Person Psychotherapy: We will review enrolled patients' VA medical record notes to determine their receipt of any traditional in-person psychotherapy and their completion of 8 in-person psychotherapy visits within 3 and 6 months following enrollment. We will also assess whether the Veteran received psychotherapy that was depression focused and evidence-based, assessing the presence of key phrases in notes that denote CBT, Acceptance and Commitment Therapy (ACT), or Interpersonal Therapy (IPT) treatment. We will also determine non-VA psychotherapy use, using the Cornell Services Index, as patients may have started non-VA psychotherapy after enrollment. Finally, we will construct variables that indicate if the Veteran received any in-person psychotherapy (y/n), completed an adequate trial of any psychotherapy (y/n), received any evidence-based VA psychotherapy (y/n), and completed a trial of evidence-based VA psychotherapy (y/n).

  • Anxiety [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Generalized Anxiety will be measured with the Generalized Anxiety Disorder 7-item (GAD-7). Total score ranges from 0 to 21, with "cut scores" for mild, moderate and severe anxiety. Although originally developed for generalized anxiety disorder symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder and social anxiety disorder.

  • Suicidal Ideation [ Time Frame: change over time (baseline, 3 months, 6 months) ]
    Suicidal Ideation will be measured with the Beck Scale for Suicide Ideation (BSS). The BSS is designed to measure the intensity, pervasiveness, and characteristics of suicide ideation. The BSS has five screening items to decrease the length and the intrusiveness of the questionnaire for non-suicidal patients. If patients have a positive screen, they go on to answer the remaining 14 items, for a total of 21 items. The 21 items are scored on a 3-point Likert scale from 0= not present to 2= maximum severity of suicidal ideation. The score is calculated by summing the ratings for the first 19 items, with scores ranging from 0-38. The scale has good internal consistency with a Cronbach's alpha ranging between 0.87-0.97. The scale also shows evidence of construct and discriminant validity.


Estimated Enrollment: 330
Actual Study Start Date: June 1, 2015
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: March 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PS-cCBT
peer-assisted computerized CBT
Behavioral: Peer-assisted computerized CBT
Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
Active Comparator: EUC
Enhanced usual care
Behavioral: Enhanced usual care
Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.

Detailed Description:

Background:

Antidepressant medications and evidence-based psychotherapies are effective treatments for depression. However, antidepressant medication adherence continues to be suboptimal and offering access to and retaining patients in evidence-based psychotherapies for depression is challenging. The VHA has made major efforts to expand access to and capacity for depression focused evidence-based psychotherapies. However in 2012, only 35% of VA patients with depression completed any psychotherapy visit and only 6% completed 8 psychotherapy visits in 14 weeks, a proxy for an adequate trial.

Initiation and engagement in depression treatment may be increased if patients are offered timely access to a highly flexible, evidence-based treatment options, such as a tailored, web-based computerized cognitive-behavioral therapy (cCBT) program. cCBT has sufficient evidence for effectiveness to be a covered benefit in United Kingdom National Health Service, but has much larger effects when it is supported by clinicians or other trusted individuals. VA peer specialists, an increasing workforce in VHA mental health, are ideal candidates to support patients' engagement in depression treatment and in cCBT. Peers have been shown to promote use of Internet self-management tools, and peer specialist support for cCBT may enhance its completion and overall effectiveness through regular "check ins" and also through providing peer specific experiences, such as sharing of lived experiences and modeling of self management and recovery.

Objectives:

We are conducting a Hybrid Type I RCT of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated CBOCs. Our specific aims are to compare PS-cCBT versus enhanced usual care (EUC) on: a) patient symptomatic, functional, and recovery-oriented outcomes, b) depression coping skills, antidepressant medication adherence, and initiation and completion of more intensive traditional psychotherapy (contingent on symptom level). Our secondary aims are to assess patient, peer, and providers' experiences in PS-cCBT versus EUC using mixed methods. Finally, our exploratory aim is to assess potential mediators of improvements in depressive symptoms or functional status.

Methods:

This is a Hybrid I randomized controlled trial (RCT) of peer-supported cCBT compared to enhanced usual care (EUC) among Veterans with new diagnoses of depression in primary care. The cCBT program consists of 8 modules and will be supported by VA peer specialists with weekly contact for 12 weeks. We will assess patient symptomatic, functional and recovery-oriented outcomes at 12 and 24 week following randomization. We will also assess potential mediators of these outcomes. Bivariate and multivariate study analyses will assess the impact of the two study arms at each assessment point and over time.

Status:

Project is actively recruiting participants

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be eligible for the study if they:

  • have new episodes of depression in primary care, defined as those with a new diagnoses of depression and no prior depression diagnoses or antidepressant fills within 120 days of the index date of their depression diagnosis any of three VA study sites or associated CBOCs. Patients must enroll within 90 days of their diagnosis.
  • have a current Patient Health Questionnaire (PHQ)-9 score > 10.
  • are not receiving mental health care outside of VHA.
  • have broadband internet access at home or confirm willingness, ability, and a plan to go to their VA facility to complete cCBT modules.
  • have familiarity with email and internet use.
  • have stable access to and ability to communicate by telephone.

Exclusion Criteria:

Exclusion criteria for the study will include:

  • a diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) with psychotic features, or Bipolar I in the past 24 months.
  • a positive screen for moderate or severe substance use (AUDIT-C >7).
  • an immediate risk of suicide, requiring hospitalization or urgent evaluation (as evidenced by suicidal plan or intent).
  • participating in other research studies.
  • diagnosis of depression in the past 4 months from a non-VA provider
  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: NCT02057042

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, United States, 49037
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Paul N Pfeiffer, MD MS VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02057042     History of Changes
Other Study ID Numbers: IIR 13-310
Study First Received: January 7, 2014
Last Updated: May 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Peer Support
cCBT
primary care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 27, 2017