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Improving Depression Management Through Peer Support (DIAL-UP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00777205
First received: October 21, 2008
Last updated: April 6, 2015
Last verified: November 2014
  Purpose
We conducted a randomized controlled trial (RCT) that compared the effectiveness of a telephone delivered, recovery focused, peer-support intervention to enhanced usual care for VA patients with depression.

Condition Intervention
Depression
Behavioral: Telephone-based peer support
Behavioral: Enhanced Usual Care

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: Improving Depression Management Through Peer Support

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Functional Status-Mental Health (MCS) Over 12 Month Period [ Time Frame: Change over study period ] [ Designated as safety issue: No ]
    The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.

  • Change in Functional Status-Physical Health (PCS) Over 12 Month Period [ Time Frame: Change over study period ] [ Designated as safety issue: No ]
    The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.

  • Quality of Life [ Time Frame: Change over study period ] [ Designated as safety issue: No ]
    The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70).

  • Depression Symptoms [ Time Frame: Change over study period ] [ Designated as safety issue: No ]
    The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  • Recovery Orientation [ Time Frame: Change over study period ] [ Designated as safety issue: No ]
    The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach's α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 - 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.


Enrollment: 443
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enhanced Usual Care
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook, and bi-weekly study mailings with depression management tips.
Behavioral: Enhanced Usual Care
Patients received their usual mental health care plus a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Experimental: Telephone-based peer support
Participants in the intervention arm received usual mental health care and biweekly study mailings. In addition, they had access to a telephone platform over which they could make free calls to their peer partner for mutual peer support over a 6-month period of time.
Behavioral: Telephone-based peer support
Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.
Behavioral: Enhanced Usual Care
Patients received their usual mental health care plus a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.

Detailed Description:

Peer-support interventions have been recommended by prestigious national task forces and incorporated into the VA Comprehensive Mental Health Strategic Plan. Patients who cope with longer term depressive symptoms may benefit from these interventions.This study examines the effectiveness of a feasible, scalable mutual peer-support intervention for VA patients in depression treatment and will inform leaders who are considering implementing peer-support initiatives.

In this study, each study participant (a veteran in treatment for depression) was matched with another participating veteran and the pairs were randomized to enhanced usual care or to the telephone based peer-support intervention (DIAL-UP). All study participants received usual care plus written materials outlining depression self-management strategies, behavioral activation, and recovery.

DIAL-UP participants also received: a) a peer-support manual that outlined peer support principles and provided peer discussion topics and b) access to a specialized telephone platform that permited free calls to their partners, ready access to mental health staff for back-up and advice, and recorded tips on depression management. Patients were encouraged to call their partners at least once per week during the 6-month intervention period. Patient outcomes were assessed at 3, 6, and 12 months following enrollment.

  Eligibility

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

Inclusion Criteria:

  • currently in treatment at Ann Arbor, Detroit, Battle Creek, or Saginaw VA or their associated community based outpatient clinics
  • not receiving formal mental health services or regularly attending mutual self-help programs outside of the VA
  • diagnosis of a depressive disorder in the last 24 months that is confirmed by the relevant clinician
  • being seen less than bi-weekly by clinicians for psychiatric or substance use disorders
  • past trial of psychotherapy and/or antidepressant trial
  • have a current PHQ-9 scores > 10 or WSAS scores > 10
  • have stable access to and ability to communicate by telephone

Exclusion Criteria:

  • diagnosis of schizophrenia, schizoaffective disorder, MDD with psychotic features, or Bipolar I in the past 24 months. Diagnosis of active substance dependence in the past 12 months or substance abuse in the last 6 months
  • an immediate risk of suicide, requiring hospitalization or urgent evaluation
  • clinician assessment that participation in the study could have an adverse impact on the patient or his/her partner.
  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: NCT00777205

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
VA Medical Center, Battle Creek
Battle Creek, Michigan, United States, 49015
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
Aleda E. Lutz VA Medical Center
Saginaw, Michigan, United States, 48602
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Marcia T. Valenstein, MD AB VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00777205     History of Changes
Other Study ID Numbers: IIR 08-325 
Study First Received: October 21, 2008
Results First Received: December 30, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Peer Support
Quality of Life
Telephone

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

ClinicalTrials.gov processed this record on September 30, 2016