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Improving Depression Management Through Peer Support (DIAL-UP)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based peer support
Enhanced Usual Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Peer Support, Quality of Life, Telephone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • VA Medical Center, Battle Creek
  • John D. Dingell VA Medical Center, Detroit, MI
  • Aleda E. Lutz VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Usual Care

Telephone-based peer support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Functional Status-Mental Health (MCS) Over 12 Month Period
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
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00777205
Brief Title
Improving Depression Management Through Peer Support
Acronym
DIAL-UP
Official Title
Improving Depression Management Through Peer Support
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Peer Support, Quality of Life, Telephone

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telephone-based peer support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based peer support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
Description
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.
Time Frame
Change over study period
Title
Change in Functional Status-Physical Health (PCS) Over 12 Month Period
Description
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.
Time Frame
Change over study period
Title
Quality of Life
Description
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).
Time Frame
Change over study period
Title
Depression Symptoms
Description
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.
Time Frame
Change over study period
Title
Recovery Orientation
Description
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.
Time Frame
Change over study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia T. Valenstein, MD AB
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
VA Medical Center, Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
John D. Dingell VA Medical Center, Detroit, MI
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Aleda E. Lutz VA Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21353125
Citation
Pfeiffer PN, Heisler M, Piette JD, Rogers MA, Valenstein M. Efficacy of peer support interventions for depression: a meta-analysis. Gen Hosp Psychiatry. 2011 Jan-Feb;33(1):29-36. doi: 10.1016/j.genhosppsych.2010.10.002. Epub 2010 Nov 13.
Results Reference
background
PubMed Identifier
24135507
Citation
Pfeiffer PN, Brandfon S, Garcia E, Duffy S, Ganoczy D, Myra Kim H, Valenstein M. Predictors of suicidal ideation among depressed Veterans and the interpersonal theory of suicide. J Affect Disord. 2014 Jan;152-154:277-81. doi: 10.1016/j.jad.2013.09.025. Epub 2013 Oct 4.
Results Reference
result

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Improving Depression Management Through Peer Support

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