- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777205
Improving Depression Management Through Peer Support (DIAL-UP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Battle Creek, Michigan, United States, 49015
- VA Medical Center, Battle Creek
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Detroit, Michigan, United States, 48201
- John D. Dingell VA Medical Center, Detroit, MI
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Saginaw, Michigan, United States, 48602
- Aleda E. Lutz VA Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
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|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
Time Frame: Change over study 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 over study period
|
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Change in Functional Status-Physical Health (PCS) Over 12 Month Period
Time Frame: Change over study 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 over study period
|
|
Quality of Life
Time Frame: Change over study period
|
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).
|
Change over study period
|
|
Depression Symptoms
Time Frame: Change over study period
|
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.
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Change over study period
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Recovery Orientation
Time Frame: Change over study period
|
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.
|
Change over study period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marcia T. Valenstein, MD AB, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 08-325
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