Improving Depression Management Through Peer Support

Depression Clinical Trial

— DIAL-UP  

Official title:

Improving Depression Management Through Peer Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777205
• Other study ID #: IIR 08-325
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: April 6, 2015
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Medical Center, Battle Creek	Battle Creek	Michigan
United States	John D. Dingell VA Medical Center, Detroit, MI	Detroit	Michigan
United States	Aleda E. Lutz VA Medical Center	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Ep — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 over study period	No
Primary	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.	Change over study period	No
Primary	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).	Change over study period	No
Primary	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.	Change over study period	No
Primary	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 a =.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	No