Improving Depression Management Through Peer Support

NCT00777205 | Completed Results DMC

• 1 other identifier: IIR 08-325
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

Peer Support; Quality of Life; Telephone

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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.

  Change over study period

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

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

Telephone-based peer support

EXPERIMENTAL

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; Behavioral: Enhanced Usual Care

Interventions

Telephone-based peer support BEHAVIORAL

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.

Telephone-based peer support

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care; Telephone-based peer support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (4)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

VA Medical Center, Battle Creek

Battle Creek, Michigan, 49015, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Aleda E. Lutz VA Medical Center

Saginaw, Michigan, 48602, United States

Location

Related Publications (2)

• 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.

  PMID: 21353125 BACKGROUND

• 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.

  PMID: 24135507 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

56 of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.

Results Point of Contact

• Title: Marcia Valenstein, MD
• Organization: Veterans Affairs Healthcare System

marcia.valenstein@va.gov

734-845-3649

Study Officials

• Marcia T. Valenstein, MD AB

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: February 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 27, 2015
• Results First Posted: March 18, 2015

Record last verified: 2014-11

Locations

US (4)