跳至主要内容
临床试验/NCT00777205
NCT00777205已完成不适用

Improving Depression Management Through Peer Support

US Department of Veterans Affairs4 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
443
试验地点
4
主要终点
Depression Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Enhanced Usual Care (Behavioral)

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.

干预措施: Telephone-based peer support (Behavioral)

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.

干预措施: Enhanced Usual Care (Behavioral)

结局指标

主要结局

Depression Symptoms

时间窗: 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.

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

时间窗: 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 in Functional Status-Physical Health (PCS) Over 12 Month Period

时间窗: 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.

Quality of Life

时间窗: 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).

Recovery Orientation

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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