Trial Outcomes & Findings for Improving Depression Management Through Peer Support (NCT NCT00777205)
NCT ID: NCT00777205
Last Updated: 2015-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
443 participants
Primary outcome timeframe
Change over study period
Results posted on
2015-04-27
Participant Flow
Participants were recruited from a total of 15 VA mental health clinics, located within four VA Healthcare Systems and their affiliated Community Based Outpatient Centers.
Participant milestones
| Measure |
Enhanced Usual Care
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
200
|
|
Overall Study
Intervention Interruption
|
0
|
56
|
|
Overall Study
COMPLETED
|
212
|
129
|
|
Overall Study
NOT COMPLETED
|
31
|
71
|
Reasons for withdrawal
| Measure |
Enhanced Usual Care
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
56
|
Baseline Characteristics
Improving Depression Management Through Peer Support
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=243 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=144 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 years
|
48 participants
n=5 Participants
|
25 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
161 participants
n=5 Participants
|
91 participants
n=7 Participants
|
252 participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
34 participants
n=5 Participants
|
28 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change over study periodPopulation: Fifty-six 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.
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=240 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=137 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
Baseline
|
32.71 units on a scale
Standard Deviation 9.91
|
33.72 units on a scale
Standard Deviation 10.97
|
|
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
3-month
|
34.77 units on a scale
Standard Deviation 11.59
|
36.58 units on a scale
Standard Deviation 11.23
|
|
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
6-month
|
36.6 units on a scale
Standard Deviation 11.48
|
37.52 units on a scale
Standard Deviation 11.65
|
|
Change in Functional Status-Mental Health (MCS) Over 12 Month Period
12-month
|
36.99 units on a scale
Standard Deviation 11.00
|
37.24 units on a scale
Standard Deviation 11.14
|
PRIMARY outcome
Timeframe: Change over study periodPopulation: Fifty-six 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.
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=240 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=137 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Change in Functional Status-Physical Health (PCS) Over 12 Month Period
Baseline
|
36.63 units on a scale
Standard Deviation 10.64
|
34.62 units on a scale
Standard Deviation 10.44
|
|
Change in Functional Status-Physical Health (PCS) Over 12 Month Period
3-month
|
37.68 units on a scale
Standard Deviation 11.10
|
35.14 units on a scale
Standard Deviation 11.18
|
|
Change in Functional Status-Physical Health (PCS) Over 12 Month Period
6-month
|
36.91 units on a scale
Standard Deviation 10.89
|
34.64 units on a scale
Standard Deviation 11.31
|
|
Change in Functional Status-Physical Health (PCS) Over 12 Month Period
12-month
|
36.72 units on a scale
Standard Deviation 11.16
|
35.48 units on a scale
Standard Deviation 11.13
|
PRIMARY outcome
Timeframe: Change over study periodPopulation: Fifty-six 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.
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).
Outcome measures
| Measure |
Enhanced Usual Care
n=242 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=139 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Quality of Life
Baseline
|
38.80 units on a scale
Standard Deviation 8.74
|
38.82 units on a scale
Standard Deviation 9.22
|
|
Quality of Life
3-Month
|
41.14 units on a scale
Standard Deviation 9.07
|
41.75 units on a scale
Standard Deviation 9.42
|
|
Quality of Life
6-Month
|
41.89 units on a scale
Standard Deviation 9.76
|
42.55 units on a scale
Standard Deviation 9.66
|
|
Quality of Life
12-month
|
42.69 units on a scale
Standard Deviation 9.97
|
42.55 units on a scale
Standard Deviation 9.55
|
PRIMARY outcome
Timeframe: Change over study periodPopulation: Fifty-six 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.
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=243 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=144 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Depression Symptoms
Baseline
|
25.60 units on a scale
Standard Deviation 10.29
|
25.16 units on a scale
Standard Deviation 11.34
|
|
Depression Symptoms
3-Month
|
20.77 units on a scale
Standard Deviation 11.72
|
19.51 units on a scale
Standard Deviation 11.23
|
|
Depression Symptoms
6-month
|
18.86 units on a scale
Standard Deviation 11.63
|
18.17 units on a scale
Standard Deviation 12.29
|
|
Depression Symptoms
12-month
|
17.82 units on a scale
Standard Deviation 11.73
|
17.15 units on a scale
Standard Deviation 10.86
|
PRIMARY outcome
Timeframe: Change over study periodPopulation: Fifty-six 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.
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=239 Participants
Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=138 Participants
Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Recovery Orientation
Baseline
|
64.23 units on a scale
Standard Deviation 18.89
|
64.10 units on a scale
Standard Deviation 18.73
|
|
Recovery Orientation
3-Month
|
67.37 units on a scale
Standard Deviation 19.98
|
68.47 units on a scale
Standard Deviation 19.47
|
|
Recovery Orientation
6-month
|
71.25 units on a scale
Standard Deviation 19.51
|
70.50 units on a scale
Standard Deviation 20.08
|
|
Recovery Orientation
12-month
|
73.06 units on a scale
Standard Deviation 19.82
|
69.81 units on a scale
Standard Deviation 18.66
|
Adverse Events
Enhanced Usual Care
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone-based Peer Support
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Usual Care
n=243 participants at risk
Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
Telephone-based Peer Support
n=144 participants at risk
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 a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/243 • Time frame was March 2010-October 2013 for a total of 3 years and 7 months.
|
1.4%
2/144 • Time frame was March 2010-October 2013 for a total of 3 years and 7 months.
|
|
Psychiatric disorders
Inpatient Psychiatric Hospitalization
|
2.1%
5/243 • Time frame was March 2010-October 2013 for a total of 3 years and 7 months.
|
0.00%
0/144 • Time frame was March 2010-October 2013 for a total of 3 years and 7 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Marcia Valenstein, MD
Veterans Affairs Healthcare System
Phone: 734-845-3649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place