DepressionDIAL-UPNCT00777205

Improving Depression Management Through Peer Support

A study testing Telephone-based peer support in people with Depression, run by US Department of Veterans Affairs at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Telephone-based peer support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 443 participants
Where: 4 sitesUnited States
Study dates: Feb 2010to Sep 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
VA Medical Center, Battle Creek
Battle Creek, Michigan, 49015
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
Aleda E. Lutz VA Medical Center
Saginaw, Michigan, 48602

Other trials in United States

About this study

Read the 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.

Conditions: Depression
Being tested: Telephone-based peer support, Enhanced Usual Care
Keywords: Peer Support, Quality of Life, Telephone
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telephone-based peer supportBehavioural
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 CareBehavioural
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.

Study groups in NCT00777205
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Telephone-based peer support; Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change over study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Sep 2013

First posted22 Oct 2008 (estimated)
Study startFeb 2010
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777205
Sponsor's protocol ID: IIR 08-325
Acronym: DIAL-UP
Status last verified: Nov 2014
First submitted: 21 Oct 2008
Last updated: 27 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 21353125
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.
PubMed 24135507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Depression Management Through Peer Support
ClinicalTrials.gov ID: NCT00777205
Acronym / sponsor ID: DIAL-UP / IIR 08-325
Conditions: Depression
Keywords: Peer Support, Quality of Life, Telephone
Study type: Interventional
Recruitment status: Completed
Enrolment: 443 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Feb 2010
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 18 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Enhanced Usual Care	Active comparator	Behavioral: Enhanced Usual CarePatients 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.
Telephone-based peer support	Experimental	Behavioral: Telephone-based peer support, Behavioral: Enhanced Usual CareParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telephone-based peer supportPatients 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.	Behavioural	Telephone-based peer support
Enhanced Usual CarePatients 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.	Behavioural	Enhanced Usual Care, Telephone-based peer support

Primary outcome

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 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.
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).
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.
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.

Results and safety

Results posted to the registry on 18 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Usual Care	243	212
Telephone-based Peer Support	200	129

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

Time frame: Change over study period. Mean (Standard Deviation). Unit: units on a scale

Measure	Enhanced Usual Care n = 240	Telephone-based Peer Support n = 137
Baseline	32.71 (9.91)	33.72 (10.97)
3-month	34.77 (11.59)	36.58 (11.23)
6-month	36.6 (11.48)	37.52 (11.65)
12-month	36.99 (11.00)	37.24 (11.14)

Enhanced Usual Care vs Telephone-based Peer Support: Slope: 0.22 (95% CI -1.57 to 2.01), p <0.05, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Change in Functional Status-Physical Health (PCS) Over 12 Month Period

Time frame: Change over study period. Mean (Standard Deviation). Unit: units on a scale

Measure	Enhanced Usual Care n = 240	Telephone-based Peer Support n = 137
Baseline	36.63 (10.64)	34.62 (10.44)
3-month	37.68 (11.10)	35.14 (11.18)
6-month	36.91 (10.89)	34.64 (11.31)
12-month	36.72 (11.16)	35.48 (11.13)

Enhanced Usual Care vs Telephone-based Peer Support: Slope: -0.39 (95% CI -2.03 to 1.24), p <0.05, Mixed Models Analysis

Primary outcome: Quality of Life

Time frame: Change over study period. Mean (Standard Deviation). Unit: units on a scale

Measure	Enhanced Usual Care n = 242	Telephone-based Peer Support n = 139
Baseline	38.80 (8.74)	38.82 (9.22)
3-Month	41.14 (9.07)	41.75 (9.42)
6-Month	41.89 (9.76)	42.55 (9.66)
12-month	42.69 (9.97)	42.55 (9.55)

Enhanced Usual Care vs Telephone-based Peer Support: Slope: 0.81 (95% CI -0.93 to 2.55), p <0.05, Mixed Models Analysis

Primary outcome: Depression Symptoms

Time frame: Change over study period. Mean (Standard Deviation). Unit: units on a scale

Measure	Enhanced Usual Care n = 243	Telephone-based Peer Support n = 144
Baseline	25.60 (10.29)	25.16 (11.34)
3-Month	20.77 (11.72)	19.51 (11.23)
6-month	18.86 (11.63)	18.17 (12.29)
12-month	17.82 (11.73)	17.15 (10.86)

Enhanced Usual Care vs Telephone-based Peer Support: Slope: -.039 (95% CI -2.66 to 1.89), p <0.05, Mixed Models Analysis

Adverse events

Time frame: Time frame was March 2010-October 2013 for a total of 3 years and 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Usual Care	5 of 243 (2.1%)	0 of 243 (0%)	Not reported
Telephone-based Peer Support	2 of 144 (1.4%)	0 of 144 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21353125Pfeiffer 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.
Results publication: PubMed 24135507Pfeiffer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcia T. Valenstein, MD AB principal investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telephone-based peer support in people with Depression, run by US Department of Veterans Affairs at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Status-Mental Health (MCS) Over 12 Month Period (time frame: Change over study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00777205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015; AzTrials last refreshed its copy on 28 Oct 2026.