Combat DisordersNCT00419029
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
A study testing telephone-administered motivational interviewing in people with Combat Disorders and Stress Disorders, Post-Traumatic, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who screen positive for mental health disorders on telephone… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Combat Disorders, Stress Disorders, Post-Traumatic, Depression
- What is being tested?
- telephone-administered motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran of OEF/OIF with service in Iraq or Afghanistan, or areas surrounding these combat theaters
- Military service separation date after 9/30/01
- Has a zip code that corresponds to a Northern California address and no plans to relocate
- May be contacted by telephone
- Must screen positive for one or more of the following: PTSD, depression, high-risk alcohol and/or illicit substance use to enroll in the randomized controlled trial.
Who cannot join
- Veterans who served post-9/11/01 but who did not serve in Operation Enduring Freedom or Operation Iraqi Freedom
- In VA or non-VA mental health treatment currently
- Residing more than 60 miles from San Francisco VA or a Community-based outpatient clinic associated with San Francisco VA
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment
The goal of this randomized controlled trial is to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who screen positive for mental health disorders on telephone assessment. The investigators will evaluate whether TAMI results in improved mental health treatment engagement, decreased mental health symptoms and increased quality of life among OEF/OIF veterans with mental health disorders. The long-term aim of this study is to conduct rapid assessment and intervention to prevent chronic mental illness and associated disability among our newest generation of veterans.
Read the detailed description
Project Background/Rationale: Recent reports suggest that a substantial proportion of OEF/OIF veterans suffer from one or more co-occurring mental health disorders, particularly post-traumatic stress disorder (PTSD), depression, and substance use disorders. Many newly returning veterans fail to initiate or complete an adequate course of mental health treatment largely owing to barriers that include inherent features of the mental illness, practical and logistical concerns, and stigma. Untreated mental illness threatens to produce functional and occupational disability as occurred with Vietnam-era veterans. Motivational Interviewing (MI) is an evidence-based, client-centered, therapeutic technique shown to enhance mental health treatment engagement in high-risk populations by helping patients explore and resolve barriers to care.
Project Objectives: The aims of this proposal are: (1) to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) compared to telephone-administered informational support sessions (Control) to enhance mental health treatment initiation and retention among OEF/OIF veterans who screen positive for one or more mental health disorders; (2) to compare change in mental health symptoms and quality of life among veterans assigned to TAMI versus Control, and (3) to describe barriers to mental health treatment engagement among OEF/OIF veterans and assess the putative mechanism by which TAMI increases mental health treatment engagement.
Project Methods: The study is a two-arm randomized controlled trial. We will conduct telephone-administered psychometric screening for PTSD, depression, high-risk alcohol and substance use among 1,000 OEF/OIF veterans residing in Northern California. In addition, we will collect baseline data on sociodemographic and military service-related characteristics, VA and non-VA mental health treatment experiences, barriers and motivation to initiate and/or follow-up with VA mental health appointments. Approximately 300 OEF/OIF veterans screening positive for one or more mental health disorders will receive a referral to mental health treatment in their area and will be randomly assigned to either an initial TAMI session followed by two booster TAMI sessions at 1 and 3 months versus three informational support sessions balanced for time and attention. We will measure outcomes at baseline, one, three, and six months. We will test the hypotheses that OEF/OIF veterans receiving TAMI as compared to the Control condition will be more motivated and hence more likely to overcome barriers to initiate and attend follow-up VA mental health treatment appointments and will have greater improvements in mental health symptoms and quality of life.
- Conditions
- Combat Disorders, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
- Being tested
- telephone-administered motivational interviewing, control
- Keywords
- combat, depression, PTSD, substance abuse
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-administered motivational interviewingBehavioural
telephone motivational interviewing
controlBehavioural
brief telephone check-in (no motivational interviewing)
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | brief telephone check-in (no motivational interviewing) Receives: Behavioral: control |
| telephone-administered motivational interviewing | Experimental | motivational interviewing sessions Receives: Behavioral: telephone-administered motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of TAMI, the primary outcome is the binary distinction between those who make an initial phone call to the OEF/OIF Combat Case Manager to arrange for a mental health treatment appointment versus those who do not (Aim 1).
Measured: measured 6 months post last follow-up appointment
Secondary outcomes (5)
the binary distinction between attending an initial or re-engagement VA mental health treatment appointment versus not
Measured: 6 months post last follow-up appointment
the total number of VA mental health treatment sessions attended
Measured: 6 months p ost last follow-up appointment
the proportion of sessions attended per those scheduled during the 6-month follow-up period
Measured: 6 months post last follow-up
change in mental health symptom scores between the TAMI and Control groups
Measured: last follow-up appointment
change in quality of life score from baseline at 1, 3, and 6 months.
Measured: last follow-up appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combat DisordersStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Karen Seal, San Francisco Veterans Affairs Medical Center
- Investigators
- Karen H Seal, MD, MPH, Principal investigator, San Francisco VA Medical Center, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419029
- Sponsor's protocol ID
- MH 06-004
- Status last verified
- Aug 2014
- First submitted
- 4 Jan 2007
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Engage OEF/OIF Veterans in Mental Health Treatment
- ClinicalTrials.gov ID
- NCT00419029
- Acronym / sponsor ID
- MH 06-004
- Conditions
- Combat Disorders, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
- Keywords
- combat, depression, PTSD, substance abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) to enhance VA mental health treatment engagement among veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) who screen positive for mental health disorders on telephone assessment. The investigators will evaluate whether TAMI results in improved mental health treatment engagement, decreased mental health symptoms and increased quality of life among OEF/OIF veterans with mental health disorders. The long-term aim of this study is to conduct rapid assessment and intervention to prevent chronic mental illness and associated disability among our newest generation of veterans.
Detailed description
Project Background/Rationale: Recent reports suggest that a substantial proportion of OEF/OIF veterans suffer from one or more co-occurring mental health disorders, particularly post-traumatic stress disorder (PTSD), depression, and substance use disorders. Many newly returning veterans fail to initiate or complete an adequate course of mental health treatment largely owing to barriers that include inherent features of the mental illness, practical and logistical concerns, and stigma. Untreated mental illness threatens to produce functional and occupational disability as occurred with Vietnam-era veterans. Motivational Interviewing (MI) is an evidence-based, client-centered, therapeutic technique shown to enhance mental health treatment engagement in high-risk populations by helping patients explore and resolve barriers to care.
Project Objectives: The aims of this proposal are: (1) to evaluate the efficacy of telephone-administered motivational interviewing (TAMI) compared to telephone-administered informational support sessions (Control) to enhance mental health treatment initiation and retention among OEF/OIF veterans who screen positive for one or more mental health disorders; (2) to compare change in mental health symptoms and quality of life among veterans assigned to TAMI versus Control, and (3) to describe barriers to mental health treatment engagement among OEF/OIF veterans and assess the putative mechanism by which TAMI increases mental health treatment engagement.
Project Methods: The study is a two-arm randomized controlled trial. We will conduct telephone-administered psychometric screening for PTSD, depression, high-risk alcohol and substance use among 1,000 OEF/OIF veterans residing in Northern California. In addition, we will collect baseline data on sociodemographic and military service-related characteristics, VA and non-VA mental health treatment experiences, barriers and motivation to initiate and/or follow-up with VA mental health appointments. Approximately 300 OEF/OIF veterans screening positive for one or more mental health disorders will receive a referral to mental health treatment in their area and will be randomly assigned to either an initial TAMI session followed by two booster TAMI sessions at 1 and 3 months versus three informational support sessions balanced for time and attention. We will measure outcomes at baseline, one, three, and six months. We will test the hypotheses that OEF/OIF veterans receiving TAMI as compared to the Control condition will be more motivated and hence more likely to overcome barriers to initiate and attend follow-up VA mental health treatment appointments and will have greater improvements in mental health symptoms and quality of life.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: controlbrief telephone check-in (no motivational interviewing) |
| telephone-administered motivational interviewing | Experimental | Behavioral: telephone-administered motivational interviewingmotivational interviewing sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran of OEF/OIF with service in Iraq or Afghanistan, or areas surrounding these combat theaters
- Military service separation date after 9/30/01
- Has a zip code that corresponds to a Northern California address and no plans to relocate
- May be contacted by telephone
- Must screen positive for one or more of the following: PTSD, depression, high-risk alcohol and/or illicit substance use to enroll in the randomized controlled trial.
Key exclusion criteria (3 listed)
- Veterans who served post-9/11/01 but who did not serve in Operation Enduring Freedom or Operation Iraqi Freedom
- In VA or non-VA mental health treatment currently
- Residing more than 60 miles from San Francisco VA or a Community-based outpatient clinic associated with San Francisco VA
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-administered motivational interviewingtelephone motivational interviewing | Behavioural | telephone-administered motivational interviewing |
| controlbrief telephone check-in (no motivational interviewing) | Behavioural | control |
Primary outcome
To determine the efficacy of TAMI, the primary outcome is the binary distinction between those who make an initial phone call to the OEF/OIF Combat Case Manager to arrange for a mental health treatment appointment versus those who do not (Aim 1).
Time frame: measured 6 months post last follow-up appointment
5 secondary outcomes
the binary distinction between attending an initial or re-engagement VA mental health treatment appointment versus not
Time frame: 6 months post last follow-up appointment
the total number of VA mental health treatment sessions attended
Time frame: 6 months p ost last follow-up appointment
the proportion of sessions attended per those scheduled during the 6-month follow-up period
Time frame: 6 months post last follow-up
change in mental health symptom scores between the TAMI and Control groups
Time frame: last follow-up appointment
change in quality of life score from baseline at 1, 3, and 6 months.
Time frame: last follow-up appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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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.
Karen H Seal, MD, MPH principal investigator
San Francisco VA Medical Center, University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-administered motivational interviewing in people with Combat Disorders and Stress Disorders, Post-Traumatic, run by San Francisco Veterans Affairs Medical Center at 1 site 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 5 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 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the efficacy of TAMI, the primary outcome is the binary distinction between those who make an initial phone call to the OEF/OIF Combat Case Manager to arrange for a mental health treatment appointment versus those who do not (Aim 1). (time frame: measured 6 months post last follow-up appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2014.