Posttraumatic Stress DisorderPhase 2/3M2CNCT00640445
Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration
A Phase 2/3 study testing Expressive Writing in people with Posttraumatic Stress Disorder, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,292 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2013
- Phase
- Phase 2/3
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran from current wars in Iraq and Afghanistan
- At least a little difficulty transitioning from soldier to civilian
- Access to computer with internet
- Provide valid contact information
- Available to participate for up to 40 minutes per session
- Interested in participation
- Understand procedures and consent
- Note: participants are recruited by random selection from the target population
Who cannot join
- Severe depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration
Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested. This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW). This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups. Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments. Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention. Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5). The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment. Analyses will primarily entail multivariate analyses of variance. Power is adequate to detect even a small effect.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Expressive Writing, Control Writing
- Keywords
- Clinical Trial, Combat Disorders, PTSD, Internet-Based Intervention, Mental Health Services, Post-deployment Reintegration
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days
Control WritingBehavioural
Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Writing | Experimental | Participants assigned to the Expressive Writing (EW) condition will write about their deepest thoughts and feelings associated with their experience transitioning from being a soldier to being a civilian for 20 minutes a day for 4 days within a week. Receives: Behavioral: Expressive Writing |
| Control Writing | Active comparator | Those assigned to control writing condition will write factually about the information needs of veterans transitioning from active duty to civilian status for 20 minutes on 4 days within one week. Receives: Behavioral: Control Writing |
| No Writing Control | No intervention | Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
Measured: Baseline, 3-month, 6-month
Hostility
Measured: Baseline, 3-month, 6-month
Psychological distress
Measured: Baseline, 3-month, 6-month
Physical symptoms
Measured: Baseline, 3-month, 6-month
Reintegration difficulty
Measured: Baseline, 3-month, 6-month
Social support
Measured: Baseline, 3-month, 6-month
Life satisfaction
Measured: Baseline, 3-month, 6-month
Secondary outcomes (2)
Emotion and causal word use in participants' essays
Measured: Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
Employment status
Measured: Baseline, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Responsible party
- Principal investigator, Nina A. Sayer, Minneapolis Veterans Affairs Medical Center
- Investigators
- Nina A Sayer, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640445
- Sponsor's protocol ID
- PT074432
- Acronym
- M2C
- Status last verified
- Sep 2015
- First submitted
- 18 Mar 2008
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sayer NA, Orazem RJ, Noorbaloochi S, Gravely A, Frazier P, Carlson KF, Schnurr PP, Oleson H. Iraq and Afghanistan War Veterans with Reintegration Problems: Differences by Veterans Affairs Healthcare User Status. Adm Policy Ment Health. 2015 Jul;42(4):493-503. doi: 10.1007/s10488-014-0564-2.
PubMed 24913102
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration
- ClinicalTrials.gov ID
- NCT00640445
- Acronym / sponsor ID
- M2C / PT074432
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Clinical Trial, Combat Disorders, PTSD, Internet-Based Intervention, Mental Health Services, Post-deployment Reintegration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,292 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Mar 2008 (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.
Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested. This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW). This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups. Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments. Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention. Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5). The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment. Analyses will primarily entail multivariate analyses of variance. Power is adequate to detect even a small effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing | Experimental | Behavioral: Expressive WritingParticipants assigned to the Expressive Writing (EW) condition will write about their deepest thoughts and feelings associated with their experience transitioning from being a soldier to being a civilian for 20 minutes a day for 4 days within a week. |
| Control Writing | Active comparator | Behavioral: Control WritingThose assigned to control writing condition will write factually about the information needs of veterans transitioning from active duty to civilian status for 20 minutes on 4 days within one week. |
| No Writing Control | No intervention | –Treatment As Usual |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Veteran from current wars in Iraq and Afghanistan
- At least a little difficulty transitioning from soldier to civilian
- Access to computer with internet
- Provide valid contact information
- Available to participate for up to 40 minutes per session
Key exclusion criteria (1 listed)
- Severe depression
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 |
|---|---|---|
| Expressive WritingIn EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days | Behavioural | Expressive Writing |
| Control WritingThose assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days. | Behavioural | Control Writing |
Primary outcome
PTSD symptoms
Time frame: Baseline, 3-month, 6-month
Hostility
Time frame: Baseline, 3-month, 6-month
Psychological distress
Time frame: Baseline, 3-month, 6-month
Physical symptoms
Time frame: Baseline, 3-month, 6-month
Reintegration difficulty
Time frame: Baseline, 3-month, 6-month
Social support
Time frame: Baseline, 3-month, 6-month
Life satisfaction
Time frame: Baseline, 3-month, 6-month
2 secondary outcomes
Emotion and causal word use in participants' essays
Time frame: Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
Employment status
Time frame: Baseline, 3-month, 6-month
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 23 Sep 2015.
- Results publication: PubMed 24913102Sayer NA, Orazem RJ, Noorbaloochi S, Gravely A, Frazier P, Carlson KF, Schnurr PP, Oleson H. Iraq and Afghanistan War Veterans with Reintegration Problems: Differences by Veterans Affairs Healthcare User Status. Adm Policy Ment Health. 2015 Jul;42(4):493-503. doi: 10.1007/s10488-014-0564-2.
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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.
Nina A Sayer, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Expressive Writing in people with Posttraumatic Stress Disorder, run by Minneapolis 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 8 inclusion and 1 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 23 Sep 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PTSD symptoms (time frame: Baseline, 3-month, 6-month). The study lists 7 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 NCT00640445, which also lists 1 linked publication.
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 23 Sep 2015.