Posttraumatic Stress DisorderNCT00893152
Family Involvement in Treatment for PTSD
An observational study of Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a powerful impact on family functioning. Good family relationships appear to moderate its impact; stressful relationships may reduce the benefits of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Mar 2012
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veteran participants were OIF/OEF veterans receiving outpatient treatment for PTSD at the Little Rock or Oklahoma City VAMCs. Each veteran participant was asked to designate an adult family member/friend to participate in a separate interview.
Who may be able to join
- Veteran:
- Age 18-65;
- 2 or more inpatient or outpatient mental health contacts at LR or OKC VAMC in the previous 12 months with a primary diagnosis of PTSD;
- Served in Iraq or Afghanistan since 10/7/01;
- Have a family member who may be willing to participate in the focus group.
- Family:
Show all 9Show fewer
- Age > 18
- English speaking
- Be the designated "family member" of a participating veteran
Who cannot join
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
About this study
Official title: Perspectives on Enhancing Family Involvement in Treatment for PTSD
Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a powerful impact on family functioning. Good family relationships appear to moderate its impact; stressful relationships may reduce the benefits of treatment. A program that assists both Veteran and family in coping with the Veteran's PTSD could directly improve the Veteran's re-adjustment and well-being and indirectly improve his/her social and occupational functioning.
Read the detailed description
Background: Post-traumatic stress disorder (PTSD), a potentially severe and persistent condition that affects social, occupational and family functioning, is prevalent among returning OIF/OEF veterans. PTSD has a powerful impact on family functioning. Because good family relationships appear to moderate its impact, while stressful relationships may reduce the benefits of treatment, a program that enhances family functioning by assisting both veteran and family in coping with the veteran's PTSD could directly improve the veteran's adjustment and well-being, and indirectly improve his/her social and occupational functioning. Effective programs for OIF/OEF veterans are urgently needed. This study will address critical gaps in knowledge about relevant needs and preferences of OIF/OEF veterans and families, and how best to involve families in treatment.
Objectives: The specific aim of this project is to describe the needs and preferences of OIF/OEF service-era veterans with PTSD and their families relevant to family involvement in care.
Methods: This two-site study was conducted at the Central Arkansas Veterans Healthcare System (CAVHS, Little Rock, AR) and Oklahoma City (OKC) VAMCs. Qualitative (focus-group or individual) interviews were conducted with 47 Veterans (33 CAVHS, 14 OKC) and 36 Veteran-designated family members (19 CAVHS/17 OKC). Veterans were eligible if they were 18-65 years of age, had served in Iraq or Afghanistan since October 2001, had received treatment for PTSD at the CAVHS or OKC VAMCs in the previous 12 months, and had an adult family member who might be willing to participate in an interview. Family was defined broadly to include relatives, significant others, and friends the Veteran considered "as close as family." Interviews addressed perceived needs related to the Veteran's readjustment to civilian life, desires for family involvement in treatment, types of services that were/would have been helpful and attractive during readjustment, as well as logistic considerations (e.g., frequency of meetings). Qualitative data were analyzed using the techniques of constant comparison and content analysis. Demographic data, deployment data, and data on preferred program structure and format were collected via an anonymous paper-and-pencil questionnaire administered following the qualitative interview.
Status: Data collection and analysis of main themes are complete. In depth analysis of additional themes is ongoing.
- Conditions
- Posttraumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Male veterans (focus groups and individual interviews) | |
| Group 2 | Female veterans (focus groups and individual interviews) | |
| Group 3 | Family members of participating veterans (focus groups and individual interviews) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment
This is qualitative research. "Outcomes" were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members.
Measured: During the 1-1.5 hour interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionMar 2012
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.
- 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
- Observational
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ellen P. Fischer, PhD, Principal investigator, Central Arkansas Veterans Healthcare System (North Little Rock)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893152
- Sponsor's protocol ID
- DHI 08-097
- Other IDs
- CAVHS 0156_2008I
- Status last verified
- Mar 2015
- First submitted
- 1 May 2009
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives on Enhancing Family Involvement in Treatment for PTSD
- ClinicalTrials.gov ID
- NCT00893152
- Acronym / sponsor ID
- DHI 08-097
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a powerful impact on family functioning. Good family relationships appear to moderate its impact; stressful relationships may reduce the benefits of treatment. A program that assists both Veteran and family in coping with the Veteran's PTSD could directly improve the Veteran's re-adjustment and well-being and indirectly improve his/her social and occupational functioning.
Detailed description
Background: Post-traumatic stress disorder (PTSD), a potentially severe and persistent condition that affects social, occupational and family functioning, is prevalent among returning OIF/OEF veterans. PTSD has a powerful impact on family functioning. Because good family relationships appear to moderate its impact, while stressful relationships may reduce the benefits of treatment, a program that enhances family functioning by assisting both veteran and family in coping with the veteran's PTSD could directly improve the veteran's adjustment and well-being, and indirectly improve his/her social and occupational functioning. Effective programs for OIF/OEF veterans are urgently needed. This study will address critical gaps in knowledge about relevant needs and preferences of OIF/OEF veterans and families, and how best to involve families in treatment.
Objectives: The specific aim of this project is to describe the needs and preferences of OIF/OEF service-era veterans with PTSD and their families relevant to family involvement in care.
Methods: This two-site study was conducted at the Central Arkansas Veterans Healthcare System (CAVHS, Little Rock, AR) and Oklahoma City (OKC) VAMCs. Qualitative (focus-group or individual) interviews were conducted with 47 Veterans (33 CAVHS, 14 OKC) and 36 Veteran-designated family members (19 CAVHS/17 OKC). Veterans were eligible if they were 18-65 years of age, had served in Iraq or Afghanistan since October 2001, had received treatment for PTSD at the CAVHS or OKC VAMCs in the previous 12 months, and had an adult family member who might be willing to participate in an interview. Family was defined broadly to include relatives, significant others, and friends the Veteran considered "as close as family." Interviews addressed perceived needs related to the Veteran's readjustment to civilian life, desires for family involvement in treatment, types of services that were/would have been helpful and attractive during readjustment, as well as logistic considerations (e.g., frequency of meetings). Qualitative data were analyzed using the techniques of constant comparison and content analysis. Demographic data, deployment data, and data on preferred program structure and format were collected via an anonymous paper-and-pencil questionnaire administered following the qualitative interview.
Status: Data collection and analysis of main themes are complete. In depth analysis of additional themes is ongoing.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Male veterans (focus groups and individual interviews) |
| Group 2 | – | –Female veterans (focus groups and individual interviews) |
| Group 3 | – | –Family members of participating veterans (focus groups and individual interviews) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veteran participants were OIF/OEF veterans receiving outpatient treatment for PTSD at the Little Rock or Oklahoma City VAMCs. Each veteran participant was asked to designate an adult family member/friend to participate in a separate interview.
Key inclusion criteria (9 listed)
- Age 18-65;
- 2 or more inpatient or outpatient mental health contacts at LR or OKC VAMC in the previous 12 months with a primary diagnosis of PTSD;
- Served in Iraq or Afghanistan since 10/7/01;
- Have a family member who may be willing to participate in the focus group.
- Age > 18
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment
Time frame: During the 1-1.5 hour interviews
This is qualitative research. "Outcomes" were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellen P. Fischer, PhD principal investigator
Central Arkansas Veterans Healthcare System (North Little Rock)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 2 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 9 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 14 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 2 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 23 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?
Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment (time frame: During the 1-1.5 hour interviews). 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 14 Apr 2015.