Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement

Laura Meis; Shirley M. Glynn; Michele Spoont; Shannon M. Kehle-Forbes; David B Nelson; Carl E Isenhart; Afsoon Eftekhari; Princess E. Ackland; Erin B. Linden; Robert J. Orazem; Andrea H Cutting; Emily M. Hagel Campbell; Millie C. Astin; Katherine E. Porter; Erin Smith; Christopher D. Chuick; Kristen E. Lamp; Tessa C. Vuper; Taylor A. Oakley; Lila B. Khan; Sally K. Keckeisen; Melissa A. Polusny

doi:10.1186/s13063-022-06183-2

Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement

Laura Meis, Shirley M. Glynn, Michele Spoont, Shannon M. Kehle-Forbes, David B Nelson, Carl E Isenhart, Afsoon Eftekhari, Princess E. Ackland, Erin B. Linden, Robert J. Orazem, Andrea H Cutting, Emily M. Hagel Campbell, Millie C. Astin, Katherine E. Porter, Erin Smith, Christopher D. Chuick, Kristen E. Lamp, Tessa C. Vuper, Taylor A. Oakley, Lila B. KhanSally K. Keckeisen, Melissa A. Polusny

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Background: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans’ treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. Methods: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. Discussion: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. Trial registration: ClinicalTrials.govNCT03256227. Registered on August 21, 2017.

Original language	English (US)
Article number	243
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06183-2
State	Published - Dec 2022

Bibliographical note

Funding Information:
This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data.

Funding Information:
The authors would like to thank the study team for their work in support of this project, especially Ann Bangerter, Emily J. Campbell, Gustavo Capo, Emily E. Kloska, Camryn M. Kostick, Jillian Berfield, Gwendolyn C. Hooks, Sally K. Keckeisen, and our talented study therapists. LM is the Chief Investigator, concieved the study, lead the proposal and protocol development, drafted the work, and substantively revised it; SG made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; MS made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; SKF made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; DN made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; CI made substantial contributions to the conception and design of the work and substantively revised work; AE made substantial contributions to the conception and design of the work and substantively revised work; PA made substantial contributions to the acquisiton of data and substantively revised the work; EL made substantial contributions to the acquisiton of data and substantively revised the work; RO made substantial contributions to the acquisiton of data and substantively revised the work; AC made substantial contributions to the design of the work and acquisiton of data; EMC made substantial contributions to the design of the work and acquisiton of data; MA made substantial contributions to the design of the work and acquisiton of data; KP made substantial contributions to the design of the work and acquisiton of data; ES made substantial contributions to the design of the work and acquisiton of data; CC made substantial contributions to the conception of the work, acquisiton of data, and substantively revised the work; KL made substantial contributions to the conception of the work, the acquisiton of data, and substantively revised the work; TV made substantial contributions to the acquisiton of data and substantively revised the work; TO made substantial contributions to the acquisiton of data and drafted the work; LK made substantial contributions to the acquisiton of data and drafted the work; SK made substantial contributions to the acquisiton of data and drafted the work; MP made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it. All authors read and approved the final manuscript. This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data. All IRB-approved study team members may have access to the final trial dataset upon request to the PI and SDMT. There are no contractual agreements that limit investigators’ access to data.

Publisher Copyright:
© 2022, The Author(s).

Keywords

Adherence
Couples
Evidence-based treatments
Family
PTSD
Evidence-Based Practice
Veterans
Humans
Implosive Therapy/methods
Quality of Life
Stress Disorders, Post-Traumatic/diagnosis

PubMed: MeSH publication types

Randomized Controlled Trial
Journal Article

Publisher link

10.1186/s13063-022-06183-2

Find It

Find It at U of M Libraries

Cite this

Meis, L., Glynn, S. M., Spoont, M., Kehle-Forbes, S. M., Nelson, D. B., Isenhart, C. E., Eftekhari, A., Ackland, P. E., Linden, E. B., Orazem, R. J., Cutting, A. H., Hagel Campbell, E. M., Astin, M. C., Porter, K. E., Smith, E., Chuick, C. D., Lamp, K. E., Vuper, T. C., Oakley, T. A., ... Polusny, M. A. (2022). Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement. Trials, 23(1), Article 243. https://doi.org/10.1186/s13063-022-06183-2

Meis, L, Glynn, SM, Spoont, M , Kehle-Forbes, SM , Nelson, DB, Isenhart, CE, Eftekhari, A, Ackland, PE, Linden, EB, Orazem, RJ, Cutting, AH, Hagel Campbell, EM, Astin, MC, Porter, KE, Smith, E, Chuick, CD, Lamp, KE, Vuper, TC, Oakley, TA, Khan, LB, Keckeisen, SK & Polusny, MA 2022, 'Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement', Trials, vol. 23, no. 1, 243. https://doi.org/10.1186/s13063-022-06183-2

@article{a3c89e1a6652494c83c5628d6c9a4db0,

title = "Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement",

abstract = "Background: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans{\textquoteright} treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. Methods: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. Discussion: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. Trial registration: ClinicalTrials.govNCT03256227. Registered on August 21, 2017.",

keywords = "Adherence, Couples, Evidence-based treatments, Family, PTSD, Evidence-Based Practice, Veterans, Humans, Implosive Therapy/methods, Quality of Life, Stress Disorders, Post-Traumatic/diagnosis",

author = "Laura Meis and Glynn, {Shirley M.} and Michele Spoont and Kehle-Forbes, {Shannon M.} and Nelson, {David B} and Isenhart, {Carl E} and Afsoon Eftekhari and Ackland, {Princess E.} and Linden, {Erin B.} and Orazem, {Robert J.} and Cutting, {Andrea H} and {Hagel Campbell}, {Emily M.} and Astin, {Millie C.} and Porter, {Katherine E.} and Erin Smith and Chuick, {Christopher D.} and Lamp, {Kristen E.} and Vuper, {Tessa C.} and Oakley, {Taylor A.} and Khan, {Lila B.} and Keckeisen, {Sally K.} and Polusny, {Melissa A.}",

note = "Funding Information: This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data. Funding Information: The authors would like to thank the study team for their work in support of this project, especially Ann Bangerter, Emily J. Campbell, Gustavo Capo, Emily E. Kloska, Camryn M. Kostick, Jillian Berfield, Gwendolyn C. Hooks, Sally K. Keckeisen, and our talented study therapists. LM is the Chief Investigator, concieved the study, lead the proposal and protocol development, drafted the work, and substantively revised it; SG made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; MS made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; SKF made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; DN made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; CI made substantial contributions to the conception and design of the work and substantively revised work; AE made substantial contributions to the conception and design of the work and substantively revised work; PA made substantial contributions to the acquisiton of data and substantively revised the work; EL made substantial contributions to the acquisiton of data and substantively revised the work; RO made substantial contributions to the acquisiton of data and substantively revised the work; AC made substantial contributions to the design of the work and acquisiton of data; EMC made substantial contributions to the design of the work and acquisiton of data; MA made substantial contributions to the design of the work and acquisiton of data; KP made substantial contributions to the design of the work and acquisiton of data; ES made substantial contributions to the design of the work and acquisiton of data; CC made substantial contributions to the conception of the work, acquisiton of data, and substantively revised the work; KL made substantial contributions to the conception of the work, the acquisiton of data, and substantively revised the work; TV made substantial contributions to the acquisiton of data and substantively revised the work; TO made substantial contributions to the acquisiton of data and drafted the work; LK made substantial contributions to the acquisiton of data and drafted the work; SK made substantial contributions to the acquisiton of data and drafted the work; MP made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it. All authors read and approved the final manuscript. This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data. All IRB-approved study team members may have access to the final trial dataset upon request to the PI and SDMT. There are no contractual agreements that limit investigators{\textquoteright} access to data. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s13063-022-06183-2",

language = "English (US)",

volume = "23",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

TY - JOUR

T1 - Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement

AU - Meis, Laura

AU - Glynn, Shirley M.

AU - Spoont, Michele

AU - Kehle-Forbes, Shannon M.

AU - Nelson, David B

AU - Isenhart, Carl E

AU - Eftekhari, Afsoon

AU - Ackland, Princess E.

AU - Linden, Erin B.

AU - Orazem, Robert J.

AU - Cutting, Andrea H

AU - Hagel Campbell, Emily M.

AU - Astin, Millie C.

AU - Porter, Katherine E.

AU - Smith, Erin

AU - Chuick, Christopher D.

AU - Lamp, Kristen E.

AU - Vuper, Tessa C.

AU - Oakley, Taylor A.

AU - Khan, Lila B.

AU - Keckeisen, Sally K.

AU - Polusny, Melissa A.

N1 - Funding Information: This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data. Funding Information: The authors would like to thank the study team for their work in support of this project, especially Ann Bangerter, Emily J. Campbell, Gustavo Capo, Emily E. Kloska, Camryn M. Kostick, Jillian Berfield, Gwendolyn C. Hooks, Sally K. Keckeisen, and our talented study therapists. LM is the Chief Investigator, concieved the study, lead the proposal and protocol development, drafted the work, and substantively revised it; SG made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; MS made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; SKF made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; DN made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it; CI made substantial contributions to the conception and design of the work and substantively revised work; AE made substantial contributions to the conception and design of the work and substantively revised work; PA made substantial contributions to the acquisiton of data and substantively revised the work; EL made substantial contributions to the acquisiton of data and substantively revised the work; RO made substantial contributions to the acquisiton of data and substantively revised the work; AC made substantial contributions to the design of the work and acquisiton of data; EMC made substantial contributions to the design of the work and acquisiton of data; MA made substantial contributions to the design of the work and acquisiton of data; KP made substantial contributions to the design of the work and acquisiton of data; ES made substantial contributions to the design of the work and acquisiton of data; CC made substantial contributions to the conception of the work, acquisiton of data, and substantively revised the work; KL made substantial contributions to the conception of the work, the acquisiton of data, and substantively revised the work; TV made substantial contributions to the acquisiton of data and substantively revised the work; TO made substantial contributions to the acquisiton of data and drafted the work; LK made substantial contributions to the acquisiton of data and drafted the work; SK made substantial contributions to the acquisiton of data and drafted the work; MP made substantial contributions to the conception and design of the work, drafted the work, and substantively revised it. All authors read and approved the final manuscript. This research was supported by a grant from the Department of Veterans Affairs (HSR&D IIR 15-322). The material is the result of work supported with the use of resources and facilities at the Minneapolis Veterans Affairs Health Care System, VA Ann Arbor Healthcare System, and the Atlanta Veterans Affairs Medical Center. The findings and conclusions in this document are those of the authors and do not represent the views of the Department of Veterans Affairs or the United States government. No investigators have affiliations or financial involvement that conflict with the material presented. The funding body (VA HSR&D) played no role in the design of the study or the collection, analysis, or interpretation of the data. All IRB-approved study team members may have access to the final trial dataset upon request to the PI and SDMT. There are no contractual agreements that limit investigators’ access to data. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - Background: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans’ treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. Methods: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. Discussion: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. Trial registration: ClinicalTrials.govNCT03256227. Registered on August 21, 2017.

AB - Background: Posttraumatic stress disorder occurs in as many as one in five combat veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Trauma-focused treatments, such as Prolonged Exposure, result in clinically significant symptom relief for many. Adherence to these treatments (i.e., session attendance and homework compliance) is vital to ensuring recovery but can be challenging for patients. Engaging families in veterans’ treatment could prove to be an effective strategy for promoting treatment adherence while also addressing long-standing calls for better family inclusion in treatment for posttraumatic stress disorder. This paper describes the methods of a pragmatic randomized controlled trial designed to evaluate if family inclusion in Prolonged Exposure can improve treatment adherence. Methods: One hundred fifty-six veterans, with clinically significant symptoms of posttraumatic stress disorder, will be randomized to receive either standard Prolonged Exposure or Prolonged Exposure enhanced through family inclusion (Family-Supported Prolonged Exposure) across three different VA facilities. Our primary outcomes are session attendance and homework compliance. Secondary outcomes include posttraumatic stress disorder symptom severity, depression, quality of life, and relationship functioning. The study includes a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in Prolonged Exposure within VA. Discussion: While the importance of family involvement in posttraumatic stress disorder treatment is non-controversial, there is no evidence base supporting best practices on how to integrate families into PE or any other individually focused trauma-focused treatments for posttraumatic stress disorder. This study is an important step in addressing this gap, contributing to the literature for both retention and family involvement in trauma-focused treatments. Trial registration: ClinicalTrials.govNCT03256227. Registered on August 21, 2017.

KW - Adherence

KW - Couples

KW - Evidence-based treatments

KW - Family

KW - PTSD

KW - Evidence-Based Practice

KW - Veterans

KW - Humans

KW - Implosive Therapy/methods

KW - Quality of Life

KW - Stress Disorders, Post-Traumatic/diagnosis

UR - http://www.scopus.com/inward/record.url?scp=85127299835&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85127299835&partnerID=8YFLogxK

U2 - 10.1186/s13063-022-06183-2

DO - 10.1186/s13063-022-06183-2

M3 - Article

C2 - 35354481

AN - SCOPUS:85127299835

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 243

ER -

Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

Publisher link

Find It

Other files and links

Fingerprint

Cite this