Top

Published in:

Open Access 01-12-2022 | Study protocol

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

Authors: Laura A. Meis, Shirley M. Glynn, Michele R. Spoont, Shannon M. Kehle-Forbes, David Nelson, Carl E. Isenhart, Afsoon Eftekhari, Princess E. Ackland, Erin B. Linden, Robert J. Orazem, Andrea 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

Published in: Trials | Issue 1/2022

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.

Institute of Medicine. Treatment for posttraumatic stress disorder in military and veteran populations: Final assessment. Washington, DC: The National Academies Press; 2014.

The Management of Posttraumatic Stress Disorder Work Group. VA/DOD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. In: Management of Posttraumatic Stress Disorder and Acute Stress. VA/DoD Clinical Practice Guidelines; 2017. https://www.healthquality.va.gov/guidelines/MH/ptsd/VADoDPTSDCPGFinal012418.pdf. Accessed 12 Jan 2022.

Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for military-related PTSD: A review of randomized clinical trials. JAMA. 2015;314(5):489–500.CrossRef

Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. American journal of Psychiatry. 2005;162(2):214–27. https://doi.org/10.1176/appi.ajp.162.2.214.CrossRef

Kline AC, Cooper AA, Rytwinksi NK, Feeny NC. Long-term efficacy of psychotherapy for posttraumatic stress disorder: a meta-analysis of randomized controlled trials. Clin Psychol Rev. 2018;59:30–40. https://doi.org/10.1016/j.cpr.2017.10.009.CrossRefPubMed

Hale AC, Bohnert KM, Ganoczy D, Sripada RK. Predictors of treatment adequacy during evidence-based psychotherapy for PTSD. Psychiatr Serv. 2019;70(5):367–73. https://doi.org/10.1176/appi.ps.201800361.CrossRefPubMed

Maguen S, Li Y, Madden E, Seal KH, Neylan TC, Patterson OV, et al. Factors associated with completing evidence-based psychotherapy for PTSD among veterans in a national healthcare system. Psychiatry Res. 2019;274:112–28. https://doi.org/10.1016/j.psychres.2019.02.027.CrossRefPubMed

Meis LA, Schaaf KW, Erbes CR, Polusny MA, Miron LR, Schmitz TM, et al. Interest in partner-involved services among veterans seeking mental health care from a VA PTSD clinic. Psychol Trauma Theory Res Pract Policy. 2013;5(4):334–42. https://doi.org/10.1037/a0028366.CrossRef

Baucom DH, Whisman MA, Paprocki C. Couple-based interventions for psychopathology: Couple-based interventions for psychopathology. J Fam Ther. 2012;34(3):250–70. https://doi.org/10.1111/j.1467-6427.2012.00600.x.CrossRef

10.

Byrne M, Carr A, Clark M. The efficacy of couples-based interventions for panic disorder with agoraphobia. J Family Therapy. 2004;26(2):105–25. https://doi.org/10.1111/j.1467-6427.2004.00273.x.CrossRef

11.

Meis LA, Griffin JM, Greer N, Jensen AC, MacDonald R, Carlyle M, et al. Couple and family involvement in adult mental health treatment: a systematic review. Clin Psychol Rev. 2013;33(2):275–86. https://doi.org/10.1016/j.cpr.2012.12.003.CrossRefPubMed

12.

Monson CM, Fredman SJ, Macdonald A, Pukay-Martin ND, Resick PA, Schnurr PP. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA. 2012;308(7):700–9. https://doi.org/10.1001/jama.2012.9307.CrossRefPubMedPubMedCentral

13.

Sautter FJ, Glynn SM, Cretu JB, Senturk D, Vaught AS. Efficacy of structured approach therapy in reducing PTSD in returning veterans: a randomized clinical trial. Psychol Serv. 2015;12(3):199–212. https://doi.org/10.1037/ser0000032.CrossRefPubMed

14.

Thompson-Hollands J, Lee DJ, Sloan DM. The use of a brief family intervention to reduce dropout among veterans in individual trauma-focused treatment: a randomized controlled trial. J Trauma Stress. 2021;34(4):829–39. https://doi.org/10.1002/jts.22680.CrossRefPubMed

15.

Meis LA, Noorbaloochi S, Hagel Campbell EM, Erbes CR, Polusny MA, Velasquez TL, et al. Sticking it out in trauma-focused treatment for PTSD: it takes a village. J Consult Clin Psychol. 2019;87(3):246–56. https://doi.org/10.1037/ccp0000386.CrossRefPubMedPubMedCentral

16.

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26. https://doi.org/10.1097/MLR.0b013e3182408812.CrossRefPubMedPubMedCentral

17.

March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R. The case for practical clinical trials in psychiatry. Am J Psychiatry. 2005;162(5):836–46. https://doi.org/10.1176/appi.ajp.162.5.836.CrossRefPubMed

18.

Morgenstern J, Hogue A, Dauber S, Dasaro C, McKay JR. A practical clinical trial of coordinated care management to treat substance use disorders among public assistance beneficiaries. J Consult Clin Psychol. 2009;77(2):257–69. https://doi.org/10.1037/a0014489.CrossRefPubMedPubMedCentral

19.

Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Jama. 2003;290(12):1624–32. https://doi.org/10.1001/jama.290.12.1624.CrossRefPubMed

20.

Hagedorn HJ, Stetler CB, Bangerter A, Noorbaloochi S, Stitzer ML, Kivlahan D. An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers. Addict Sci Clin Pract. 2014;9(1):1–5. https://doi.org/10.1186/1940-0640-9-12.CrossRef

21.

Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7. https://doi.org/10.2105/AJPH.89.9.1322.CrossRefPubMedPubMedCentral

22.

American Psychiatric Association. Diagnostic and statistical manual of mental disorders, (DSM-5). Arlington, VA: American Psychiatric Publishing; 2013. https://doi.org/10.1176/appi.books.9780890425596.CrossRef

23.

Weathers FW, Blake DD, Schnurr PP, Kaloupek DG, Marx BP, Keane TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) In: Assessment, DSM-5 Measures. National Center for PTSD. 2013; https://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp.

24.

Brancu M, Mann-Wrobel M, Beckham JC, Wagner HR, Elliott A, Robbins AT, et al. Subthreshold posttraumatic stress disorder: a meta-analytic review of DSM–IV prevalence and a proposed DSM–5 approach to measurement. Psychological Trauma: Theory, Research, Practice, and Policy. 2016;8(2):222–32. https://doi.org/10.1037/tra0000078.CrossRef

25.

First MB, Williams JBW, Spitzer RL, Gibbon M. Structured Clinical Interview for DSM-5 Disorders, Clinical Trials version (SCID-5-CT). Arlington, VA: American Psychiatric Publishing; 2015.

26.

Foa EB, Kozak MJ. Emotional processing and fear: exposure to corrective information. Psychol Bull. 1986;99(1):20–35. https://doi.org/10.1037/0033-2909.99.1.20.CrossRefPubMed

27.

Rauch S, Foa E. Emotional processing theory (EPT) and exposure therapy for PTSD. J Contemp Psychother. 2006;36(2):61–5. https://doi.org/10.1007/s10879-006-9008-y.CrossRef

28.

Foa E, Hembree E, Rothbaum B, Rauch S. Prolonged Exposure therapy for PTSD: emotional processing of traumatic experiences. 2nd ed. New York: Oxford University Press; 2019. https://doi.org/10.1093/med-psych/9780190926939.001.0001.CrossRef

29.

Acierno R, Gros DF, Ruggiero KJ, Hernandez-Tejada MA, Knapp RG, Lejuez CW, et al. Behavioral activation and therapeutic exposure for posttraumatic stress disorder: a noninferiority trial of treatment delivered in person versus home-based telehealth. Depression Anxiety. 2016;33(5):415–23. https://doi.org/10.1002/da.22476.CrossRefPubMed

30.

Acierno R, Knapp R, Tuerk P, Gilmore AK, Lejuez C, Ruggiero K, et al. A non-inferiority trial of Prolonged Exposure for posttraumatic stress disorder: In person versus home-based telehealth. Behav Res Ther. 2017;89:57–65. https://doi.org/10.1016/j.brat.2016.11.009.CrossRefPubMed

31.

Valentine LM, Donofry SD, Broman RB, Smith ER, Rauch SA, Sexton MB. Comparing PTSD treatment retention among survivors of military sexual trauma utilizing clinical video technology and in-person approaches. J Telemed Telecare. 2020;26(7-8):443–51. https://doi.org/10.1177/1357633X19832419.CrossRefPubMed

32.

Rubin R. VA using telemedicine to provide therapy to rural veterans with PTSD. JAMA. 2018;319(16):1648. https://doi.org/10.1001/jama.2018.4737.CrossRefPubMed

33.

Baucom DH, Shoham V, Mueser KT, Daiuto AD, Stickle TR. Empirically supported couple and family interventions for marital distress and adult mental health problems. J Consult Clin Psychol. 1998;66(1):53–88. https://doi.org/10.1037/0022-006X.66.1.53.CrossRefPubMed

34.

Miller WR, Rollnick S. Motivational interviewing: helping people change. New York: Guilford press; 2013.

35.

O’Farrell TJ, Fals-Stewart W. Behavioral couples therapy for alcoholism and drug abuse. New York: The Guilford Press; 2006.

36.

Fredman SJ, Vorstenbosch V, Wagner AC, Macdonald A, Monson CM. Partner accommodation in posttraumatic stress disorder: initial testing of the Significant Others’ Responses to Trauma Scale (SORTS). J Anxiety Disord. 2014;28(4):372–81. https://doi.org/10.1016/j.janxdis.2014.04.001.CrossRefPubMedPubMedCentral

37.

Eassom E, Giacco D, Dirik A, Priebe S. Implementing family involvement in the treatment of patients with psychosis: a systematic review of facilitating and hindering factors. BMJ Open. 2014;4(10) https://doi.org/10.1136/bmjopen-2014-006108.

38.

Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marz, B. P., Schnurr, P. P. The PTSD Checklist for DSM–5 (PCL-5). In: Assessment, DSM-5 Measures. National Center for PTSD. 2013. https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp. Accessed 12 Jan 2022.

39.

Simpson HB, Maher M, Page JR, Gibbons CJ, Franklin ME, Foa EB. Development of a patient adherence scale for exposure and response prevention therapy. Behav Ther. 2010;41(1):30–7. https://doi.org/10.1016/j.beth.2008.12.002.CrossRefPubMed

40.

Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. https://doi.org/10.1046/j.1525-1497.2001.016009606.x.CrossRefPubMedPubMedCentral

41.

Bonomi A, Patrick D. User’s manual and interpretation guide for the United States version of the World Health Organization Quality of Life (WHOQOL) Instrument. U.S. WHOQOL Center, Seattle: Seattle; 1997.

42.

Pierce GR, Sarason IG, Sarason BR. General and relationship-based perceptions of social support: are two constructs better than one? J Personal Soc Psychol. 1991;61(6):1028–39. https://doi.org/10.1037/0022-3514.61.6.1028.CrossRef

43.

Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50(2):179–211. https://doi.org/10.1016/0749-5978(91)90020-T.CrossRef

44.

Ajzen I. Perceived behavioral control, self-efficacy, locus of control, and the theory of planned behavior. Journal of Applied Social Psychology. 2002;32(4):665–83. https://doi.org/10.1111/j.1559-1816.2002.tb00236.x.CrossRef

45.

Meis LA, Noorbaloochi S, Hagel Campbell EM, Erickson EPG, Velasquez TL, Leverty DM, et al. A Theory of Planned Behavior scale for adherence to trauma-focused posttraumatic stress disorder treatments. Journal of Traumatic Stress. 2020;34(2):440–53. https://doi.org/10.1002/jts.22620.CrossRefPubMed

46.

Fekete EM, Stephens MAP, Druley JA, Greene KA. Effects of spousal control and support on older adults’ recovery from knee surgery. Journal of Family Psychology. 2006;20(2):302–10. https://doi.org/10.1037/0893-3200.20.2.302.CrossRefPubMed

47.

Stephens MAP, Clark S. Reciprocity in the expression of emotional support among later-life couples coping with stroke. In: Coping with chronic stress. Boston: Springer; 1997. p. 221–42.CrossRef

48.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–96. https://doi.org/10.2307/2136404.CrossRefPubMed

49.

Epstein NB, Baldwin LM, Bishop DS. The McMaster family assessment device. J Marital Fam Ther. 1983;9(2):171–80. https://doi.org/10.1111/j.1752-0606.1983.tb01497.x.CrossRef

50.

Kabacoff RI, Miller IW, Bishop DS, Epstein NB, Keitner GI. A psychometric study of the McMaster Family Assessment Device in psychiatric, medical, and nonclinical samples. J Fam Psychol. 1990;3(4):431–9. https://doi.org/10.1037/h0080547.CrossRef

51.

Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007;21(4):572–83. https://doi.org/10.1037/0893-3200.21.4.572.CrossRefPubMed

52.

Duncan B, Miller S, Sparks J, Claud D, Reynolds L, Brown J, et al. The Session Rating Scale: preliminary psychometric properties of a “working” alliance measure. J Brief Ther. 2003;3:3–12.

53.

Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. In: Annual convention of the international society for traumatic stress studies, San Antonio, TX, vol. 462; 1993.

54.

Monson CM, Gradus JL, Young-Xu Y, Schnurr PP, Price JL, Schumm JA. Change in posttraumatic stress disorder symptoms: do clinicians and patients agree? Psychol Assess. 2008;20(2):131–8. https://doi.org/10.1037/1040-3590.20.2.131.CrossRefPubMed

55.

Aziz MA, Kenford S. Comparability of telephone and face-to-face interviews in assessing patients with posttraumatic stress disorder. J Psychiatr Pract. 2004;10(5):307–13. https://doi.org/10.1097/00131746-200409000-00004.CrossRefPubMed

56.

Rohde P, Lewinsohn PM, Seeley JR. Comparability of telephone and face-to-face interviews in assessing axis I and II disorders. Am J Psychiatr. 1997;154(11):1593–8. https://doi.org/10.1176/ajp.154.11.1593.CrossRefPubMed

57.

Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih M-C, Resick PA, et al. Design of VA Cooperative Study #591: CERV-PTSD, Comparative effectiveness research in veterans with PTSD. Contemp Clin Trials. 2015;41:75–84. https://doi.org/10.1016/j.cct.2014.11.017.CrossRefPubMed

58.

Dillman DA, Smyth JD, Christian LM. Internet, phone, mail, and mixed-mode surveys: the tailored design method. 4th ed. Hoboken: Wiley; 2014.

59.

Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40(3):879–91. https://doi.org/10.3758/BRM.40.3.879.CrossRefPubMed

60.

Sobel ME. Asymptotic confidence intervals for indirect effects in structural equation models. Sociol Methodol. 1982;13:290–312. https://doi.org/10.2307/270723.CrossRef

61.

Hamilton A. Rapid qualitative analysis: Updates/Developments. In: Archives. Health Services Research & Development Cyber Seminars; 2020. https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID = 3846. Accessed 12 Jan 2022.

62.

Hamilton AB. Qualitative methods in rapid turn-around health services research. In: Archives. Health Services Research & Development Cyber Seminars; 2019. https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID = 780. Accessed 12 Jan 2022.

63.

Miles MB, Huberman AM, Saldaña J. Qualitative data analysis: a methods sourcebook. 4th ed. Thousand Oaks: Sage Publications, Inc; 2020.

64.

Kearney DJ, Simpson TL. Broadening the approach to posttraumatic stress disorder and the consequences of trauma. JAMA. 2015;314(5):453–5. https://doi.org/10.1001/jama.2015.7522.CrossRefPubMed

65.

Laws HB, Glynn SM, McCutcheon SJ, Schmitz TM, Hoff R. Posttraumatic stress symptom change after family involvement in veterans’ mental health care. Psychol Serv. 2018;15(4):520–8. https://doi.org/10.1037/ser0000200.CrossRefPubMed

66.

Meis LA, Barry RA, Kehle SM, Erbes CR, Polusny MA. Relationship adjustment, PTSD symptoms, and treatment utilization among coupled National Guard soldiers deployed to Iraq. J Fam Psychol. 2010;24(5):560–7. https://doi.org/10.1037/a0020925.CrossRefPubMed

67.

Spoont MR, Nelson DB, Murdoch M, Rector T, Sayer NA, Nugent S, et al. Impact of treatment beliefs and social network encouragement on initiation of care by VA service users with PTSD. Psychiatr Serv. 2014;65(5):654–62. https://doi.org/10.1176/appi.ps.201200324.CrossRefPubMed

68.

Presidential Task Force on Military Deployment Services, for Youth, Families and Service Members. The psychological needs of U.S. military service members and their families: a preliminary report. In: Council Policy Manual. American Psychological Association; 2007. https://www.apa.org/about/policy/military-needs. Accessed 12 Jan 2022.

69.

109th U.S. Congress. Public Law 109-461. In: VA Office of General Counsel. VA Office of General Counsel; 2006. https://www.va.gov/ogc/docs/pl109-461.pdf. Accessed 12 Jan 2022.

70.

Fournier RR. A trauma education workshop on posttraumatic stress. Health Soc Work. 2002;27(2):113–24. https://doi.org/10.1093/hsw/27.2.113.CrossRefPubMed

71.

Thompson-Hollands J, Strage M, DeVoe ER, Beidas RS, Sloan DM. Development of a brief adjunctive intervention for family members of veterans in individual PTSD treatment. Cogn Behav Pract. 2020;28(2):193–209. https://doi.org/10.1016/j.cbpra.2020.06.007.CrossRef

72.

Monson CM, Fredman SJ. Cognitive-Behavioral Conjoint Therapy for PTSD: harnessing the healing power of relationships. New York: Guilford Press; 2012.

73.

Thompson-Hollands J, Burmeister LB, Rosen CS, O’Dougherty M, Erickson EPG, Meis LA. Veterans with poor PTSD treatment adherence: exploring their loved ones’ experience of PTSD and understanding of PTSD treatment. Psychol Serv. 2019;18(2):216–26. https://doi.org/10.1037/ser0000389.CrossRefPubMed

Title: Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement
Authors: Laura A. Meis
Shirley M. Glynn
Michele R. Spoont
Shannon M. Kehle-Forbes
David Nelson
Carl E. Isenhart
Afsoon Eftekhari
Princess E. Ackland
Erin B. Linden
Robert J. Orazem
Andrea 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
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06183-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Considerations when introducing electronic patient-reported outcome data capture in multicentre oncology randomised controlled trials

Bronchiectasis - Exercise as Therapy (BREATH): rationale and study protocol for a multi-center randomized controlled trial

AMAZONE: prevention of persistent pain after breast cancer treatment by online cognitive behavioral therapy—study protocol of a randomized controlled multicenter trial

AZTEC—azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes

Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour—a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756)

Financially incentivized knowledge assessments to improve provider compliance with treatment guidelines: a cluster-randomized controlled trial