IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.

A randomized clinical trial comparing Interpersonal Psychotherapy with Prolonged Exposure for the treatment of PTSD in veterans.

Trauma-focused therapies are recommended as first-line treatments for posttraumatic stress disorder (PTSD), but many veterans do not complete or sufficiently respond to these treatments. Interpersonal Therapy (IPT) is a non-trauma focused approach that directly addresses the interpersonal and social impairments associated with PTSD. This two-site randomized controlled equivalence trial compared IPT with Prolonged Exposure (PE) in improving PTSD symptoms and interpersonal functioning in 109 veterans with PTSD. Secondary outcomes included functioning and quality of life. We hypothesized that IPT would be statistically equivalent to PE in reducing PTSD symptoms, and superior to PE in improving interpersonal functioning and secondary outcomes of work and social adjustment and quality of life. PTSD symptom severity decreased significantly in both treatments from pre- to post-treatment. Although IPT improved as much as PE and treatments did not differ significantly, the 95 % confidence interval for the difference between the groups did not fall completely within the margin of equivalence. IPT was not superior to PE in improvement in interpersonal functioning or on secondary outcomes. Findings from multi-level linear mixed models using longitudinal data (posttreatment, three and six month follow up) for the primary outcomes of PTSD and interpersonal functioning were consistent with the post-treatment analyses. Although statistically inconclusive in terms of equivalence, the comparable reduction in PTSD symptoms slightly favoring IPT suggests that IPT is an acceptable alternative to gold-standard trauma-focused treatments for veterans with PTSD.

Rationale, design, and methods of a two-site randomized controlled trial: Comparative effectiveness of two treatments for posttraumatic stress disorder in veterans.

PTSD is associated with serious problems in interpersonal functioning, including higher rates of marital conflict and divorce, disrupted relationships with family and friends, estrangement from others and social isolation. Cognitive behavioral and trauma focused treatments are effective for treating PTSD symptoms, but a substantial proportion of individuals, particularly veterans, with PTSD, do not engage, complete, or fully respond to these treatments, and the effects of these treatments on interpersonal functioning are unknown. There is a critical need for alternative treatments with established efficacy, and for treatments that directly address problems in relationship functioning. Interpersonal Psychotherapy for PTSD (IPT-PTSD) is a promising candidate for such a treatment. This paper describes the rationale, design, and methods of the first randomized controlled equivalence trial comparing IPT-PTSD with a first-line gold standard treatment for PTSD (Prolonged Exposure; PE) in the treatment of PTSD in veterans. Both treatments include up to 12 weekly individual sessions. Assessments were conducted at baseline, following sessions four and eight, end of treatment, and 3 and 6 months post-treatment. Primary hypotheses are that IPT-PTSD will be statistically equivalent to PE in reducing the severity of PTSD symptoms, and superior to PE in improving interpersonal functioning. Secondary hypotheses propose that IPT will be superior to PE in improving overall social adjustment and quality of life, and in reducing suicidal ideation. Findings from this study have the potential to improve treatment options for veterans struggling with PTSD and interpersonal problems.

Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. METHODS: Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. RESULTS: Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. CONCLUSIONS: IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.

Group interpersonal psychotherapy for low-income women with posttraumatic stress disorder.

The aim of this study was to assess the efficacy of group interpersonal psychotherapy (IPT) for low-income women with chronic posttraumatic stress disorder (PTSD) subsequent to interpersonal trauma. Non-treatment-seeking predominantly minority women were recruited in family planning and gynecology clinics. Individuals with interpersonal trauma histories (e.g., assault, abuse, and molestation) who met criteria for current PTSD (N=48) were randomly assigned to treatment or a wait list. Assessments were conducted at baseline, treatment termination, and 4-month follow-up; data analysis used a mixed-effects regression approach with an intent-to-treat sample. The results showed that IPT was significantly more effective than the wait list in reducing PTSD and depression symptom severity. IPT participants also had significantly lower scores than waitlist individuals on four interpersonal functioning subscales: Interpersonal Sensitivity, Need for Social Approval, Lack of Sociability, and Interpersonal Ambivalence.

An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial.

[Correction Notice: An Erratum for this article was reported in Vol 9(4) of Psychological Trauma: Theory, Research, Practice, and Policy (see record 2016-54154-001). In the article, the names of authors Adil Alaoui and Anas Belouali were misspelled as Adil Aloui and Anas Beloui respectively. All versions of this article have been corrected.] Objective: Veterans suffering from posttraumatic stress disorder (PTSD) may avoid or fail to follow through with a full course of face-to-face mental health treatment for a variety of reasons. We conducted a pilot effectiveness trial of an online intervention for veterans with current PTSD to determine the feasibility, safety, and preliminary effectiveness of an online writing intervention (i.e., Warriors Internet Recovery & EDucation [WIRED]) as an adjunct to face-to-face psychotherapy. Method: Veterans (N = 34) who had served in Iraq or Afghanistan with current PTSD subsequent to deployment-related trauma were randomized to Veterans Affairs (VA) mental health treatment as usual (TAU) or to treatment as usual plus the online intervention (TAU + WIRED). All research participants were recruited from the Trauma Services Program, VA Medical Center, Washington, DC. They completed baseline assessments as well as assessments 12 weeks and 24 weeks after the baseline assessment. The online intervention consisted of therapist-guided writing, using principles of prolonged exposure and cognitive therapy. The intervention was adapted from an evidence-based treatment used in The Netherlands and Germany for individuals who had been exposed to nonmilitary traumas. Results: In addition to showing that the online intervention was both feasible to develop and implement, as well as being safe, the results showed preliminary evidence of the effectiveness of the TAU + WIRED intervention in this patient population, with particular evidence in reducing PTSD symptoms of hyperarousal. Conclusion: With minor modifications to enhance the therapeutic alliance, this intervention should be tested in a larger clinical trial to determine whether this method of online intervention might provide another alternative to face-to-face treatment for veterans with PTSD. (PsycINFO Database Record

Outcomes from the Moving Beyond Cancer psychoeducational, randomized, controlled trial with breast cancer patients.

PURPOSE: Evidence suggests that the re-entry phase (ie, early period after medical treatment completion) presents distinct challenges for cancer patients. To facilitate the transition to recovery, we conducted the Moving Beyond Cancer (MBC) trial, a multisite, randomized, controlled trial of psychoeducational interventions for breast cancer patients. METHODS: Breast cancer patients were registered within 6 weeks after surgery. After medical treatment, they completed baseline measures and were randomly assigned to standard National Cancer Institute print material (CTL); standard print material and peer-modeling videotape (VID); or standard print material, videotape, two sessions with a trained cancer educator, and informational workbook (EDU). Two primary end points were examined: energy/fatigue and cancer-specific distress. Secondary end points were depressive symptoms and post-traumatic growth. Perceived preparedness for re-entry was analyzed as a moderator of effects. RESULTS: Of 558 women randomly assigned to treatment, 418 completed the 6-month assessment and 399 completed the 12-month assessment. In analyses controlling for study site and baseline depressive symptoms, VID produced significant improvement in energy/fatigue at 6 months relative to CTL, particularly among women who felt less prepared for re-entry at baseline. No significant main effect of the interventions emerged on cancer-specific distress, but EDU prompted greater reduction in this outcome relative to CTL at 6 months for patients who felt more prepared for re-entry. Between-group differences in the primary outcomes were not significant at 12 months, and no significant effects emerged on the secondary end points. CONCLUSION: A peer-modeling videotape can accelerate the recovery of energy during the re-entry phase in women treated for breast cancer, particularly among those who feel less prepared for re-entry.

One-year outcomes of a randomized clinical trial treating depression in low-income minority women.

This study examines 1-year depressive symptom and functional outcomes of 267 predominantly lowincome, young minority women randomly assigned to antidepressant medication, group or individual cognitive- behavioral therapy (CBT), or community referral. Seventy-six percent assigned to medications received 9 or more weeks of guideline-concordant doses of medications; 36% assigned to psychotherapy received 6 or more CBT sessions. Intent-to-treat, repeated measures analyses revealed that medication (p=.001) and CBT (p=.02) were superior to community referral in lowering depressive symptoms across 1-year follow-up. At Month 12, 50.9% assigned to antidepressants, 56.9% assigned to CBT, and 37.1% assigned to community referral were no longer clinically depressed. These findings suggest that both antidepressant medications and CBT result in clinically significant decreases in depression for low-income minority women.

A Pilot Study of Interpersonal Psychotherapy for PTSD in Women Veterans.

OBJECTIVE: This pilot study aimed to determine whether interpersonal psychotherapy (IPT) for posttraumatic stress disorder (PTSD) would be effective with a sample of women veterans who experienced military-related PTSD. METHOD: Women veterans presenting for mental health services through the Trauma Services Program at the Washington, DC, Veterans Affairs Medical Center (VAMC) were referred to the study by Veterans Affairs (VA) clinicians if they experienced trauma during their military service and scored > 35 on the PTSD Checklist-Military Version. A total of 20 women completed a baseline assessment and were referred to treatment, the first trial of this treatment method with a veteran sample. Of the 15 women veterans who started treatment, 10 completed a trial of 12 individual sessions. Assessments were conducted posttreatment and at three months posttreatment follow-up. RESULTS: There was a significant decline in PTSD symptom severity from baseline to posttreatment, and these gains were maintained at three-month follow-up. Approximately one-third of the group no longer met full criteria for PTSD diagnosis, results that are comparable to studies of evidence-based treatments for PTSD (prolonged exposure and cognitive processing therapy) in military samples. CONCLUSIONS: IPT, a non-trauma-focused intervention that aims to increase social support and improve interpersonal functioning, shows promise as another means of addressing PTSD in veterans. It should be tested in a larger sample to determine if IPT for PTSD might serve as an alternative for veterans who would prefer a non-trauma-focused intervention to address their difficulties.

Effects of adolescent trauma exposure on risky behavior in college women.

Individuals with sexual assault or abuse histories are likely to engage in risky sexual and other self-destructive behaviors. Studies of these behaviors, however, have focused on target traumatic events without accounting for other events in the participant's history, recency of the events, and/or developmental level at time of occurrence. The present study addressed some of these confounds by creating groups with unique and non-overlapping trauma histories among adolescent participants whose first trauma occurred at age 12 or older. Sophomore women from six regional campuses were screened in a two-stage procedure, and 209 of 363 final interviewees were included in the present report. These were assigned to a no trauma group, or to one of five groups with a unique trauma history: a single traumatic loss, a single physical assault, a single sexual assault, ongoing sexual or physical abuse, or multiple single traumas. Risky sexual behavior, suicidal ideation, and elevated perpetration of violence were most prominent among those with ongoing abuse exposure, although a single exposure to interpersonal violence during adolescence was sufficient for some risky behaviors. Major depression (MDD) and posttraumatic stress disorder (PTSD) were associated with many of the behaviors, and may serve to heighten risk.

Recruitment and retention challenges in breast cancer survivorship research: results from a multisite, randomized intervention trial in women with early stage breast cancer.

The Moving Beyond Cancer trial is a multisite randomized, controlled trial of an individualized psychoeducational intervention for women with early stage breast cancer. Recruitment early in the cancer trajectory and assessment of retention at multiple points are notable features of the research, offering a unique opportunity to examine recruitment, retention, and predictors of participation. Patients were registered for the study within 6 weeks after definitive surgery and followed until primary medical treatment completion, whereupon they were enrolled, administered baseline measures, and randomized to one of three arms. Of 2,242 women referred, 41% were ineligible. Of eligible women, 42% elected participation through the point of randomization (n = 558). Participants did not differ from nonparticipants on initial self-reported physical functioning and mental health status, employment status, cancer history, cancer treatment plan, or previous cancer-related research participation. Women who were over 65 years of age, of racial minority status, unmarried, or less educated were less likely to participate through the point of randomization. Thus, several patient characteristics predicted trial participation, indicating the need for targeted recruitment attempts.

Treatment expectancies, patient alliance, and outcome: further analyses from the National Institute of Mental Health Treatment of Depression Collaborative Research Program.

Prior analyses from the National Institute of Mental Health Treatment of Depression Collaborative Research Program indicated that patients' expectancies of treatment effectiveness (S. M. Sotsky et al., 1991) and the quality of the therapeutic alliance (J. L. Krupnick et al., 1996) predicted clinical improvement. These data were reanalyzed to examine the hypothesis that the link between treatment expectancies and outcome would be mediated by patients' contribution to the alliance. Among 151 patients who completed treatment, this hypothesis was supported, suggesting that patients who expect treatment to be effective tend to engage more constructively in session, which helps bring about symptom reduction. Therapists' expectancies for patient improvement also predicted outcome, although this association was not mediated by the alliance. None of the expectancy scales interacted with alliance ratings in the prediction of clinical improvement.

Mental health effects of adolescent trauma exposure in a female college sample: exploring differential outcomes based on experiences of unique trauma types and dimensions.

Most studies on the psychological impact of trauma exposure focus on the response to a single type of trauma, with little or no attention paid to the contribution of prior traumatic experiences. The goal of this study was to disentangle some of the confounding effects of multiple trauma exposures by exploring the unique contribution to mental health outcomes made by specific types and dimensions of trauma. This report compares the psychological outcomes of college women who experienced different types of trauma during adolescence, including traumatic bereavement, sexual assault, and physical assault. Young women who had experienced a single event of one of these types were compared with peers who had experienced multiple single events, ongoing sexual and/or physical abuse, as well as those who had experienced no trauma. Results, based on structured clinical interviews, and self-report measures showed that there were some significant differences in mental health outcomes based on trauma type. However, trauma exposure versus no exposure and the cumulative effects of exposure versus one-time experiences played the key roles in differentiating the groups.

Patterns of care in early-stage breast cancer survivors in the first year after cessation of active treatment.

PURPOSE: Patterns of health care use have not been well described for breast cancer survivors. The purpose of this study was to describe the health service use in a survivor cohort. PATIENTS AND METHODS: Women with stage I or II breast cancer were recruited (n = 558) after primary treatment for a multicenter, randomized trial of psychoeducational interventions for facilitating transition to survivorship; 418 women completed the study. Participants completed calendar diaries detailing health care use for 1 year after treatment. Services were coded using Current Procedural Terminology-Fourth Edition codes; costs were estimated using year 2000 Medicare reimbursements. RESULTS: Health care use diary data were available for 391 women (70% of the sample). On average, these survivors reported 30 episodes of health service use in the year after treatment. Total annual costs of care averaged more than 1,800 dollars per survivor; medical office visits were the major component of costs. Type of cancer treatment, depression, and physical function and comorbid illness were independent predictors of the costs of services. There were geographic variations in initial local treatment patterns and in post-treatment costs. Notably, all women should have received surveillance mammography in the time period, but only 61.9% did so; the odds of mammogram receipt were higher for women who had a lumpectomy (v mastectomy) and women who were white (v nonwhite). CONCLUSION: Use of health services is frequent and intensive in the first year after treatment for breast cancer. Despite frequent contact with the health care system, there is room for improvement in providing guideline-suggested surveillance mammography for survivors.

Impact of PTSD comorbidity on one-year outcomes in a depression trial.

Low-income African American, Latino, and White women were screened and recruited for a depression treatment trial in social service and family planning settings. Those meeting full criteria for major depression (MDD; N = 267) were randomized to cognitive-behavior therapy (CBT), antidepressant medication, or community mental health referral. All randomly assigned participants were evaluated by baseline telephone and clinical interview, and followed by telephone for one year. Posttraumatic stress disorder (PTSD) comorbidity was assessed at baseline and one-year follow-up in a clinical interview. At baseline, 33% of the depressed women had current comorbid PTSD. These participants had more exposure to assaultive violence, had higher levels of depression and anxiety, and were more functionally impaired than women with depression alone. Depression in both groups improved over the course of one year, but the PTSD subgroup remained more impaired throughout the one-year follow-up period. Thus, evidence-based treatments (antidepressant medication or structured psychotherapy) decrease depression regardless of PTSD comorbidity, but women with PTSD were more distressed and impaired throughout. Including direct treatment of PTSD associated with interpersonal violence may be more effective in alleviating depression in those with both diagnoses.

Promoting adjustment after treatment for cancer.

The transition from the period of diagnosis and medical treatment of cancer to survivorship (i.e., the reentry phase) is an understudied phase in the cancer trajectory. The objectives of this report were 1) to illustrate several adaptive tasks of the reentry phase, 2) to provide examples of research on factors that predict positive adjustment during this phase, and 3) to discuss interventions that address the adaptive tasks of early cancer survivorship. Although the pertinent empirical literature is scarce, accounts from cancer survivors, healthcare professionals, and qualitative researchers converge to suggest several themes in adaptive tasks during reentry. Drawing from the authors' work and that of others, the authors have described common expectancies held by many individuals approaching reentry (e.g., "I shouldn't need support"), typical concerns during this phase (e.g., concern over cancer recurrence), and personal and contextual factors that can facilitate and hinder adjustment. Promising psychosocial interventions have been developed for individuals in the reentry period. Continued research will be necessary to characterize this important phase of cancer survivorship.

Brief psychodynamic treatment of PTSD.

This article describes a brief psychodynamic psychotherapy for adults suffering from PTSD following exposure to a single traumatic event, such as tragic bereavement, assault, or loss of a body part through surgery. It uses a supportive therapeutic relationship to uncover what the specific event and circumstances that follow mean to the individual and the obstacles to normal psychological processing of these events. Using this 12-session treatment model, therapists pay particular attention to the individual's current phase of response and the typical ways that the individual avoids threatening information. Making links among the recent trauma, earlier developmental experiences that may have rendered the individual vulnerable to the development of PTSD, and ways that conflicts are reenacted in the therapeutic dyad, dynamic therapists seek to help traumatized individuals re-establish a sense of coherence and meaning in their lives. A case illustration is provided to demonstrate the phases and techniques in this approach.

Quality of life at the end of primary treatment of breast cancer: first results from the moving beyond cancer randomized trial.

BACKGROUND: During the last decade, survival rates for breast cancer have increased as a result of earlier detection and increased use of adjuvant therapy. Limited data exist on the psychosocial aspects of the transitional period between the end of primary treatment and survivorship. We investigated the baseline psychosocial status of women enrolled in a randomized trial testing two psychosocial interventions for women at the end of primary treatment. METHODS: Participants, identified within 1 month after surgery (registration), provided demographic information and limited measures of quality of life. They were followed until they finished primary treatment (enrollment), at which time they completed a mailed baseline survey that included standardized measures of quality of life (including standardized scales of physical and emotional functioning), mood, symptoms, and sexual functioning. A total of 558 patients (mean age = 56.9 years) were enrolled in the study between July 1, 1999, and June 30, 2002. Health outcomes were examined according to treatment received: mastectomy with and without chemotherapy, and lumpectomy with and without chemotherapy. All statistical tests were two-sided. RESULTS: Among all treatment groups, patients who had a mastectomy had the poorest physical functioning at registration (P<.001) and at enrollment (P=.05). At enrollment, mood and emotional functioning were similar among all patients, with no differences by type of treatment received. At enrollment, symptoms, including muscle stiffness, breast sensitivity, aches and pains, tendency to take naps, and difficulty concentrating, were common among patients in all groups and were statistically significantly associated with poor physical functioning and emotional well-being. Sexual functioning was worse for women who received chemotherapy than for those who did not, regardless of type of surgery (P<.001). CONCLUSIONS: At the end of primary treatment for breast cancer, women in all treatment groups report good emotional functioning but report decreased physical functioning, particularly among women who have a mastectomy or receive chemotherapy. Clinical interventions to address common symptoms associated with treatment should be considered to improve physical and emotional functioning at the end of primary treatment for breast cancer.