Dropout in a clinical trial for comorbid PTSD and MDD among US service members: Are pretreatment characteristics predictive?

OBJECTIVE: Despite effective treatment options for posttraumatic stress disorder (PTSD), many patients do not complete therapy. This includes U.S. active duty service members, yet factors linked to attendance in this population remain understudied and dropout remains difficult to predict. Additionally, most studies have not examined samples with PTSD and co-occurring major depressive disorder (MDD) despite high rates of comorbidity. METHOD: The current study explored predictors of dropout among service members with comorbid PTSD and MDD (N = 94) randomized to cognitive processing therapy enhanced with behavioral activation (BA + CPT) or CPT as part of a clinical trial. RESULTS: Using the Fournier approach, only two predictors were associated with lower dropout risk among over 20 examined: shorter duration between pretreatment assessment and Session 1 (p = .041) and past 3-month PTSD treatment engagement (p = .036). CONCLUSION: Results suggest the possible utility of early momentum in starting therapy and leveraging recent treatment to improve attendance. However, this study also highlights the possible limitations of commonly assessed pretreatment factors in predicting attendance and current challenges in measuring dropout risk. Strategies to improve prediction, such as shifting focus to assess modifiable factors and processes more proximal to dropout during treatment, may be needed.Trial registration: ClinicalTrials.gov identifier: NCT02874131.

Gender Differences in Psychological Outcomes Following Surf versus Hike Therapy among U.S. Service Members.

BACKGROUND: Surf and hike therapies have demonstrated effectiveness as adjunct interventions for service members with major depressive disorder (MDD). This study explores gender differences in intervention outcomes following a pragmatic, randomized controlled trial of Surf and Hike Therapy for service members with MDD (N = 96; men, n = 46; women, n = 50). METHODS: Clinician-administered and self-report measures (depression, anxiety, positive affect, negative affect, resilience, and pain) were completed at preprogram, postprogram, and 3-month follow-up; brief measures (depression/anxiety and positive affect) were completed before and after each session. RESULTS: Multilevel modeling results showed that anxiety decreased from pre- to postprogram and significantly differed by gender (B = -2.26, p = 0.029), with women reporting greater reductions. The remaining outcomes from pre- to postprogram demonstrated significant improvements that did not differ by gender (ps = 0.218-0.733). There were no gender differences through follow-up (ps = 0.119-0.780). However, within sessions, women reported greater improvements in depression/anxiety (B = -0.93, p = 0.005) and positive affect (B = 3.73, p = 0.001). The change in positive affect scores within sessions was greater for women in Hike Therapy compared to men (p = 0.016). CONCLUSIONS: Overall, results demonstrate that both genders benefit from adjunctive Surf and Hike Therapies, but women exhibit a better response in terms of longer-term anxiety and immediate psychological outcomes.

The effectiveness of the National Veterans Summer Sports Clinic for veterans with probable posttraumatic stress disorder.

Introduction: Recreational and adaptive sports programs may be beneficial therapeutic interventions for improving psychological outcomes among veterans and service members with posttraumatic stress disorder (PTSD) because they provide opportunities for exercise, socialization, respite, and time outdoors. Although there are an increasing number of sports programs for veterans and service members with PTSD, data evaluating the outcomes of such programs are limited. Materials and methods: The sample included 74 U.S. veterans who participated in the National Veterans Summer Sports Clinic (NVSSC), an annual, week-long adaptive sports program in San Diego, California. Participants were categorized into two subgroups: those who met criteria for probable PTSD using the PTSD Checklist for DSM-5 (n = 20) and those who did not (n = 54). Participants completed self-report assessments before and after each daily activity, before and after the program, and 3 months following program completion. Results: Over the course of NVSSC program participation, the diagnostic subgroups (probable PTSD vs. no PTSD) did not significantly differ on changes in depression, positive affect, negative affect, or insomnia. Compared to those without PTSD, veterans with PTSD experienced greater reduction in generalized anxiety during the program (MD = -3.07, p = 0.034). Veterans with PTSD also experienced significant improvements in PTSD symptoms at postprogram (MD = -23.76, p < 0.001). For both groups, significant benefits were shown during the program but rebounded by the 3-month follow-up. Over the course of each daily activity, positive affect (MD = 2.71, p < 0.001) and depression/anxiety scores significantly decreased (MD = -0.75, p < 0.001), with no differences between PTSD diagnostic groups across time (ps = 0.714 and 0.961, respectively). Conclusion: Veterans with and without PTSD benefited from participation in the NVSSC. Participants with probable PTSD experienced greater improvements in generalized anxiety at postprogram only; there were no other significant differences between the two groups at postprogram or at 3-month follow-up. In line with prior research, benefits for those with PTSD were lost by 3-month follow-up, suggesting that regular engagement in recreational and adaptive sports may be necessary to sustain psychological health improvements.

Comparison of behavioral activation-enhanced cognitive processing therapy and cognitive processing therapy among U.S. service members: A randomized clinical trial.

Posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) frequently co-occur and can cause significant impairment. Data are lacking as to whether interventions targeting both PTSD and MDD may improve treatment outcomes among individuals with this comorbidity compared with existing evidence-based PTSD treatments alone. This randomized trial compared the effectiveness of cognitive processing therapy (CPT) enhanced with behavioral activation (BA+CPT) versus CPT among 94 service members (52 women and 42 men; age M = 28.5 years) with comorbid PTSD and MDD. The primary outcome was clinician-administered depression symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS) from pretreatment through 3-month follow-up. Intent-to-treat analyses using multilevel models showed statistically and clinically significant decreases in MADRS scores for both conditions over time, with no significant differences between BA+CPT and CPT. Secondary depression and PTSD symptom outcomes followed a similar pattern of results. For diagnostic MDD and PTSD outcomes using available data, no statistically significant differences between treatments emerged at posttreatment or 3-month follow-up. Sessions attended, dropout rate, and treatment satisfaction did not significantly differ between treatments. Outcomes were comparable for both treatments, suggesting that BA+CPT and CPT were similarly effective psychotherapy options for comorbid PTSD and MDD.

Psychological and functional outcomes following a randomized controlled trial of surf and hike therapy for U.S. service members.

Introduction: Exercise-based interventions have established benefits for the treatment of depression and other psychological outcomes; however, limited data exist evaluating psychological, social, and functional outcomes for exercise outdoors. Methods: The current study sought to expand knowledge about the breadth of effects following outdoor exercise interventions by using data from a randomized control trial comparing Surf and Hike Therapy among 96 U.S. active duty service members with major depressive disorder (MDD). Assessments examining psychological symptoms and functioning were completed before and after the 6-week programs, and 3 months following program completion. Participants also completed assessments before and after each exercise session. Multilevel modeling was used to determine whether psychological and functional outcomes (anxiety, positive and negative affect, resilience, pain, and physical and social functioning) improved for service members receiving Surf or Hike Therapy, and whether improvements differed by intervention. Results: Study findings showed improved anxiety (p < 0.001), negative affect (p < 0.001), psychological resilience (p = 0.013), and social functioning (p < 0.001) following program participation, with no differences by intervention. Positive affect, pain, and physical functioning did not significantly improve after the program. Within sessions, positive affect (p < 0.001) and pain (p = 0.036) changed, and to a greater extent for those in the Surf Therapy condition. Conclusion: Study results suggest that both Surf Therapy and Hike Therapy can improve psychological symptoms and social functioning impairments that commonly co-occur among service members with MDD, but Surf Therapy may provide enhanced immediate effects on positive affect and pain. Clinical trial registration: ClinicalTrials.gov, NCT03302611.

A randomized controlled trial of surf and hike therapy for U.S. active duty service members with major depressive disorder.

BACKGROUND: Major depressive disorder (MDD) is the most prevalent mental health disorder worldwide, including among U.S. service members. In addition to evidence-based treatments, activity-based approaches have been shown to effectively treat depressive symptoms, particularly when they occur in the natural environment. METHODS: This study compared two activity-based interventions, Surf Therapy and Hike Therapy, on depression outcomes among 96 active duty service members with MDD. Participants were randomized to 6 weeks of Surf or Hike Therapy. Clinician-administered and self-report measures were completed at preprogram, postprogram, and 3-month follow-up. A brief depression/anxiety measure was completed before and after each activity session. RESULTS: Multilevel modeling results showed that continuous depression outcomes changed significantly over time (ps < .001). Although service members in Hike Therapy reported higher average depression scores than those in Surf Therapy, the trajectory of symptom improvement did not significantly differ between groups. Regarding MDD diagnostic status, there were no significant differences between the groups at postprogram (p = .401), but Surf Therapy participants were more likely to remit from MDD than were those in Hike Therapy at the 3-month follow-up (p = .015). LIMITATIONS: The sample consisted of service members, so results may not generalize to other populations. Most participants received concurrent psychotherapy or pharmacotherapy, and, although statistically accounted for, results should be interpreted in this context. CONCLUSIONS: Both Surf and Hike Therapies appear to be effective adjunctive interventions for service members with MDD. Research is needed to examine the effectiveness of these therapies as standalone interventions. TRIAL REGISTRATION: Clinical trials registration number NCT03302611; First registered on 05/10/2017.

Rural-urban disparities in the nutritional status of younger adolescents in Tanzania.

Research on geographic differences in health focuses largely on children less than five years; little is known about adolescents-and even less regarding younger adolescents-a vulnerable group at a critical stage of the life course. Africa's rapid population growth and urbanization rates, coupled with stagnant rates of undernutrition, further indicate the need for country-specific data on rural-urban health disparities to inform development policies. This study examined rural-urban disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among younger adolescents in Tanzania. Participants were randomly selected adolescents aged 10-14 years (N = 1,125) residing in Kilosa (rural) and Moshi (urban) districts of Tanzania. Individual and household-level data were collected using surveys and anthropometric data was collected on all adolescents. Age, sex, household living conditions, and assets were self-reported. BAZ and HAZ were calculated using the WHO reference guide. The prevalence of undernutrition was 10.9% among rural and 5.1% among urban adolescents (p<0.001). Similarly, stunting prevalence was greater in rural (64.5%) than urban (3.1%) adolescents (p<0.001). After adjusting for covariates, rural residence was significantly and inversely associated with BAZ (B = -0.29, 95% CI: -0.52, -0.70, p = 0.01), as well as with HAZ (B = -1.79, 95% CI: -2.03, -1.54, p<0.001). Self-identified males had lower BAZ (B = -0.23, 95% CI: -0.34, -0.11, p<0.001) and HAZ (B = -0.22, 95% CI: -0.35, -0.09, p = 0.001) than self-identified female adolescents. Rural-urban disparities in nutritional status were significant and gendered. Findings confirm place of residence as a key determinant of BAZ and HAZ among younger adolescents in Tanzania. Targeted gender-sensitive interventions are needed to limit growth faltering and improve health outcomes in rural settings.

Gender Differences in Psychological Outcomes Following Surf Therapy Sessions among U.S. Service Members.

Surf therapy is increasingly being used as an intervention to address various health problems, including psychological symptoms. Although recent research supports the positive impact of surf therapy on psychological outcomes, it is unclear whether these outcomes differ between men and women. This study compared changes in depression/anxiety (Patient Health Questionnaire-4), positive affect (Positive and Negative Affect Schedule), and pain (Numerical Pain Rating Scale) between U.S. service men and women (N = 74) during six weekly surf therapy sessions. Overall, participants reported decreased depression/anxiety (p < 0.001) and increased positive affect (p < 0.001), but no change in pain rating following each session (p = 0.141). Significant gender differences were found in the magnitude of changes in depression/anxiety (B = -1.01, p = 0.008) and positive affect (B = 4.53, p < 0.001) during surf sessions, despite no differences in pre-session scores on either outcome. Women showed greater improvements in depression/anxiety and positive affect compared with men-an important finding, given that surfing and military environments are often socially dominated by men. Future research is needed to replicate these findings in other samples, extend this research to other underrepresented populations, and identify barriers and facilitators of the sustainable implementation of surf therapy across populations.

Comparison of surf and hike therapy for active duty service members with major depressive disorder: Study protocol for a randomized controlled trial of novel interventions in a naturalistic setting.

Many active duty service members suffer from major depressive disorder (MDD). Although traditional treatments exist, alternative approaches may also be effective in treating depressive symptoms. Previous research has shown that physical activity has significant positive effects on depression symptoms in individuals with MDD, and that these benefits may be enhanced when physical activity occurs in a natural environment. Even though physical activity (i.e., hiking, walking) in natural environments has been shown to reduce depressive symptoms, water-based activity occurring in a natural environment (e.g., surfing) may produce even greater improvements in depressive symptoms. We detail an ongoing randomized controlled trial (RCT) comparing the efficacy of surf therapy and hike therapy with respect to immediate and longer-term psychological, physical, and functional outcomes in active duty service members with MDD. We describe the methodological development of this RCT evaluating novel treatment approaches and discuss considerations for evaluating physical activity interventions in a naturalistic setting.

Evaluation of an integrated treatment for active duty service members with comorbid posttraumatic stress disorder and major depressive disorder: Study protocol for a randomized controlled trial.

Posttraumatic stress disorder (PTSD) commonly co-occurs with major depressive disorder (MDD) in both civilian and military/veteran populations. Existing, evidence-based PTSD treatments, such as cognitive processing therapy (CPT), often reduce symptoms of both PTSD and depression; however, findings related to the influence of comorbid MDD on PTSD treatment outcomes are mixed, and few studies use samples of individuals with both conditions. Behavioral activation (BA), an approach that relies on behavioral principles, is an effective treatment for depression. We have integrated BA into CPT (BA+CPT), a more cognitive approach, to address depressive symptoms among active duty service members with both PTSD and comorbid MDD. We describe an ongoing randomized controlled trial investigating the efficacy of our innovative, integrated BA+CPT intervention, compared with standard CPT, for active duty service members with PTSD and comorbid MDD. We detail the development of this integrated treatment, as well as the design and implementation of the randomized controlled trial, to evaluate its effect on symptoms.