Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial.
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SUBMITTER: Powers MB
PROVIDER: S-EPMC8113811 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background: It is unclear whether the evidence-based treatments for PTSD are as effective in patients with CA-PTSD. Objective: We aimed to investigate the effectiveness of three variants of prolonged exposure therapy. Method: We recruited adults with CA-PTSD. Participants were randomly assigned to Prolonged Exposure (PE; 16 sessions in 16 weeks), intensified Prolonged Exposure (iPE; 12 sessions in 4 weeks followed by 2 booster sessions) or a phase-based treatment, in which 8 sessions of PE were preceded by 8 sessions of Skills Training in Affective and Interpersonal Regulation (STAIR+PE; 16 sessions in 16 weeks). Assessments took place in week 0 (baseline), week 4, week 8, week 16 (post-treatment) and at a 6-and 12-month follow-up. The primary outcome was clinician-rated PTSD symptom severity. Results: We randomly assigned 149 patients to PE (48), iPE (51) or STAIR+PE (50). All treatments resulted in large improvements in clinician assessed and self-reported PTSD symptoms from baseline to 1-year follow-up (Cohen's d > 1.6), with no significant differences among treatments. iPE led to faster initial symptom reduction than PE for self-report PTSD symptoms (t135 = -2.85, p = .005, d = .49) but not clinician-assessed symptoms (t135 = -1.65, p = .10) and faster initial symptom reduction than STAIR+PE for self-reported (t135 = -4.11, p < .001, d = .71) and clinician-assessed symptoms (t135 = -2.77, p = .006, Cohen's d = .48) STAIR+PE did not result in significantly more improvement from baseline to 1-year follow-up on the secondary outcome emotion regulation, interpersonal problems and self-esteem compared to PE and iPE. Dropout rates did not differ significantly between conditions. Conclusions: Variants of exposure therapy are tolerated well and lead to large improvements in patients with CA-PTSD. Intensifying treatment may lead to faster improvement but not to overall better outcomes. The trial is registered at the clinical trial registry, number NCT03194113, https://clinicaltrials.gov/ct2/show/NCT03194113.
| S-EPMC8500700 | biostudies-literature
Project description:ObjectiveTo examine the efficacy and maintenance of developmentally adapted prolonged exposure therapy for adolescents (PE-A) compared with active control time-limited dynamic therapy (TLDP-A) for decreasing posttraumatic and depressive symptoms in adolescent victims of single-event traumas.MethodThirty-eight adolescents (12 to 18 years old) were randomly assigned to receive PE-A or TLDP-A.ResultsBoth treatments resulted in decreased posttraumatic stress disorder and depression and increased functioning. PE-A exhibited a greater decrease of posttraumatic stress disorder and depression symptom severity and a greater increase in global functioning than did TDLP-A. After treatment, 68.4% of adolescents beginning treatment with PE-A and 36.8% of those beginning treatment with TLDP-A no longer met diagnostic criteria for posttraumatic stress disorder. Treatment gains were maintained at 6- and 17-month follow-ups.ConclusionsBrief individual therapy is effective in decreasing posttraumatic distress and behavioral trauma-focused components enhance efficacy. CLINICAL TRIAL REGISTRY INFORMATION: Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents, URL: http://clinicaltrials.gov, unique identifier: NCT00183690.
| S-EPMC2945239 | biostudies-literature
Project description:IntroductionThere is a considerably large group of community-dwelling spinal cord injury (SCI) survivors living with low quality of life. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a Physical-Psychological Integrative (PPI) online group intervention on community-dwelling SCI survivors' physical activity, depression, and chronic pain.MethodsThis is a two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 3-month follow-up) design. Seventy-two participants will be randomly assigned to two study groups. The PPI intervention group will receive a video program for physical activity training and eight-week online group psychological interventions using skills of group-based motivational interviewing and mindfulness-based stress reduction. The control group will receive an eight-week online didactic education programed. Focus-group interviews will be conducted post-intervention to explore their views about acceptance and suggested improvements to the intervention. The feasibility of study procedures and the acceptability of interventions will be evaluated. The effectiveness of the PPI intervention will be evaluated by leisure-time physical activity, depression, chronic pain, exercise efficacy, mindfulness, and quality of life. We will use the generalized estimating equation to assess intervention effects and content analysis for interview data. This study has received ethical approval from the Hong Kong Polytechnic University (HSEARS20210705004) and was registered in ClinicalTrials.gov (NCT05535400).DiscussionThis study will be the first to provide empirical data on the evaluation of an online-group intervention integrating both physical activity promotion and psychological approaches, aimed at reducing physical inactivity, depression, and chronic pain for community-dwelling SCI survivors in Hong Kong. The findings could provide evidence supporting the use of PPI intervention as a novel online group support, in addressing both the physical and psychological needs of community-dwelling SCI survivors.
| S-EPMC10027219 | biostudies-literature
Project description:BackgroundMany people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI.MethodsThe Spinal Cord Injury Program in Exercise (SCIPE) study is a three-arm adaptive randomized controlled trial examining two 8-week teleexercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), compared to Attention Control (AC) in 327 adults with SCI. The primary outcome is change in physical activity level at post 8-week intervention. The study contains two interim analyses. The first interim analysis will assess feasibility metrics of the protocol after 36 participants complete the 8-week intervention period. The second interim analysis will examine two effectiveness comparisons: SET vs. AC and M2M vs AC, after 165 participants complete the intervention period. Early termination of the intervention arm(s) will take place when non-significant findings are found in the corresponding intervention(s). Incorporation of such interim analysis enhances trial efficiency by dropping the intervention(s) that deemed ineffective. It provides ethical benefits and allows allocation of additional resources to explore the effective intervention(s).DiscussionDelivery of teleexercise programs may be an effective strategy for addressing transportation barrier to exercise resources and increasing physical activity level and quality of life in people with SCI.Trial registrationClinicalTrials.gov Identifier NCT03925077 . Registered trial name: Spinal Cord Injury Program in Exercise (SCIPE). Registered on April 23rd, 2019.
| S-EPMC8377865 | biostudies-literature
Project description:BackgroundRehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise.Methods/designA multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011.DiscussionThe results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury.Trial registrationNCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).
| S-EPMC3848453 | biostudies-literature
Project description:The pathogenesis of spinal cord injury (SCI) remains poorly understood and treatment remains limited. Emerging evidence indicates that post-SCI inflammation is severe but the role of reactive astrogliosis not well understood given its implication in ongoing inflammation as damaging or neuroprotective. We have completed an extensive systematic study with MRI, histopathology, proteomics and ELISA analyses designed to further define the severe protracted and damaging inflammation after SCI in a rat model. We have identified 3 distinct phases of SCI: acute (first 2 days), inflammatory (starting day 3) and resolution (>3 months) in 16 weeks follow up. Actively phagocytizing, CD68+/CD163- macrophages infiltrate myelin-rich necrotic areas converting them into cavities of injury (COI) when deep in the spinal cord. Alternatively, superficial SCI areas are infiltrated by granulomatous tissue, or arachnoiditis where glial cells are obliterated. In the COI, CD68+/CD163- macrophage numbers reach a maximum in the first 4 weeks and then decline. Myelin phagocytosis is present at 16 weeks indicating ongoing inflammatory damage. The COI and arachnoiditis are defined by a wall of progressively hypertrophied astrocytes. MR imaging indicates persistent spinal cord edema that is linked to the severity of inflammation. Microhemorrhages in the spinal cord around the lesion are eliminated, presumably by reactive astrocytes within the first week post-injury. Acutely increased levels of TNF-alpha, IL-1beta, IFN-gamma and other pro-inflammatory cytokines, chemokines and proteases decrease and anti-inflammatory cytokines increase in later phases. In this study we elucidated a number of fundamental mechanisms in pathogenesis of SCI and have demonstrated a close association between progressive astrogliosis and reduction in the severity of inflammation.
| S-EPMC7081990 | biostudies-literature
Project description:BackgroundWhile spinal cord injury (SCI) caregiving can be a rewarding experience, caregivers often experience reduced mental and physical health.ObjectiveThis article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI.MethodsA mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control. The study is recruiting for 48 months and incorporating quantitative outcome measures.ResultsThis study was funded by the Craig H. Neilsen Foundation in April 2017. It was approved by the institutional review boards at Virginia Commonwealth University and the Hunter Holmes McGuire Veterans Affairs Medical Center that same year. Participant recruitment and data collection began in 2018.ConclusionsThis study is implementing and testing an SCI caregiver intervention unlike any created before, targeting a critical time period that, until now, other SCI caregiver interventions have overlooked. Research personnel intend to disseminate the intervention and study findings through the publication of manuscripts and presentations at conferences. If the current study shows improvements in caregiver or patient well-being, the TAP for SCI caregivers could become part of the standard of care for acute SCI.Trial registrationClinicalTrials.gov NCT03244098; https://www.clinicaltrials.gov/ct2/show/NCT03244098.International registered report identifier (irrid)DERR1-10.2196/28256.
| S-EPMC8086783 | biostudies-literature
Project description:BackgroundUrinary retention is a common complication of spinal cord injury (SCI), which can seriously affect the quality of life of patients. Function magnetic stimulation (FMS) has been widely used in the recovery of neurological function in various diseases, but its application in urinary retention after SCI remains unclear. Therefore, we would like to conduct a pilot randomized controlled trial (RCT) to observe the feasible effect of FMS on urinary retention after SCI, to explore its mechanism of action.Method/designThis is a single-center pilot RCT, which 60 patients with urinary retention after SCI will be selected, numbered in chronological order of hospitalization, and randomly divided into 4 groups using the random number table method, Groups A (control group), Group B, Group C, and Group D; Each group will receive the same conventional rehabilitation treatment. The whole intervention period 2 weeks and will be evaluated before and after treatment to collect data on residual bladder volume, functional near-infrared spectroscopy (fNIRS), changes in voiding condition, changes in surface electromyography (SEMG) values of pelvic floor muscle and quality of life scores (QoL).Study hypothesisWe hypothesized that FMS for the treatment of urinary retention after SCI would have a significant clinical feasible effect;and that peripheral combined with central FMS would be more effective than single-site FMS for the treatment of urinary retention after SCI.Objective(1) To illustrate the clinical effectiveness of FMS in the treatment of urinary retention after SCI and to provide a new treatment modality for the patients; (2) Comparison of the differences in the efficacy of central and peripheral single FMS and combined central and peripheral FMS in the treatment of urinary retention after SCI; (3) To explore the central control mechanisms of bladder function recovery after SCI in conjunction with changes in fNIRS.Trial registrationThis study has been ethically approved by the Scientific and Ethics Committee of the First Affiliated Hospital of Gannan Medical university with approval number (LLSC-2022112401). It has been registered with the China Clinical Trials Registry with the registration number: ChiCTR2200067143.
| S-EPMC10797019 | biostudies-literature
Project description:Posttraumatic stress disorder (PTSD) is related to an increased risk of smoking cessation failure. In fact, the quit rate in smokers with PTSD (23.2%) is one of the lowest of all mental disorders. Features of PTSD that contribute to smokers' progression to nicotine dependence and cessation relapse include negative affect, fear, increased arousal, irritability, anger, distress intolerance, and anxiety sensitivity. Anxiety sensitivity is higher in people with PTSD than in any other anxiety disorder except for panic disorder. High anxiety sensitivity is uniquely associated with greater odds of lapse and relapse during quit attempts. Distress intolerance, a perceived or behavioral tendency to not tolerate distress, is related to both the maintenance of PTSD and problems in quitting smoking. Prolonged exposure (PE) and interoceptive exposure (IE) reduce PTSD symptoms, distress intolerance, and anxiety sensitivity. Thus, they emerge as promising candidates to augment standard smoking cessation interventions for individuals with PTSD. The present study tests a 12-session specialized treatment for smokers with PTSD. This Integrated PTSD and Smoking Treatment (IPST) combines cognitive-behavioral therapy and nicotine replacement treatment for smoking cessation (standard care; SC) with PE to target PTSD symptoms and IE to reduce anxiety sensitivity and distress intolerance. Adult smokers (N=80) with PTSD will be randomly assigned to either: (1) IPST or (2) SC. Primary outcomes are assessed at weeks 0, 6, 8, 10, 14, 16, 22, and 30.
| S-EPMC5695545 | biostudies-literature
Project description:ObjectiveSelective serotonin reuptake inhibitors (SSRIs) are often recommended in combination with established cognitive-behavioral therapies (CBTs) for posttraumatic stress disorder (PTSD), but combined initial treatment of PTSD has not been studied under controlled conditions. There are also few studies of either SSRIs or CBT in treating PTSD related to terrorism. The authors compared prolonged exposure therapy (a CBT) plus paroxetine (an SSRI) with prolonged exposure plus placebo in the treatment of terrorism-related PTSD.MethodAdult survivors of the World Trade Center attack of September 11, 2001, with PTSD were randomly assigned to 10 weeks of treatment with prolonged exposure (10 sessions) plus paroxetine (N=19) or prolonged exposure plus placebo (N=18). After week 10, patients discontinued prolonged exposure and were offered 12 additional weeks of continued randomized treatment.ResultsPatients treated with prolonged exposure plus paroxetine experienced significantly greater improvement in PTSD symptoms (incidence rate ratio=0.50, 95% CI=0.30-0.85) and remission status (odds ratio=12.6, 95% CI=1.23-129) during 10 weeks of combined treatment than patients treated with prolonged exposure plus placebo. Response rate and quality of life were also significantly more improved with combined treatment. The subset of patients who continued randomized treatment for 12 additional weeks showed no group differences.ConclusionsInitial treatment with paroxetine plus prolonged exposure was more efficacious than prolonged exposure plus placebo for PTSD related to the World Trade Center attack. Combined treatment medication and prolonged exposure therapy deserves further study in larger samples with diverse forms of PTSD and over longer follow-up periods.
| S-EPMC3606709 | biostudies-literature