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Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial.

ABSTRACT: The National Spinal Cord Injury Statistical Center estimates 294,000 people in the US live with a spinal cord injury (SCI), with approximately 17,810 new cases each year. Although the physical outcomes associated with SCI have been widely studied, the psychological consequences of sustaining a SCI remain largely unexplored. Scant research has focused on posttraumatic stress disorder (PTSD) in this population, despite prevalence estimates suggesting that up to 60% of individuals with SCI experience PTSD post-injury, compared to only 7% of the general US population. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. However, no trauma focused exposure-based therapy for PTSD (e.g. PE) has not yet been tested in a SCI population. Thus, we aim to conduct the first test of an evidence-based intervention for PTSD among patients with SCI. Adults with SCI and PTSD (N = 60) will be randomly assigned to either: (1) 12-sessions of PE (2-3 sessions per week) or (2) a treatment as usual (TAU) control group who will receive the standard inpatient rehabilitation care for SCI patients. Primary outcomes will be assessed at 0, 6, 10, and 32 weeks.

SUBMITTER: Powers MB

PROVIDER: S-EPMC8113811 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial.

Powers Mark B MB Pogue Jamie R JR Curcio Nicholas E NE Patel Sarita S Wierzchowski Andrea A Thomas Estrella V EV Warren Ann Marie AM Adams Maris M Turner Emma E Carl Emily E Froehlich-Grobe Katherine K Sikka Seema S Foreman Michael M Leonard Kiara K Douglas Megan M Bennett Monica M Driver Simon S

Contemporary clinical trials communications 20210331

The National Spinal Cord Injury Statistical Center estimates 294,000 people in the US live with a spinal cord injury (SCI), with approximately 17,810 new cases each year. Although the physical outcomes associated with SCI have been widely studied, the psychological consequences of sustaining a SCI remain largely unexplored. Scant research has focused on posttraumatic stress disorder (PTSD) in this population, despite prevalence estimates suggesting that up to 60% of individuals with SCI experien ...[more]

PMID: 34013091

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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.

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.

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.

Project description:BackgroundGeographical, financial and travel-related barriers may impact access to necessary health care for people in need of long-term follow-up.ObjectiveThe goal of the research was to perform a nonblinded, randomized, controlled trial on health-related quality of life (HRQoL), healing, interaction, and satisfaction of patients with spinal cord injury (SCI) and PI receiving multidisciplinary videoconference consultations from a wound clinic to the participant's home versus regular outpatient care. The multidisciplinary team consisted of a medical doctor, a wound nurse, and an occupational therapist. In both groups, district nurses attended the consultations at the participant's home.MethodsA total of 56 participants, 28 in each group, were randomized to a videoconference group (VCG) or a regular care group (RCG). Validated questionnaires were used to measure and compare the follow-up effect on HRQoL. Percentage reduction of wound volume was measured at end of the follow-up. A Likert scale was used to measure the satisfaction of the patients and district nurses regarding the interaction between different modalities of care in the 2 groups.ResultsThe HRQoL did not show significant differences between the 2 groups (P values ranging from .09 to .88) or the rate of PI healing, experienced interaction, and satisfaction in the groups. A total of 67% (37/55) of all PIs healed, 64% (18/28) in the VCG and 70% (19/27) in the RCG. Mean reduction in ulcer volume was 79% in the VCG and 85% in the RCG (P=.32). A Kaplan-Meier plot with a logrank test regarding time to healing did not show any significant difference between the 2 groups.ConclusionsVideoconference-based care seems to be a safe and efficient way to manage PIs in terms of HRQoL, healing, interaction, and satisfaction compared to conventional care for people with SCI. This should be considered when planning for future care. SCI has a huge impact on the individual, the family, and the health care system. There is an urgent need to improve systems of care so that individuals who live far from specialists and require long-term follow-up for conditions such as PI can get optimal treatment.Trial registrationClinicalTrials.gov NCT02800915; https://clinicaltrials.gov/ct2/show/NCT02800915 and Current Research Information System in Norway (CRISTIN) 545284; https://app.cristin.no/projects/show.jsf?id=545284.

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Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial.

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Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial.

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