Dataset Information

Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD.

ABSTRACT: Posttraumatic stress disorder (PTSD) is a serious condition, with certain occupations at increased risk due to greater trauma exposure. These same individuals face multiple barriers to care. This study aimed to investigate the feasibility of conducting a research trial with exposure therapy delivered via videoconferencing. Eleven adults working in occupations at risk with PTSD enrolled and seven completed 12 to 15 sessions. Individuals were randomized to receive the cognitive enhancer D-cycloserine or placebo, and participants provided saliva samples for genetic analysis. Treatment completers demonstrated decreases in PTSD and depressive symptomatology (measured by CAPS [p < 0.001, d = 2.79] and BDI-II [p = 0.004, d = 0.92]). Participants reported high therapeutic alliance, treatment satisfaction, and telehealth satisfaction. There were no significant technical, medication, or safety issues, and no clinical emergencies. The results suggest that it may be feasible to conduct clinical research using telehealth for PTSD and to use telehealth to increase access to care.

SUBMITTER: Olden M

PROVIDER: S-EPMC5253124 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD.

Olden Megan M Wyka Katarzyna K Cukor Judith J Peskin Melissa M Altemus Margaret M Lee Francis S FS Finkelstein-Fox Lucy L Rabinowitz Terry T Difede JoAnn J

The Journal of nervous and mental disease 20170201 2

Posttraumatic stress disorder (PTSD) is a serious condition, with certain occupations at increased risk due to greater trauma exposure. These same individuals face multiple barriers to care. This study aimed to investigate the feasibility of conducting a research trial with exposure therapy delivered via videoconferencing. Eleven adults working in occupations at risk with PTSD enrolled and seven completed 12 to 15 sessions. Individuals were randomized to receive the cognitive enhancer D-cycloser ...[more]

PMID: 27441461

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Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Project description:Background: Concussion is common, and up to 30% of youth develop persistent symptoms. Preliminary data suggests treatment with rehabilitative exercise is beneficial, but most programs require frequent in-person visits, which is challenging for youth in rural areas, and has been made more difficult for all youth during the COVID-19 pandemic. We have adapted an exercise intervention to be delivered via telehealth using Zoom and personal fitness devices, which could ensure access to this type of treatment. Objective: The goal of this study was to assess feasibility and acceptability of a telehealth delivered exercise intervention for concussion, the Mobile Subthreshold Exercise Program (MSTEP), and collect pilot data regarding efficacy. Materials and Methods: All youth received the 6-week MSTEP intervention which included wearing a Fitbit and setting exercise heartrate and duration goals weekly over Zoom with the research assistant. Youth completed standardized measures of concussive symptoms (Health Behavior Inventory, HBI), fear-avoidance (Fear of Pain Questionnaire, FOPQ) and health-related quality of life (Pediatric Quality of life Assessment, PedsQL), as well as a structured qualitative exit interview. We examined change in measures over time using mixed effects modeling, controlling for age, sex, prior concussion and duration of symptoms. We coded qualitative interviews using Thematic analysis. Results: We recruited 19 subjects, 79% female with average age 14.3 (SD 2.2) and mean duration of symptoms 75.6 days (SD 33.7). Participants wore the Fitbit on 80% of days, and completed 94% of surveys and 96% of Zoom calls. Concussive symptoms (HBI) decreased significantly over the 6 week intervention (-10.6, 95%CI: -16.0 to -5.1) as did fear-avoidance (-21.6, 95%CI: -29.8 to -13.5). PedsQL improved significantly during the same time period (+15.1, 95%CI: 8.6-21.6). Approximately three-quarters (76%) of youth rated their care as "excellent." Participants appreciated the structure of the guided exercise program and the support of the RA. They also enjoyed being able to track their progress with the Fitbit. Conclusion: This study provides evidence for the feasibility and acceptability of a telehealth delivered rehabilitative exercise intervention for youth with concussion. Further research utilizing a randomized controlled trial is needed to assess efficacy. Clinical Trial Registration: https://clinicaltrials.gov, identifier: NCT03691363. https://clinicaltrials.gov/ct2/show/NCT03691363.

Dataset Information

Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD.

Publications

Pilot Study of a Telehealth-Delivered Medication-Augmented Exposure Therapy Protocol for PTSD.

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