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An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Posttraumatic stress disorder (PTSD) rarely remits over time, and if left untreated, leads to significant distress, functional impairment, and increased health care costs. Fortunately, effective evidence-based treatments (EBTs) for PTSD, such as Prolonged Exposure (PE), exist. Despite their availability and efficacy, a significant number of individuals with PTSD do not initiate treatment when offered or dropout prematurely. One proposed theory suggests that the emotional-numbing symptoms of PTSD (e.g., blunted affect, apathy) can serve as a barrier to engaging in, and successfully completing, treatment; and the broad human-animal interaction (HAI) literature available suggests that HAI can potentially reduce emotional numbing related to PTSD. Accordingly, this manuscript describes an ongoing, federally funded, randomized controlled trial testing the efficacy of RESCUE, an HAI intervention, as a viable adjunctive treatment component for PE. METHODS/DESIGN:The study will include 70 veterans with PTSD treated at a Southeastern Veterans Affairs Medical Center (VAMC). All participants in the trial receive up to 12 sessions of PE. Participants are randomly assigned 1:1 to (1) volunteer at a local animal shelter or (2) volunteer at a community agency of their choice as part of their in-vivo exposure exercises for PE. Outcomes will be examined via standard clinical interviews, self-report questionnaires, and thematic interviews. DISCUSSION:It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition. If successful, RESCUE, could be easily incorporated into standard PE and broadly disseminated. TRIAL REGISTRATION:ClinicalTrials.gov. ID: NCT03504722. Retrospectively registered on 2 May 2017.

SUBMITTER: Grubaugh AL

PROVIDER: S-EPMC6935088 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

Grubaugh Anouk L AL Myers Ursula S US Keller Stephanie M SM Wangelin Bethany C BC Lozano Brian E BE Tuerk Peter W PW

Trials 20191227 1

<h4>Background</h4>Posttraumatic stress disorder (PTSD) rarely remits over time, and if left untreated, leads to significant distress, functional impairment, and increased health care costs. Fortunately, effective evidence-based treatments (EBTs) for PTSD, such as Prolonged Exposure (PE), exist. Despite their availability and efficacy, a significant number of individuals with PTSD do not initiate treatment when offered or dropout prematurely. One proposed theory suggests that the emotional-numbi ...[more]

PMID: 31881993

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Project description:ObjectiveScalable, efficiently delivered treatments are needed to address the needs of women Veterans with PTSD. This randomized clinical trial compared an online, coach-assisted cognitive behavioral intervention tailored for women Veterans with PTSD to phone monitoring only.MethodWomen Veterans who met diagnostic criteria for PTSD were randomized to an 8-week web-based intervention, called DElivery of Self TRaining and Education for Stressful Situations (DESTRESS)-Women Veterans version (WV), or to phone monitoring only (N = 102). DESTRESS-WV consisted of online sessions and 15-min weekly phone calls from a study coach. Phone monitoring included 15-min weekly phone calls from a study coach to offer general support. PTSD symptom severity (PTSD Symptom-Checklist-Version 5 [PCL-5]) was evaluated pre and posttreatment, and at 3 and 6 months posttreatment.ResultsMore participants completed phone monitoring than DESTRESS-WV (96% vs. 76%, p = 0.01), although treatment satisfaction was significantly greater in the DESTRESS-WV condition. We failed to confirm the superiority of DESTRESS-WV in intent-to-treat slope changes in PTSD symptom severity. Both treatments were associated with significant reductions in PTSD symptom severity over time. However, post hoc analyses of treatment completers and of those with baseline PCL ≥ 33 revealed that the DESTRESS-WV group had greater improvement in PTSD symptom severity relative to phone monitoring with significant differences at the 3-month follow-up assessment.ConclusionsBoth DESTRESS-WV and phone monitoring resulted in significant improvements in women Veterans' PTSD symptoms. DESTRESS-WV may be an appropriate care model for women Veterans who can engage in the demands of the treatment and have higher baseline symptoms. Future research should explore characteristics of and the methods of reliably identifying women Veterans who are most likely to benefit. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Project description:BackgroundChildren of parents with post-traumatic stress disorder (PTSD) are at increased risk of adverse psychological outcomes. An important risk mechanism is impaired parental functioning, including negative parenting behavior, perceived incompetence, and lack of social support. Several parenting interventions for trauma-exposed parents and parents with psychiatric disorders exist, but none have specifically targeted parents with PTSD. Our objective is to evaluate the effectiveness of a blended care preventive parenting intervention for parents with PTSD.MethodsThe intervention was adapted from an existing online intervention, KopOpOuders Self-Help. In co-creation with parents with PTSD and partners, the intervention was adapted into KopOpOuders-PTSD, by adding PTSD-specific content and three in-person-sessions with a mental health prevention professional. Effectiveness will be tested in a randomized controlled trial among N = 142 parents being treated for PTSD at Arkin Mental Health Care (control condition: treatment as usual, n = 71; intervention condition: treatment as usual + intervention, n = 71). Online questionnaires at pretest, posttest, and three-month follow-up and ecological momentary assessment at pretest and posttest will be used. Intervention effects on primary (parenting behavior) and secondary outcomes (perceived parenting competence, parental social support, parenting stress, child overall psychological problems and PTSD symptoms) will be analyzed using generalized linear mixed modeling. We will also analyze possible moderation effects of parental PTSD symptoms at pretest on primary and secondary outcomes.DiscussionThis study protocol describes the randomized controlled trial of KopOpOuders-PTSD, a blended care preventive parenting intervention for parents with PTSD. Findings can contribute to understanding of the effectiveness of parenting support in clinical practice for PTSD.Trial registrationThis protocol (Version 1) was registered on 11-02-2022 at ClinicalTrials.gov under identification number NCT05237999.

Project description:BackgroundVeterans with psychiatric disorders want additional career development services to support their recovery and pursuit of meaningful employment. However, no career counseling programs have been designed for this specific population. We developed the Purposeful Pathways intervention to fill this need.ObjectiveThis study protocol aims to (1) evaluate the feasibility and acceptability of the Purposeful Pathways intervention for veterans living with psychiatric disorders and (2) explore preliminary clinical outcome data.MethodsA total of 50 veterans who are participating in transitional work vocational rehabilitation services at a Veterans Affairs hospital will be randomized to either treatment as usual or the augmented treatment condition (treatment as usual plus Purposeful Pathways). Feasibility will be assessed via recruitment rates, clinician fidelity to treatment, retention rates, and acceptability of randomization procedures. Acceptability will be assessed via client satisfaction at treatment termination using quantitative and qualitative data collection. Preliminary clinical and vocational outcomes will be assessed at baseline, 6 weeks, 12 weeks (treatment termination), and a 3-month follow-up via quantitative measures assessing vocational functioning, vocational process, and mental and physical functioning.ResultsThis pilot randomized controlled trial is beginning recruitment in June 2023 and is expected to continue through November 2025. Data collection is expected to be completed by February 2026, with full data analysis completed by March 2026.ConclusionsFindings from this study will provide information on the feasibility and acceptability of the Purposeful Pathways intervention, as well as secondary outcomes related to vocational functioning, vocational process, and mental and physical functioning.Trial registrationClinicalTrials.gov NCT04698967; https://clinicaltrials.gov/ct2/show/NCT04698967.International registered report identifier (irrid)PRR1-10.2196/47986.

Project description:BackgroundVarious hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trials conducted with hospital inpatients vary widely in methodological quality. While the majority of these studies indicate limited to no effects of BI in this population, none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null: assessment reactivity (AR).Methods/designThis is a three-arm, single-site, randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder. Participants are randomized to one of three study conditions. Study Arm 1 receives a three-part alcohol BI. Study Arm 2 receives attention control. To account for potential AR, Study Arm 3 receives AC with limited assessment. Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge. Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use. To assess differences in primary outcomes across the three arms, we will use mixed-effects regression models that account for a patient's repeated measures over the timepoints and clustering within medical units. Intervention implementation will be assessed by: a) review of intervention audio recordings to characterize barriers to intervention fidelity; and b) feasibility of participant recruitment, enrollment, and follow-up.DiscussionThe results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures.Trial registrationNCT01602172.

Project description:BackgroundDue to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the feasibility and effect of this type of intervention needs testing.MethodsThe study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The primary feasibility outcome is the proportion of eligible patients that participate in the study until the end assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, and recovery.DiscussionThis study may help increase our knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector.Trial registrationThe trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.

Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

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An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

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An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

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