scholarly journals Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Angela A T Schuurmans ◽  
Karin S Nijhof ◽  
Ron Scholte ◽  
Arne Popma ◽  
Roy Otten
Keyword(s):  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Self Report ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Posttraumatic Symptoms ◽  
Secondary Outcomes ◽  
Anxiety Depression

BACKGROUND Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. OBJECTIVE This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. METHODS This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. RESULTS The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. CONCLUSIONS Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. CLINICALTRIAL Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19881

scholarly journals Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial

10.2196/19881 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e19881 ◽  
Author(s):  
Angela A T Schuurmans ◽  
Karin S Nijhof ◽  
Ron Scholte ◽  
Arne Popma ◽  
Roy Otten
Keyword(s):  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Self Report ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Posttraumatic Symptoms ◽  
Secondary Outcomes ◽  
Anxiety Depression

Background Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID) DERR1-10.2196/19881

scholarly journals The effectiveness of game-based meditation therapy for traumatized adolescents in residential care: a randomized controlled trial (PREPRINT)

2021 ◽  
Author(s):  
Angela Schuurmans ◽  
Karin Nijhof ◽  
Arne Popma ◽  
Ron Scholte ◽  
Roy Otten
Keyword(s):  
Posttraumatic Stress ◽  
Residential Care ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Treatment As Usual ◽  
Posttraumatic Symptoms ◽  
Significant Difference ◽  
Evidence Based Treatments ◽  
Anxiety Depression

Aim: Many adolescents in residential care have experienced traumatic events and suffer from posttraumatic stress. This study examined the effectiveness of Muse, a game-based meditation intervention, as an addition to treatment as usual (TAU) for traumatized adolescents in residential care.Methods: Seventy-seven traumatized adolescents (10 – 18 years old) received either Muse and TAU (n = 37) or treatment as usual alone (n = 40). TAU consisted of evidence-based treatments that did not specifically target posttraumatic symptoms. Outcomes were measured at T1, T2, and two-months follow-up (FU). Primary outcomes were posttraumatic symptoms (self-report and mentor-report) and stress (self-report) at T2. Secondary outcomes included anxiety, depression, and aggression at T2, and all outcomes at follow-up.Results: The Muse group showed significantly greater improvements than the control group at T2 regarding self-reported posttraumatic symptoms, stress, anxiety, depression, and aggression. Mentor reports showed marginally significant decreases in posttraumatic stress at T2. There were no differences between the groups at FU, except for a marginally significant difference in self-reported posttraumatic symptoms, where the Muse participants showed larger decreases.Conclusions: Game-based meditation therapy is a promising intervention that is more effective than treatment as usual alone. Implications of these findings for the role of game-based meditation interventions for traumatized adolescents in residential care are discussed.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Valentin Garyga ◽  
Florian Pochelu ◽  
Béatrice Thivichon-Prince ◽  
Walid Aouini ◽  
Julie Santamaria ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Motivational Interviewing ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Personalized Video

Abstract Background Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Several clinical frameworks have been developed to foster behavior change, such as motivational interviewing. However, two obstacles can be identified. First, patients tend to forget the advice they were given during the consultation. Second, it is hard to maintain motivation in the long term, thus leading to relapse. An innovative eHealth solution was designed with the aim to tackle both obstacles and supplement the current clinical standard of care. The primary objective is to compare the full mouth plaque scores of study groups (eHealth plus standard of care versus standard of care only) at 8 weeks of follow up. The main secondary objective is to compare the full mouth bleeding score at 8 weeks of follow up. Methods/design The “GoPerio” study is a multicenter, randomized, controlled trial assessing the impact of a novel eHealth concept for oral hygiene motivation (personalized video of oral hygiene routine available for the patient via a cloud server plus interactive text messages) in addition to the current standard of care (motivational interviewing plus tooth scaling and polishing). The minimum sample size required is 86 patients. Participants will be randomized (allocation ratio 1:1): test group (eHealth plus standard of care) versus control group (standard of care only). The primary outcome is oral hygiene as measured by the full mouth (six sites per tooth) plaque control record (PCR) index. The main secondary outcome is gingival inflammation as measured by the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes are evaluated by blinded and calibrated examiners at 8 weeks of follow up. The other secondary outcomes are patient satisfaction and patient behavior change and motivation. Discussion The study will investigate the value of an innovative eHealth approach to strengthen patient motivation for oral hygiene. If proven effective, such an approach would supplement the current clinical standard of care, resulting in improved clinical outcomes with negligible impact on productivity in a dental practice. Trial registration ClinicalTrials.gov, NCT03109808. Registered on 12 April 2017. Sponsor: Hospices Civils de Lyon. BP 2251, 3 quai des Célestins, 69,229 Lyon cedex 02. Protocol version: 1.0 as of 21 September 2016.

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

scholarly journals Results of the first randomized controlled trial of integrated cognitive-behavioral therapy for eating disorders and posttraumatic stress disorder

2021 ◽  
pp. 1-10
Author(s):  
Kathryn Trottier ◽  
Candice M. Monson ◽  
Stephen A. Wonderlich ◽  
Ross D. Crosby
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Eating Disorders ◽  
Randomized Controlled Trial ◽  
Posttraumatic Stress ◽  
Stress Disorder ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Ptsd Symptoms ◽  
Randomized Controlled

Abstract Background Eating disorders (EDs) and posttraumatic stress disorder (PTSD) frequently co-occur and can share a functional relationship. The primary aim of this initial randomized controlled trial was to determine whether integrated cognitive-behavioral therapy (CBT) for co-occurring ED-PTSD was superior to standard CBT for ED in improving PTSD symptoms. Intervention safety and desirability, as well as the relative efficacy of the treatments in improving anxiety, depression, and ED symptomatology, were also examined. Methods Following a course of intensive ED treatment, individuals with ED-PTSD were recruited to participate and randomized to integrated CBT for ED-PTSD or standard CBT for ED. The sample consisted of 42 individuals with a range of ED diagnoses. Outcomes were assessed at end-of-treatment, 3-, and 6-month follow-up using interview and self-report measures. Results Mixed models revealed significant interactions of time and therapy condition on clinician-rated and self-reported PTSD symptom severity favoring Integrated CBT for ED-PTSD. Both treatments were associated with statistically significant improvements in PTSD, anxiety, and depression. Improvements were maintained at 3- and 6-month follow-up. There was good safety with both interventions, and satisfaction with both treatments was high. However, there was a stronger preference for integrated treatment. Conclusions Integrating CBTs for PTSD and ED following intensive ED treatment is safe, desirable, and efficacious for improving PTSD symptoms. Future studies with larger sample sizes are needed to determine whether Integrated CBT for ED-PTSD provides benefits over standard CBT for ED with respect to ED outcomes.

Comparison of Brief Videos and Articles to Promote Coping Skills Among Student-Athletes

2020 ◽  
pp. 1-17
Author(s):  
Tyler L. Malone ◽  
Adam Kern ◽  
Emily Klueh ◽  
Daniel Eisenberg
Keyword(s):  
Randomized Controlled Trial ◽  
College Student ◽  
Student Athletes ◽  
Coping Skills ◽  
Controlled Trial ◽  
Self Report ◽  
Deep Breathing ◽  
Randomized Controlled ◽  
College Student Athletes

This study sought to determine the efficacy of particular strategies for delivering information about coping skills for stress to college student-athletes. This study analyzed 166 undergraduate varsity student-athletes. Among these participants, 60.8% were female (n = 101). The authors used a randomized controlled trial to compare video-based and text-based interventions designed to deliver coping skills information. Five weeks after the intervention, the participants completed a follow-up survey containing simple self-report questions regarding the memorability, use, and helpfulness of the coping skills information. In general, both strategies led to the use of coping skills by a sizeable proportion of the sample. The participants in the video-based deep breathing intervention were more than twice as likely to use coping skills compared with participants in the text-based intervention (risk ratio = 2.20, 95% confidence interval [1.02, 4.71], p = .03). Overall, the results suggest that both video- and text-based interventions have the potential to promote coping skills.

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