Effectiveness of mindfulness-based cognitive therapy follow-up programs for pharmacotherapy refractory anxiety disorders: a study protocol for a randomized controlled feasibility trial (Preprint)

2021 ◽  
Author(s):  
Mitsuhiro Sado ◽  
Akira Ninomiya ◽  
Maki Nagaoka ◽  
Akihiro Koreki ◽  
Naho Goto ◽  
...  

BACKGROUND Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported as effective post treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. OBJECTIVE This study aims to examine the feasibility, acceptability, and effectiveness of the follow-up program by conducting a feasibility randomized controlled trial (RCT) to compare the augmented MBCT with follow-up and that without follow-up in preparation for a definitive RCT. METHODS We conducted an eight-week RCT with a ten-month follow-up. Patients aged 20–65 years who met the DSM-IV criteria for panic disorder, agoraphobia, or social anxiety disorder, not remitted with the usual treatment for at least four weeks were included in the study and randomly allocated to the augmented MBCT with follow-up sessions or the augmented MBCT without the follow-up sessions. For this feasibility RCT, the primary outcomes were 1) study inclusion rate, 2) dropout rate, 3) attendance rate, and 4) mean and standard deviation of the several clinical measures at 8 weeks and 5, 8, and 12 months. RESULTS We started recruiting participants in January 2020. The study is ongoing, and data collection will be completed by May 2022. CONCLUSIONS This study is novel in terms of the design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: 1) mixed participants in terms of delivery mode of the intervention, and 2) lack of a pharmacotherapy-alone arm. For its novelty and significance, this study will bring fruitful knowledge to future definitive RCTs. CLINICALTRIAL UMIN Clinical Trials Registry: UMIN000038626. Registered November 19, 2019.

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  

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.


Author(s):  
Angela A T Schuurmans ◽  
Karin S Nijhof ◽  
Ron Scholte ◽  
Arne Popma ◽  
Roy Otten

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


2021 ◽  
Author(s):  
Lauren Ng ◽  
Eyerusalem Getachew Serba ◽  
Benyam W. Dubale ◽  
Abebaw Fekadu ◽  
Charlotte Hanlon

Abstract BackgroundIn this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization’s guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings. MethodsSpecifically, this study includes a non-randomized pre-pilot (n=5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n=40) to assess trial procedures, acceptability and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, one-month follow-up, and three-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal. DiscussionFindings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings. Trial RegistrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1.


Pain Medicine ◽  
2019 ◽  
Vol 20 (11) ◽  
pp. 2134-2148 ◽  
Author(s):  
Melissa A Day ◽  
L Charles Ward ◽  
Dawn M Ehde ◽  
Beverly E Thorn ◽  
John Burns ◽  
...  

AbstractObjectiveThis pilot trial compared the feasibility, tolerability, acceptability, and effects of group-delivered mindfulness meditation (MM), cognitive therapy (CT), and mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP).SettingUniversity of Queensland Psychology Clinic.SubjectsParticipants were N = 69 (intent-to-treat [ITT] sample) adults with CLBP.DesignA pilot, assessor-blinded randomized controlled trial.MethodsParticipants were randomized to treatments. The primary outcome was pain interference; secondary outcomes were pain intensity, physical function, depression, and opioid medication use. The primary study end point was post-treatment; maintenance of gains was evaluated at three- and six-month follow-up.ResultsRatings of acceptability, and ratios of dropout and attendance showed that MBCT was acceptable, feasible, and well tolerated, with similar results found across conditions. For the ITT sample, large improvements in post-treatment scores for pain interference, pain intensity, physical function, and depression were found (P < 0.001), with no significant between-group differences. Analysis of the follow-up data (N = 43), however, revealed that MBCT participants improved significantly more than MM participants on pain interference, physical function, and depression. The CT group improved more than MM in physical function. The MBCT and CT groups did not differ significantly on any measures.ConclusionsThis is the first study to examine MBCT for CLBP management. The findings show that MBCT is a feasible, tolerable, acceptable, and potentially efficacious treatment option for CLBP. Further, MBCT, and possibly CT, could have sustained benefits that exceed MM on some important CLBP outcomes. A future definitive randomized controlled trial is needed to evaluate these treatments and their differences.


2019 ◽  
Vol 88 (4) ◽  
pp. 244-246 ◽  
Author(s):  
Naoki Yoshinaga ◽  
Kazumi Kubota ◽  
Kensuke Yoshimura ◽  
Rieko Takanashi ◽  
Yasushi Ishida ◽  
...  

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh

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.


2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.


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