Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up

2020 ◽  
Vol 273 ◽  
pp. 265-273
Author(s):  
Rhoda Schuling ◽  
Marloes J. Huijbers ◽  
Hiske van Ravesteijn ◽  
Rogier Donders ◽  
Linda Cillessen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Recurrent Depression ◽  
Treatment As Usual ◽  
Randomized Controlled

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.

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

A Culturally Adapted Cognitive Behavioral Therapy Group: A Randomized Controlled Trial

2021 ◽  
pp. 104973152110636
Author(s):  
Daniel K. W. Young ◽  
Petrus NG Yat-nam
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Medium Effect ◽  
Chinese People ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Allocation Process ◽  
Culturally Adapted

Objective This study aimed to evaluate a culturally adapted cognitive behavior therapy (CBT) group for Chinese people with depression that aimed to alter participants’ negative beliefs of themselves, which were influenced by traditional Chinese cultural values. Method In this randomized controlled trial, 43 participants diagnosed with depression were randomly allocated to a 10-session culturally adapted CBT group or treatment as usual (TAU). A research assistant, who was blinded to the group allocation process, used the Chinese Beck Depression Inventory-II to assess participants’ depressive symptoms during the pre-treatment and post-treatment periods. Results The results of the mixed linear model for repeated measures showed that the CBT group had significantly greater improvement in depressive symptoms than treatment as usual, with a medium effect size. Conclusion This study supports the efficacy and effectiveness of the culturally adapted CBT group in facilitating clinically significant improvement in Chinese people with depression.

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.

Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes
Keyword(s):  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Post Traumatic Stress ◽  
Treatment As Usual ◽  
Seeking Safety ◽  
Randomized Controlled

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.

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 Outcomes of a Cluster Randomized Controlled Trial of the SoMe Social Media Literacy Program for Improving Body Image-Related Outcomes in Adolescent Boys and Girls

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3825
Author(s):  
Chloe S. Gordon ◽  
Hannah K. Jarman ◽  
Rachel F. Rodgers ◽  
Siân A. McLean ◽  
Amy Slater ◽  
...  
Keyword(s):  
Social Media ◽  
Body Image ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Media Literacy ◽  
Controlled Trial ◽  
Intervention Effects ◽  
Randomized Controlled ◽  
Cluster Randomized

Although the negative effect of social media use among youth on body image and eating concerns has been established, few classroom-based resources that can decrease these effects through targeting social media literacy skills have been developed. This study aimed to test the efficacy of SoMe, a social media literacy body image, dieting, and wellbeing program for adolescents, through a cluster randomized controlled trial. Participants (n = 892; Mage = 12.77, SD = 0.74; range 11–15; 49.5% male) were randomized by school (n = 8) to receive either weekly SoMe (n = 483) or control sessions (lessons as usual; n = 409) over 4 weeks in their classroom. Participants completed surveys at four timepoints (baseline, 1-week post-intervention, and 6- and 12-month follow-up) assessing body dissatisfaction, dietary restraint, strategies to increase muscles (primary outcomes), self-esteem and depressive symptoms (secondary outcomes), and internalization of appearance ideals and appearance comparison (exploratory outcomes). Modest positive intervention effects were found in dietary restraint and depressive symptoms at 6-month follow-up in girls but few positive effects emerged for boys. The findings provide only preliminary support for a social media literacy intervention, but suggest the usefulness of both identifying those who benefit most from a universally delivered intervention and the need to refine the intervention to maximize intervention effects.

scholarly journals A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alicia Salamanca-Sanabria ◽  
Derek Richards ◽  
Ladislav Timulak ◽  
Sarah Connell ◽  
Monica Mojica Perilla ◽  
...  
Keyword(s):  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Treatment Group ◽  
Controlled Trial ◽  
Control Group ◽  
Large Effect Size ◽  
Randomized Controlled ◽  
Culturally Adapted

BACKGROUND Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (<i>t</i> <sub>197.54</sub>=−5.189; <i>P</i>&lt;.001) for the treatment group, and these effects were maintained at the 3-month follow-up (<i>t</i> <sub>39.62</sub>=4.668; <i>P</i>&lt;.001). Within-group results for the treatment group yielded a large effect size post treatment (<i>d</i>=1.44; <i>P</i>&lt;.001), and this was maintained at the 3-month follow-up (<i>d</i>=1.81; <i>P</i>&lt;.001). In addition, the LMM showed significant differences between the groups (<i>t</i> <sub>197.54</sub>=−5.189; <i>P</i>&lt;.001). The results showed a large effect size between the groups (<i>d</i>=0.91; <i>P</i>&lt;.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X<sup>2</sup><sub>2</sub>=10.5; <i>P</i>=.001). CONCLUSIONS This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. CLINICALTRIAL ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215

Sign in / Sign up

Export Citation Format

Share Document