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Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Depression that occurs during the perinatal period has substantial costs for both the mother and her baby. Since in-person care often falls short of meeting the global need of perinatal women, Internet interventions may function as an alternate to help women who currently lack adequate access to face-to-face psychological resources. However, at present there are insufficient empirically supported Internet-based resources for perinatal women. OBJECTIVE:The aim of this study is to compare the relative efficacy of Internet-based cognitive behavioral therapy (CBT) to a novel Internet-based compassionate mind training approach (CMT) across measures of affect, self-reassurance, self-criticizing, self-attacking, self-compassion, depression, and anxiety. While CBT has been tested and has some support as an Internet tool for perinatal women, this is the first trial to look at CMT for perinatal women over the Internet. METHODS:Participants were recruited through Amazon Mechanical Turk (MTurk) and professional networks. Following completion of demographic items, participants were randomly assigned to either the CBT or CMT condition. Each condition consisted of 45-minute interactive didactic and follow-up exercises to be completed over the course of two weeks. RESULTS:Post course data was gathered at two weeks. A 2x2 repeated measures analysis of variance will be conducted to analyze differences between conditions at post course. CONCLUSIONS:The implications of the trial will be discussed as well as the strengths and limitations of MTurk as a tool for recruitment. We will also briefly introduce the future directions along this same line of research. TRIAL REGISTRATION:ClinicalTrials.gov NCT02469324; https://clinicaltrials.gov/ct2/show/NCT02469324 (Archived by WebCite at http://www.webcitation.org/6fkSG3yuW).

SUBMITTER: Kelman AR

PROVIDER: S-EPMC4851724 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled Trial.

Kelman Alex R AR Stanley Meagan L ML Barrera Alinne Z AZ Cree Michelle M Heineberg Yotam Y Gilbert Paul P

JMIR research protocols 20160415 2

<h4>Background</h4>Depression that occurs during the perinatal period has substantial costs for both the mother and her baby. Since in-person care often falls short of meeting the global need of perinatal women, Internet interventions may function as an alternate to help women who currently lack adequate access to face-to-face psychological resources. However, at present there are insufficient empirically supported Internet-based resources for perinatal women.<h4>Objective</h4>The aim of this st ...[more]

PMID: 27084301

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Project description:BackgroundAlthough many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care.ObjectiveThis randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth.MethodsThis nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale.ResultsWe included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=-1.97, P=.049, Cohen d=0.28, 95% CI -0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03).ConclusionsFear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment.Trial registrationClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat).

Project description:ObjectivesSchools are experiencing an unprecedented mental health crisis, with teachers reporting high levels of stress and burnout, which has adverse consequences to their mental and physical health. Addressing mental and physical health problems and promoting wellbeing in educational settings is thus a global priority. This study investigated the feasibility and effectiveness of an 8-week Compassionate Mind Training program for Teachers (CMT-T) on indicators of psychological and physiological wellbeing.MethodsA pragmatic randomized controlled study with a stepped-wedge design was conducted in a sample of 155 public school teachers, who were randomized to CMT-T (n = 80) or a waitlist control group (WLC; n = 75). Participants completed self-report measures of psychological distress, burnout, overall and professional wellbeing, compassion and self-criticism at baseline, post-intervention, and 3-months follow-up. In a sub-sample (CMT-T, n = 51; WLC n = 36) resting heart-rate variability (HRV) was measured at baseline and post-intervention.ResultsCMT-T was feasible and effective. Compared to the WLC, the CMT-T group showed improvements in self-compassion, compassion to others, positive affect, and HRV as well as reductions in fears of compassion, anxiety and depression. WLC participants who received CMT-T revealed additional improvements in compassion for others and from others, and satisfaction with professional life, along with decreases in burnout and stress. Teachers scoring higher in self-criticism at baseline revealed greater improvements post CMT-T. At 3-month follow-up improvements were retained.ConclusionsCMT-T shows promise as a compassion-focused intervention for enhancing compassion, wellbeing and reducing psychophysiological distress in teachers, contributing to nurturing compassionate, prosocial and resilient educational environments. Given its favourable and sustainable effects on wellbeing and psychophysiological distress, and low cost to deliver, broader implementation and dissemination of CMT-T is encouraged.

Project description:ImportanceBlack women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population.ObjectiveTo compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms.Design, setting, and participantsIn this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women's Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study.InterventionsParticipants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep.Main outcomes and measuresThe primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE.ResultsA total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: -10.0 points; 95% CI, -11.2 to -8.7; SHUTi-BWHS: -9.3 points; 95% CI, -10.4 to -8.2) than those randomized to receive PE (-3.6 points; 95% CI, -4.5 to -2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (-10.4 points [95% CI, -11.4 to -9.4] vs -6.2 points [95% CI, -8.6 to -3.7]).Conclusions and relevanceIn this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep.Trial registrationClinicalTrials.gov Identifier: NCT03613519.

Project description:BackgroundIndividual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.ObjectiveThis paper presents a research protocol for strategies to examine the effects of guided ICBT.MethodsThis study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.ResultsThis study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.ConclusionsThis is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.Trial registrationUniversity Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522.International registered report identifier (irrid)DERR1-10.2196/49828.

Project description:Although 13-20% of American adolescents experience a depressive episode annually, no scalable primary care model for adolescent depression prevention is currently available. To study whether CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training) reduces the hazard for depression in at-risk adolescents identified in primary care, as compared to a general health education attention control (HE). The Promoting AdolescenT Health (PATH) study compares CATCH-IT and HE in a phase 3 single-blind multicenter randomized attention control trial. Participants were enrolled from 2012 to 2016 and assessed at 2, 6, 12, 18, and 24 months post-randomization. Primary care. Eligible adolescents were 13-18 years with subsyndromal depression and/or history of depression and no current depression diagnosis or treatment. Of 2,250 adolescents screened for eligibility, 446 participants completed the baseline interview and 369 were randomized into CATCH-IT (n=193) and HE (n=176). CATCH-IT is a 20-module (15 adolescent modules, 5 parent modules) online psychoeducation course that includes a parent program, supported by three motivational interviews. Time-to-event for depressive episode; depressive symptoms at 6 months. Mean age was 15.4 years, and 68% were female; 28% had both a past episode and subsyndromal depression; 12% had a past episode only, 59% had subsyndromal depression only, and 1% had borderline subsyndromal depression. The outcome of time-to-event favored CATCH-IT but was not significant with intention-to-treat analyses (N=369; unadjusted HR=0.59; 95% CI 0.27, 1.29; p=0.18; adjusted HR=0.53; 95% CI 0.23, 1.23, p=0.14). Adolescents with higher baseline CES-D10 scores showed a significantly stronger effect of CATCH-IT on time-to-event relative to those with lower baseline scores (p=0.04). For example, for a CES-D10 score of 15 (significant sub-syndromal depression), HR=0.20 (95% CI 0.05, 0.77), compared to CES-D10 of 5 (no sub-syndromal depression), HR=1.44 (95% CI, 0.41, 5.03). In both CATCH-IT and HE groups, depression symptoms declined and functional scores increased. CATCH-IT may be better than HE for preventing depressive episodes for at-risk adolescents with sub-syndromal depression. CATCH-IT may be a scalable approach to prevent depressive episodes in adolescents in primary care.

Dataset Information

Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled Trial.

Publications

Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled Trial.

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