scholarly journals Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial

10.2196/14065 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e14065 ◽  
Author(s):  
Else Bisseling ◽  
Linda Cillessen ◽  
Philip Spinhoven ◽  
Melanie Schellekens ◽  
Félix Compen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Therapeutic Alliance ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Treatment Dropout ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Mental Well Being

Background Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. Objective This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions. Methods This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form. Results The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=−.39; P=.21). Therapeutic alliance increased over time in both conditions (F2,90=16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F1,91=0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=−.12; t114=−2.656; P=.01) and an increase in mental well-being (B=.23; t113=2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t113=2.261; P=.03). Conclusions A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. Trial Registration ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513

scholarly journals Development of the therapeutic alliance and its association with treatment outcome in internet-based Mindfulness-Based Cognitive Therapy (eMBCT) compared to group-based MBCT (MBCT) for distressed cancer patients (Preprint)

2019 ◽  
Author(s):  
Else Bisseling ◽  
Linda Cillessen ◽  
Philip Spinhoven ◽  
Melanie Schellekens ◽  
Félix Compen ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Psychological Distress ◽  
Therapeutic Alliance ◽  
Cognitive Therapy ◽  
Cancer Patients ◽  
Psychological Treatment ◽  
Well Being ◽  
Post Treatment ◽  
Treatment Dropout ◽  
Mental Well Being

BACKGROUND Mindfulness-Based Cognitive Therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based Mindfulness-based Cognitive Therapy (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance, i.e. the bond between therapist and patient, is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist-assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. OBJECTIVE The objectives of the present study were: (1) to explore whether early therapeutic alliance predicts treatment dropout in (e)MBCT; (2) to compare the development of the therapeutic alliance during eMBCT and MBCT; and (3) to examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at post-treatment in both conditions. METHODS The present study was part of a multicentre randomized controlled trial (RCT; n=245) on the effectiveness of (e)MBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (i.e. early therapeutic alliance), week 5 and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale (HADS) and mental-wellbeing, measured with the Mental Health Coninuum-short form (MHC-SF). RESULTS The strength of early therapeutic alliance did not predict treatment dropout in (e)MBCT (B=-0.39, p=.21). Therapeutic alliance increased over time in both conditions (F=16.46,Wilks’ λ=.732, p<.001). This increase did not differ between eMBCT and MBCT (F=0.114, p=.74). Therapeutic alliance at week 2 predicted a reduction of psychological distress (B=-.126, t=-2.656, p=.01) and an increase of in mental well-being (B=.234, t=2.651, p=.01) at post-treatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at post-treatment in MBCT but not in eMBCT(B=.217, t=2.261, p=.03). CONCLUSIONS A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at post-treatment in both conditions. Interestingly, the strength of therapeutic alliance is appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. CLINICALTRIAL NCT02138513 https://clinicaltrials.gov/ct2/show/NCT02138513

scholarly journals UPRIGHT, a resilience-based intervention to promote mental well-being in schools: study rationale and methodology for a European randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Carlota Las Hayas ◽  
◽  
Irantzu Izco-Basurko ◽  
Ane Fullaondo ◽  
Silvia Gabrielli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Controlled Trial ◽  
Well Being ◽  
Simulation Modelling ◽  
European Regions ◽  
Horizon 2020 ◽  
Randomized Controlled ◽  
Research And Innovation ◽  
Mental Well Being

Abstract Background Adolescence is crucial period for laying the foundations for healthy development and mental well-being. The increasing prevalence of mental disorders amongst adolescents makes promotion of mental well-being and prevention interventions at schools important. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is designed as a whole school approach (school community, students and families) to promote a culture of mental well-being and prevent mental disorders by enhancing resilience capacities. The present article aims at describing the rationale, conceptual framework, as well as methodology of implementation and evaluation of the UPRIGHT intervention. Methods UPRIGHT project is a research and innovation project funded by the European Union’s Horizon 2020 Research and Innovation programme under grant agreement No. 754919 (Duration: 48 months). The theoretical framework has been developed by an innovative and multidisciplinary approach using a co-creation process inside the UPRIGHT Consortium (involving seven institutions from Spain, Italy, Poland, Norway, Denmark, and Iceland). Resulted is the UPRIGHT programme with 18 skills related to 4 components: Mindfulness, Coping, Efficacy and Social and Emotional Learning. Among the five Pan-European regions, 34 schools have been currently involved (17 control; 17 intervention) and around 6000 adolescents and their families are foreseen to participate along a 3-year period of evaluation. Effectiveness of the intervention will be evaluated as a randomized controlled trial including quantitative and qualitative analysis in the five Pan-European regions representative of the cultural and socioeconomic diversity. The cost-effectiveness assessment will be performed by simulation modelling methods. Discussion We expect a short- to medium-term improvement of mental well-being in adolescents by enhancing resilience capacities. The study may provide robust evidence on intrapersonal, familiar and social environmental resilience factors promoting positive mental well-being. Trial registration ClinicalTrials.gov Identifier: NCT03951376. Registered 15 May 2019.

scholarly journals Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Ernst Bohlmeijer ◽  
Jannis Kraiss ◽  
Marijke Schotanus-Dijkstra ◽  
Peter ten Klooster
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Sensitivity Analyses ◽  
Control Group ◽  
Multiple Mediation ◽  
Randomized Controlled ◽  
Gratitude Intervention ◽  
Mental Well Being ◽  
Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial

2017 ◽  
Vol 14 (5) ◽  
pp. 336-343 ◽  
Author(s):  
Mercedes Vélez-Toral ◽  
Débora Godoy-Izquierdo ◽  
Nicolás Mendoza Ladrón de Guevara ◽  
Carlos de Teresa Galván ◽  
Alberto Salamanca Ballesteros ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Metabolic Health ◽  
Metabolic Status ◽  
Control Group ◽  
Randomized Controlled ◽  
Health And Fitness ◽  
Mental Well Being

Background:This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program.Methods:A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed.Results:After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility.Conclusions:Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

scholarly journals A Mobile Phone and Web-Based Intervention for Improving Mental Well-Being in Young People With Type 1 Diabetes: Design of a Randomized Controlled Trial

2015 ◽  
Vol 4 (2) ◽  
pp. e50 ◽  
Author(s):  
Janine Clarke ◽  
Veronica Vatiliotis ◽  
Charles F Verge ◽  
Jane Holmes-Walker ◽  
Lesley V Campbell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Young People ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Well Being ◽  
Web Based ◽  
Randomized Controlled ◽  
Mental Well Being

scholarly journals A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial

10.2196/23655 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e23655
Author(s):  
Jin Han ◽  
Lauren McGillivray ◽  
Quincy JJ Wong ◽  
Aliza Werner-Seidler ◽  
Iana Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Young People ◽  
Controlled Trial ◽  
Well Being ◽  
Suicidal Thoughts ◽  
Randomized Controlled ◽  
Self Help ◽  
Mental Well Being

Background Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. Objective This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. Methods This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. Results The trial recruitment started in May 2020. Data collection is currently ongoing. Conclusions This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366. International Registered Report Identifier (IRRID) PRR1-10.2196/23655

scholarly journals Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Philippe Deruelle ◽  
Sophie Lelorain ◽  
Sylvie Deghilage ◽  
Emmanuelle Couturier ◽  
Elodie Guilbert ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Link Type ◽  
Multicenter Randomized Controlled Trial ◽  
In Pregnancy

Abstract Background Pre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications. Methods Electronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum. The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). Secondary outcomes will consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity. Post-natal outcomes will be duration of breastfeeding, maternal weight retention and child weight at postnatal visit. Discussion The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy. Trial registration ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.

Technology-Assisted Telephone Intervention for Employees with Decreased Mental Well-Being: A Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Salla Tuulikki Muuraiskangas ◽  
Anita Marianne Honka ◽  
Ulla-Maija Junno ◽  
Hannu Nieminen ◽  
Jouni Kaartinen
Keyword(s):  
Randomized Controlled Trial ◽  
Time Use ◽  
Research Group ◽  
Controlled Trial ◽  
Maintenance Phase ◽  
Well Being ◽  
Telephone Intervention ◽  
Intensive Phase ◽  
Randomized Controlled ◽  
Mental Well Being

BACKGROUND Health interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions. However, the optimal combination of human and technology involvement is unclear. OBJECTIVE The aim of the study was to compare the intervention effectiveness and time use of coaches (as an approximation of intervention cost) between a technology-assisted telephone intervention and a traditional telephone intervention for stress management. METHODS A two-arm, randomized controlled trial of nine months (four months intensive and five months maintenance) for stress management was conducted. Participants were recruited online through a regional occupational health care provider in Finland, and randomized equally to a research (technology-assisted telephone intervention) and a control (telephone intervention) group. For both groups, coaching was provided by three occupational health coaches. The coaching methodology was based on habit formation, motivational interviewing and the transtheoretical model. For the research group, technology (web-based tools and wearables) was supporting both the coaches and participants in identifying behaviour change needs (goal setting), setting the initial coaching plan by recommending personalized coaching tasks, progress monitoring, and communication. Technology had greater role in the intensive phase. During the maintenance, technology was mostly used to replace coaching calls. Primary outcomes were participants’ self-assessed mental well-being (WorkOptimum index) and the self-reported time use of coaches. Secondary outcomes included adherence and self-assessed satisfaction with coaching. RESULTS Altogether, 49 eligible participants were randomized to the research (N=24) and control (N=25) groups. Most of the participants were middle-aged (mean 46.26 years, SD 9.74) and females (95.92%, 47/49). Mental well-being improved significantly in both groups (WorkOptimum from ‘at risk’ to ‘good’ P <.001), but no between-group differences were observed in the end (-0.47 vs -0.44, P=.56). The total time use of coaches did not differ significantly between the groups (366.0 min vs. 343.0 min, P=.48). Regarding adherence, the dropout rate was 12.50% (3/24) for the research and 24.00% (6/25) for the control group; the mean adherence rate to coaching calls was 91.67% and 85.50% for the two groups, respectively; the frequency of performing the coaching tasks was similar for both groups after both phases; and the diligence in performing coaching tasks during the intensive phase was better for the research group (5.0 vs. 4.0, P=.03), but no difference was observed for the maintenance phase. Satisfaction was significantly higher in the research group during the intensive phase (5.0 vs 4.0, P<.001), but not during the maintenance phase. CONCLUSIONS Technology-assisted telephone intervention seems to be as effective as the traditional telephone intervention but does not necessarily reduce time use of coaches with the realized human-technology involvement combination. Offering digital tools to complement telephone coaching seems to increase satisfaction with coaching. CLINICALTRIAL ClinicalTrials.gov NCT02445950

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