scholarly journals Twelve-Month Follow-up of the U-CARE Heart Randomized Controlled Trial: Internet-Based Cognitive Behavioral Therapy (iCBT) for Patients Reporting Symptoms of Anxiety and Depression after Myocardial Infarction (Preprint)

JMIR Cardio ◽  
10.2196/25465 ◽  
2020 ◽  
Author(s):  
Sophia Monica Humphries ◽  
John Wallert ◽  
Fredrika Norlund ◽  
Emma Wallin ◽  
Gunilla Burell ◽  
...  
10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  

Background Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care. Objective This 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. Methods This 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. Results We 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). Conclusions Fear 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 Registration ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)


2010 ◽  
Vol 104 (7) ◽  
pp. 986-994 ◽  
Author(s):  
Minna J. Hynninen ◽  
Nina Bjerke ◽  
Ståle Pallesen ◽  
Per S. Bakke ◽  
Inger Hilde Nordhus

2018 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  

BACKGROUND Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth (FOB) should be handled in clinical care. OBJECTIVE This randomized controlled trial (RCT) aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care (SC) on the levels of FOB in a sample of pregnant women reporting FOB. METHODS This nonblinded, multicenter RCT 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 (UP) and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their FOB and find new ways of coping with difficult thoughts and emotions. SC was offered in the three different study regions. The primary outcome was self-assessed levels of FOB, measured using the Fear of Birth Scale (FOBS). RESULTS We included 258 pregnant women reporting clinically significant levels of FOB (guided ICBT group, 127; SC 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 FOB 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 FOB (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 FOB over time was found (P=<.001), along with a significant interaction between time and intervention, showing a larger reduction in FOB in the guided ICBT group over time (F1,192.538=4.96, P=.03). CONCLUSIONS FOB 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. CLINICALTRIAL ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)


SLEEP ◽  
2019 ◽  
Vol 42 (10) ◽  
Author(s):  
Philip Cheng ◽  
David A Kalmbach ◽  
Gabriel Tallent ◽  
Christine Lm Joseph ◽  
Colin A Espie ◽  
...  

Abstract Study Objectives Insomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period. Methods Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up. Results At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition. Conclusion dCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose–response requirements and further characterize mechanisms of action of dCBT-I for depression prevention. Clinical Trial Sleep to Prevent Evolving Affective Disorders; NCT02988375.


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