scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: A Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

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)

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial

10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

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)

scholarly journals Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna L. MacKinnon ◽  
Joshua W. Madsen ◽  
Ashley Dhillon ◽  
Elizabeth Keys ◽  
Gerald F. Giesbrecht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Sleep Problems ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
The Impact ◽  
In Pregnancy

Abstract Background Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). Methods A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). Discussion CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. Trial registration ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

scholarly journals A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women

2020 ◽  
Vol 72 ◽  
pp. 82-92 ◽  
Author(s):  
David A. Kalmbach ◽  
Philip Cheng ◽  
Louise M. O'Brien ◽  
Leslie M. Swanson ◽  
Roopina Sangha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled

scholarly journals Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial

SLEEP ◽  
2019 ◽  
Vol 42 (10) ◽  
Author(s):  
Philip Cheng ◽  
David A Kalmbach ◽  
Gabriel Tallent ◽  
Christine Lm Joseph ◽  
Colin A Espie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Relative Rate ◽  
Cognitive Behavioral ◽  
Future Research ◽  
Depression Prevention ◽  
Randomized Controlled

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.

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

2019 ◽  
Vol 87 (6) ◽  
pp. 521-529 ◽  
Author(s):  
Margo de Jonge ◽  
Claudi L. H. Bockting ◽  
Martijn J. Kikkert ◽  
Maarten K. van Dijk ◽  
Digna J. F. van Schaik ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Cognitive Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled
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