Effects of Mindfulness-Based Cognitive Therapy in Pregnancy on Psychological Distress and Gestational Age: Outcomes of a Randomized Controlled Trial

Mindfulness ◽  
2021 ◽  
Author(s):  
Anna L. MacKinnon ◽  
Joshua W. Madsen ◽  
Gerald F. Giesbrecht ◽  
Tavis Campbell ◽  
Linda E. Carlson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Cognitive Therapy ◽  
Gestational Age ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
In Pregnancy

scholarly journals Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Lianne M. Tomfohr-Madsen ◽  
Tavis S. Campbell ◽  
Gerald F. Giesbrecht ◽  
Nicole L. Letourneau ◽  
Linda E. Carlson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Cognitive Therapy ◽  
Study Protocol ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
In Pregnancy

scholarly journals Fish Oil Supplementation in Pregnancy Increases Gestational Age, Size for Gestational Age, and Birth Weight in Infants: A Randomized Controlled Trial

2018 ◽  
Vol 149 (4) ◽  
pp. 628-634 ◽  
Author(s):  
Rebecca Kofod Vinding ◽  
Jakob Stokholm ◽  
Astrid Sevelsted ◽  
Bo L Chawes ◽  
Klaus Bønnelykke ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Pregnant Women ◽  
Gestational Age ◽  
Controlled Trial ◽  
Growth Curves ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Randomized Controlled ◽  
In Pregnancy

ABSTRACT Background Randomized trials have reported that supplementation with n–3 long-chain polyunsaturated fatty acids (LCPUFAs) in pregnancy can prolong pregnancy and thereby increase birth weight. Objective We aimed to examine the relations of n–3 LCPUFA supplementation in pregnancy with duration of pregnancy, birth weight, and size for gestational age (GA). Methods This was a double-blind randomized controlled trial conducted in 736 pregnant women and their offspring, from the Copenhagen Prospective Studies on Asthma in Childhood2010cohort. They were recruited between weeks 22 and 26 in pregnancy and randomly assigned to either of 2.4 g n–3 LCPUFA or control (olive oil) daily until 1 wk after birth. Exclusion criteria were endocrine, cardiovascular, or nephrologic disorders and vitamin D supplementation intake >600 IU/d. In this study we analyzed secondary outcomes, and further excluded twin pregnancies and extrauterine death. The primary outcome for the trial was persistent wheeze or asthma. Results The random assignment ran between 2008 and 2010. Six hundred and ninety-nine mother-infant pairs were included in the analysis. n–3 LCPUFA compared with control was associated with a 2-d prolongation of pregnancy [median (IQR): 282 (275–288) d compared with 280 (273–286) d, P = 0.02], a 97-g higher birth weight (mean ± SD: 3601 ± 534 g compared with 3504 ± 528 g, P = 0.02), and an increased size for GA according to the Norwegian population-based growth curves-Skjærven (mean ± SD: 49.9 ± 28.3 percentiles compared with 44.5 ± 27.6 percentiles, P = 0.01). Conclusion Supplementing pregnant women with n–3 LCPUFAs during the third trimester is associated with prolonged gestation and increased size for GA, leading to a higher birth weight in this randomized controlled trial. This trial was registered at clinicaltrials.gov as NCT00798226.

scholarly journals Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress—a randomized controlled trial protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Annette Holdgaard ◽  
Christine Eckhardt-Hansen ◽  
Thomas Lund ◽  
Christina Funch Lassen ◽  
Kirstine Lærum Sibiliz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Cardiac Rehabilitation ◽  
Cognitive Therapy ◽  
Cardiac Disease ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Intensive Group

Abstract Background Many patients with coronary artery disease (CAD) and valvular heart disease (VHD) suffer from psychological distress. Such stress is associated with increased morbidity, reduced quality of life and delayed return to work. European guidelines emphasize recognition and intervention, but evidence-based treatment options are limited and perceived as costly. The present study will test the effect of brief, group-based cognitive therapy as an adjunct to usual cardiac rehabilitation in a randomized design. Methods A total of 148 patients with CAD and/or VHD after surgical intervention and concomitant psychological distress (defined as HADS anxiety (A) or depression (D) score ≥8) will be randomized to either usual out-patient cardiac rehabilitation (CR) comprising an 8-week multidisciplinary programme or usual care supplemented by five group-based cognitive therapy sessions performed by trained CR nurses. A structured, standardized treatment manual will be used. Patients will be randomized 1:1 at three different sites. Additionally, a non-randomized sub-group of 40 matched patients without signs of psychological distress will be followed to investigate spontaneous variation in HADS. The primary outcome is Hospital Anxiety and Depression Score (HADS). Secondary outcomes are adherence to cardiac rehabilitation (CR), health-related quality of life measured by HeartQoL, time to return to work, adherence to lifestyle interventions and cardiovascular readmissions. Patients are followed up for 12 months. Discussion To our knowledge, this is the first randomized controlled trial (RCT) on patients with cardiac disease with an intensive group-based programme of cognitive therapy performed by CR nurses, which makes it affordable and widely implementable. The outcome will elucidate the feasibility and effect of cognitive therapy as an adjunct to CR in patients with post-surgery CAD and/or VHD and psychological distress and could possibly benefit patients with other heart conditions as well. The clinical trial complies with the Declaration of Helsinki. The trial has been approved by The Regional Research Ethics Committee (file number H-16042832) and The Danish Data Protection Agency. The results will be disseminated as original research in peer-reviewed manuscripts. Trial registration www.clinicaltrials.govNCT04254315. Retrospectively registered on 30 January 2020.

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

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

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