Effectiveness of a psycho-educational intervention for expecting parents to prevent postpartum parenting stress, depression and anxiety: a randomized controlled trial

Abstract Background The first months postpartum can be challenging for parents, leading to elevated symptoms of parenting stress, depression and anxiety. In turn, distressed parents are at higher risk for providing suboptimal quality of caregiving. As psychoeducational interventions can be effective in reducing psychological distress, the goal of this randomized controlled trial was to examine the effectiveness of low-intensity universal psychoeducational program to prevent postpartum parenting stress, and to enhance parental well-being and caregiving quality. Method Between 26 and 34 weeks of pregnancy, 138 pregnant women and 96 partners were randomized to the intervention or a waitlist control group. The intervention consisted of a booklet, a video, a home visit, and a telephone call. Information was provided on (1) sensitive responsiveness, adapting to the parental role, and attending to own needs; (2) crying patterns; (3) feeding (arrangements); and (4) sleeping (arrangements). The primary outcome was parenting stress postpartum. Secondary outcomes were additional measures of distress (depression and anxiety), parental well-being, and caregiving quality. Results Both groups showed a rise in distress after birth. No between-group differences were observed on parenting stress, nor on the secondary outcomes. The intervention was rated as useful and of added value by the parents. Conclusion This study offered no evidence that our universal prevention program was effective in decreasing parental distress or in increasing caregiving quality. However, parents found aspects of the intervention useful. More research is needed, including a longer period of follow-up as well as observational measures of parents’ responsiveness. Trial registration This trial has been registered on 15 September 2016 in the Netherlands National Trial Register, ID: NTR6065, https://www.trialregister.nl/trial/5782.

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Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial (Preprint)

10.2196/preprints.27615 ◽

2021 ◽

Author(s):

Tomohisa Ando ◽

Rintaro Mori ◽

Kenji Takehara ◽

Mari Asukata ◽

Shuichi Ito ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Atopic Dermatitis ◽

Parenting Stress ◽

Short Form ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stress Index ◽

Control Group ◽

Randomized Controlled

BACKGROUND Electronic health (eHealth) for infants and mothers is a current focus of attention, but its effectiveness has rarely been examined in Japan. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, is one of the most common conditions. For mothers, parenting stress, which adversely affects mothers’ and children’s well-being, is one of the biggest problems in the postpartum period; this requires a national solution in Japan. OBJECTIVE To evaluate the effectiveness of pediatric teleconsultation for preventing atopic dermatitis in infants and reducing parenting stress in mothers in Japan. METHODS The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in Yokohama City Sakae Ward in Japan were recruited when they submitted birth cards to the ward, received the explanation, and completed online informed consent on the website for this trial. Eligible pairs of infant and mother were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in both the intervention and control groups received routine postnatal care from the local government services. In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters without any charge from the date of registration until the infant was 4 months of age. Primary outcomes were (i) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party’s criteria; and (ii) parenting stress and mental status in mothers, assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected via the ward office staff and researcher at the 4-month checkup. RESULTS The prevalence of AD in infants was significantly lower in the intervention group than in the control group at the 4-month checkup (20% vs. 33%, P=.03; relative risk ratio, 0.614 [95% confidence interval, 0.406 to 0.927]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the two groups. CONCLUSIONS This is the first randomized controlled trial demonstrating that a combined pediatric service with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. Pediatric eHealth will become a new strategy for preventing AD. CLINICALTRIAL UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022

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A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

International Psychogeriatrics ◽

10.1017/s1041610204000055 ◽

2004 ◽

Vol 16 (1) ◽

pp. 33-49 ◽

Cited By ~ 80

Author(s):

Claudia K. Y. Lai ◽

Iris Chi ◽

Jeanie Kayser-Jones

Keyword(s):

Randomized Controlled Trial ◽

Nursing Home ◽

Repeated Measures ◽

Comparison Group ◽

Controlled Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Well Being ◽

Control Group ◽

Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

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A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/24264 ◽

2020 ◽

Vol 9 (12) ◽

pp. e24264

Author(s):

Hayley Wright ◽

Faith Martin ◽

Wendy Clyne ◽

Cain C T Clark ◽

Michael McGillion ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Data Collection ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Wait List ◽

Care Providers ◽

Randomized Controlled ◽

Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

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Effects of Hatha Yoga on caregivers of children and adolescents with cancer: a randomized controlled trial

Escola Anna Nery ◽

10.1590/2177-9465-ean-2019-0133 ◽

2020 ◽

Vol 24 (1) ◽

Author(s):

Marina Lima Daleprane Bernardi ◽

Maria Helena Costa Amorim ◽

Luciane Bresciane Salaroli ◽

Eliana Zandonade

Keyword(s):

Randomized Controlled Trial ◽

Children And Adolescents ◽

Controlled Trial ◽

Well Being ◽

Hatha Yoga ◽

Control Group ◽

Anxiety State ◽

Clinical Group ◽

Subjective Well Being ◽

Randomized Controlled

Abstract Objective: To assess the effects of a Hatha Yoga intervention on anxiety, subjective well-being, and attention levels of caregivers of children and adolescents with cancer, admitted to a public hospital in the city of Vitória, state of Espírito Santo, Brazil. Methods: A randomized controlled trial was performed. Thirty-six volunteers were allocated to clinical (participated in 4 to 6 Hatha Yoga practices) or control groups and answered the questionnaires State-Trait Anxiety Inventory, Subjective Well-Being Scale, and Mindfulness Attention Awareness Scale before and after the intervention period. Mann-Whitney and Wilcoxon nonparametric analyses were performed to compare the groups to each other and at different moments. Results: The individuals' moderate anxiety state decreased in the clinical (p = 0.001) and control (p = 0.014) groups so that while the control group continued to present moderate anxiety, the clinical group presented low anxiety after the intervention. Positive affects increased, and adverse effects decreased in the clinical group (p <0.05). There were no relevant changes in satisfaction with life and attention levels in the two groups (p> 0.05). Conclusion and implications for practice: Hatha Yoga is a useful tool for healthcare professionals and caregivers in short-term hospital care to reduce anxiety and improve subjective well-being.

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Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.27138 ◽

2021 ◽

Author(s):

Justine Dol ◽

Megan Aston ◽

Douglas McMillan ◽

Gail Tomblin Murphy ◽

Marsha Campbell-Yeo

Keyword(s):

Social Support ◽

Randomized Controlled Trial ◽

Postpartum Depression ◽

Self Efficacy ◽

Controlled Trial ◽

Text Message ◽

Psychosocial Outcomes ◽

Control Group ◽

Depression And Anxiety ◽

Randomized Controlled

BACKGROUND Women experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum. OBJECTIVE The primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program. METHODS This will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant’s age and the woman’s self-selected preference for breastfeeding or formula feeding and tailored with the infant’s name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant’s date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention. RESULTS Recruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022. CONCLUSIONS This study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program. CLINICALTRIAL ClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27138

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

Frontiers in Psychology ◽

10.3389/fpsyg.2021.799447 ◽

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.

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Effect of Yoga versus Light Exercise to Improve Well-Being and Promote Healthy Aging among Older Adults in Central India: A Study Protocol for a Randomized Controlled Trial

Geriatrics ◽

10.3390/geriatrics4040064 ◽

2019 ◽

Vol 4 (4) ◽

pp. 64 ◽

Cited By ~ 4

Author(s):

Choudhary ◽

Pathak ◽

Manickam ◽

Purohit ◽

Rajasekhar ◽

...

Keyword(s):

Physical Activity ◽

Older Adults ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Central India ◽

Well Being ◽

Medical College ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Multiple Health

Background: Aging is a natural process associated with many functional and structural changes. These changes may include impaired self-regulation, changes in tissues and organs. Aging also affects mood, physical status and social activity. There are adverse changes in cognitive behavior, perceived sensation and thinking processes. Regular physical activity can alleviate many health problems; yet, many older adults are inactive. Yoga is one of the scientific and popular lifestyle practice considered as the integration of mind, body and soul. Results of previous studies reported positive effects of yoga on multiple health outcomes in elderly. However, there is scarcity of scientific information where yoga’s effect is examined on over well-being and on multiple health outcomes simultaneously in elderly. This protocol describes methods for a 12-week yoga-based intervention exploring the effects of yoga on well-being in physically inactive elderly living in community. Methods and analysis: This two group parallel single blind randomized controlled trial that will be conducted at a designated facility of R.D. Gardi Medical College, Ujjain, Madhya Pradesh, Central India. A 12-week 60-min yoga intervention three times weekly is designed. Comparison group participants will undergo a 60-min program comprising light exercise focusing on conventional stretching to improve mobility. After screening, 144 participants aged 60–80 years will be recruited. The primary outcome is subjective well-being. Secondary outcomes include mobility, fall risk, cognition, anxiety and depression, mood and stress, sleep quality, pain, physical activity/sedentary behavior and cardio-metabolic risk factors. Assessments will be conducted at baseline (0 week), after the intervention (12+1 week) and at follow-up (36+1 week). Intention-to-treat analyses with mixed linear modeling will be applied. Discussion: Through this trial, we aim to determine whether elderly people in the intervention group practicing yoga show more favorable primary (well-being) and secondary outcomes than those in the light exercise focusing on conventional stretching group. We assume that yoga may be practiced to maintain health, reduce particular symptoms commonly associated with skeletal pain, assist in pain relief and enhance well-being. We anticipate that practicing yoga will improve well-being and mental health and may lead to significant improvement in depression, pain and sleep quality.Ethics and dissemination: This study is approved by the Institutional Ethics Committee of R.D. Gardi Medical College, Ujjain, IEC Ref No. 09/2018. All participants would be provided with written and verbal information about the purpose of the project and would be free to withdraw from the study at any time. Refusal to participate in the study would not have any negative consequences. Confidentiality of the information of each participant would be ensured. Knowledge obtained would be disseminated to stakeholders through workshops, meetings and relevant scientific conferences.Trial Registration: The trial is prospectively registered with the Indian Council of Medical Research Trial Registry CTRI/2018/07/015051.

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Family Minds: A randomized controlled trial of a group intervention to improve foster parents’ reflective functioning

Development and Psychopathology ◽

10.1017/s095457942000214x ◽

2021 ◽

pp. 1-15

Author(s):

Tina Adkins ◽

Samantha Reisz ◽

Dilara Hasdemir ◽

Peter Fonagy

Keyword(s):

Randomized Controlled Trial ◽

Parenting Stress ◽

Group Intervention ◽

Internalizing Symptoms ◽

Foster Parents ◽

Controlled Trial ◽

Reflective Functioning ◽

Internalizing Behavior ◽

Control Group ◽

Randomized Controlled

AbstractFamily Minds is a brief group psychoeducational parenting intervention designed to increase the reflective functioning (RF) and mentalization skills of foster parents. RF is important for foster parents who have to build relationships with children whose adverse experiences increase their risk for psychosocial challenges. A randomized controlled trial (RCT) for Family Minds was conducted in Texas with 89 foster parents. The main aims of this study were to examine whether the intervention could significantly increase the RF/mentalization skills of the foster parents and decrease their parenting stress. After 6 weeks, compared with the control group, intervention foster parents improved their RF via a lowering of pre-mentalizing and also significantly decreased parenting stress related to parent–child dysfunctional interactions. Other measures of RF and parenting stress showed no significant differences between groups. Foster child behavior was not significantly different between groups, although data at 6 months showed a possible lowering of internalizing symptoms for children of intervention parents. This RCT provides some encouraging evidence that Family Minds may increase RF in foster parents, improve parental sensitivity and their ability to emotionally regulate, decrease parenting stress related to challenging interactions with their foster children, and possibly decrease children's internalizing behavior.

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