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Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial.

ABSTRACT: INTRODUCTION:The death of a significant person through suicide is a very difficult experience and can have long-term impact on an individual's psychosocial and physical functioning. However, there are only few studies that have examined the effects of interventions in suicide survivors. In the present study, we examine an online-group intervention for people bereaved by suicide using a group-webinar. METHODS:The intervention was developed based on focus groups with the target group. The cognitive-behavioral 12-module webinar-based group intervention focuses on suicide bereavement-related themes such as feelings of guilt, stigmatization, meaning reconstruction and the relationship to the deceased. Further, the webinar includes testimonial videos and psychoeducation. The suicide survivors are randomized to the intervention or the waiting list in a group-cluster randomized controlled trial. Primary outcomes are suicidality (Beck Scale for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory). DISCUSSION:Previous studies of Internet-based interventions for the bereaved were based on writing interventions showing large treatment effects. Little is known about the use of webinars as group interventions. Advantages and challenges of this novel approach of psychological interventions will be discussed. TRIAL REGISTRATION:German Clinical Trials Register, DRKS00014426. Registered on 12 April 2018. PROTOCOL VERSION:3, 21.10.2019.

SUBMITTER: Wagner B

PROVIDER: S-EPMC6951011 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial.

Wagner Birgit B Hofmann Laura L Maaß Ulrike U

Trials 20200108 1

<h4>Introduction</h4>The death of a significant person through suicide is a very difficult experience and can have long-term impact on an individual's psychosocial and physical functioning. However, there are only few studies that have examined the effects of interventions in suicide survivors. In the present study, we examine an online-group intervention for people bereaved by suicide using a group-webinar.<h4>Methods</h4>The intervention was developed based on focus groups with the target grou ...[more]

PMID: 31915044

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Project description:BackgroundPostpartum depression (PPD) has a 20% 3-month prevalence rate. The consequences of PPD are significant for the mother, infant, and the family. There is a need for preventive interventions for PPD, which are effective and accessible; however, many barriers exist for women who attempt to access perinatal depression prevention programs. Internet interventions for the treatment and prevention of depression are widely accepted as efficacious and may overcome some of the issues pertaining to access to treatment barriers perinatal women face. However, internet interventions offered without any human support tend to have low adherence but positive outcomes for those who do complete treatment. Internet support groups often have high levels of adherence but minimal data supporting efficacy as a treatment for depression. Taken together, these findings suggest that combining the treatment components of individual interventions with the support provided by an internet support group might create an intervention with the scalability and cost-effectiveness of an individual intervention and the better outcomes typically found in supported interventions.ObjectivesThis study aimed to describe the development of a cognitive behavioral therapy (CBT) internet intervention with peer support to prevent PPD and examine preliminary depression and site usage outcomes.MethodsUser-centered design groups were used to develop the internet intervention. Once the intervention was developed, women who were 20 to 28 weeks pregnant with symptoms of depression (Patient Health Questionnaire-8 scores of 5-14) but who had no major depression diagnosis were enrolled in a randomized controlled trial (RCT) to compare 8 weeks of a CBT-based internet intervention with peer support to an individual internet intervention designed to prevent PPD. Assessments took place at baseline, 4 weeks, 8 weeks (end of treatment), and then 4 weeks and 6 weeks postpartum.ResultsA total of 25 women were randomized. Of these, 24 women completed the RCT. Patient Health Questionnaire-9 scores at 6 weeks postpartum remained below the clinical threshold for referral for treatment in both groups, with depression measures showing a decrease in symptoms from baseline to postpartum. At 6 weeks postpartum, only 4% (1/24) met the criteria for PPD. There was no difference between groups in adherence to the intervention, with an average of 14.55 log-ins over the course of treatment.ConclusionsResults suggest women were responsive to both peer support and individual internet interventions to prevent PPD and that peer support may be a useful feature to keep participants adherent.Trial registrationClinicalTrials.gov NCT02121015; https://clinicaltrials.gov/ct2/show/NCT02121015 (archived by WebCite at http://www.webcitation.org/765a7qBKy).

Project description:BackgroundFamilies raising children with disabilities assume risks to their health and lives. Therefore, it is necessary to support these families to improve family empowerment, which is the ability of these families to control their own lives and to promote the collaborative raising of children with disabilities. This is the first online intervention program focusing on the empowerment of families raising children with disabilities who live at home in Japan.MethodThe program consists of four online peer-based group sessions. Moreover, the families engage in several activities in stages wherein they discover their own issues, find measures to resolve them, and take action, while visualizing interfamily relationships, including social resources, and the status of their family life, with facilitators and other peer members. This study is a non-randomized, waitlist-controlled trial. It compares the results of the intervention group (early group) and the waitlist-controlled group (delayed group). The participants are allocated to the early or delayed group in the order of their applications. The main outcome is family empowerment. Other outcomes are the caregiver burden, self-reported capability to use social resources, self-compassion, and the quality of life (QOL) of primary caregivers. The timeline of the online outcome evaluation is as follows: the initial evaluation (Time 1 [T1]) is conducted before the start of the first early group program, and post-intervention evaluation (Time 2 [T2]) is conducted immediately (within 1 week) after the early group completes all four sessions (4 weeks) of the program. Follow-up evaluation (Time 3 [T3]) is conducted 4 weeks after the post-intervention evaluation. This timing is the same in the delayed group, but the delayed group will attend the program after a 4-week waiting period, compared to the early group.DiscussionThe intention is to evaluate whether the provision of the program developed in this study and the evaluation test design are feasible and to verify the efficacy of this program.Trial registrationThe UMIN Clinical Trials Registry (UMIN000044172), registration date: May 19, 2021.

Project description:Marital bereavement and separation or divorce are among the most stressful critical life events in later life. These events require a dissolution of social and emotional ties, adjustments in daily routine and changes in identity and perspectives for the future. After a normative grief or distress reaction, most individuals cope well with the loss. However, some develop a prolonged grief reaction. Internet-based self-help interventions have proved beneficial for a broad range of disorders, including complicated grief. Based on the task model and the dual-process model of coping with bereavement, we developed a guided internet-based self-help intervention for individuals who experienced marital bereavement, separation or divorce at least 6 months prior to enrolment. The intervention consists of 10 text-based self-help sessions and one supportive email a week. The primary purpose of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting control group. The secondary purpose is to compare the effects in bereaved and separated participants. Furthermore, we aim to analyze other predictors, moderators and mediators of the outcome, such as age, psychological distress and intensity of use of the intervention.The design is a randomized controlled trial with a waiting control condition of 12 weeks and a 24-weeks follow-up. At least 72 widowed or separated participants will be recruited via our study website and internet forums. Primary outcomes are reductions in grief symptoms, depression and psychological distress. Secondary outcome measures are related to loneliness, satisfaction with life, embitterment and the sessions.The trial will provide insights into the acceptance and efficacy of internet-based interventions among adults experiencing grief symptoms, psychological distress and adaptation problems in daily life after spousal bereavement, separation or divorce. Findings will add to existing knowledge by (1) evaluating an internet-based intervention specifically designed for spousal bereavement and its consequences; (2) testing whether this intervention is equally effective for individuals after separation or divorce; and (3) suggesting adaptations to improve the efficacy of the intervention, selective indication and adaptations for different needs.ClinicalTrials.gov, NCT02900534 . Registered on 1 September 2016.

Project description:BackgroundBereavement due to cancer increases the risk of prolonged grief disorder. However, specialized treatment options for prolonged grief after a loss due to illness are still scarce.ObjectiveThe aim of this study is to extend previous findings by evaluating a web-based cognitive behavioral intervention with asynchronous therapist support, consisting of structured writing tasks adapted specifically for prolonged grief after cancer bereavement.MethodsThe intervention was evaluated in a purely web-based randomized waitlist-controlled trial. Open-access recruitment of participants was conducted on the web. Prolonged grief (Inventory of Complicated Grief), depression, anxiety, posttraumatic stress, posttraumatic growth, somatization, sleep quality, and mental and physical health were assessed on the web via validated self-report measures.ResultsA total of 87 participants were randomized into the intervention group (IG; 44/87, 51%) or the waitlist control group (43/87, 49%). Of the participants, 7% (6/87) dropped out of the study (5/44, 11%, in the IG). Of the 39 completers in the IG, 37 (95%) completed all intervention tasks. The intervention reduced symptoms of prolonged grief (intention-to-treat: P<.001; η2=0.34; Cohen d=0.80) to a clinically significant extent. It had favorable effects on depression, anxiety, posttraumatic stress, posttraumatic growth, and overall mental health but not on somatization, sleep quality, or physical health.ConclusionsThe web-based intervention for prolonged grief after cancer bereavement is effective in reducing symptoms of prolonged grief disorder and accompanying syndromes in a timely, easily realizable manner and addresses specific challenges of bereavement to illness. Considering web-based approaches in future mental health care policy and practice can reduce health care gaps for those who are bereaved to cancer.Trial registrationGerman Clinical Trial Register U1111-1186-6255; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011001.

Project description:BackgroundMobile health, the use of mobile technology in delivering health care, has been found to be effective in changing health behaviors, including improving breastfeeding practices in postpartum women. With the widespread use of smartphones and instant messaging apps in Hong Kong, instant messaging groups could be a useful channel for delivering breastfeeding peer support.ObjectiveThe aim of this paper is to study the feasibility and acceptability of an online instant messaging peer support group by trained peer counselors on improving breastfeeding outcome in primiparous women in Hong Kong.MethodsA two-arm, assessor-blind, randomized controlled feasibility study will be conducted on 40 primiparous women with the intention to breastfeed. Participants are recruited from the antenatal obstetrics and gynecology clinic of a public hospital in Hong Kong and randomly assigned at a 1:1 ratio to either intervention or control group. The intervention group receives peer support in an online instant messaging group with trained peer counselors on top of standard care, whereas the control group receives standard care. Breastfeeding outcome will be assessed for 6 months post partum or until weaned. The breastfeeding status, the proportion and duration of exclusive and any breastfeeding in each group, and the self-efficacy and attitude of participants will be assessed. The feasibility and acceptability of the study would also be assessed in preparation for a full randomized controlled trial.ResultsThis study (protocol version 1 dated January 5, 2021) has been reviewed and approved by the institutional review board of the University of Hong Kong, Hospital Authority Hong Kong West Cluster (reference UW 21-039), on January 26, 2021. Data collection is ongoing and expected to be completed in December 2021. The findings will be updated on clinical trial registry and disseminated in peer-reviewed journals.ConclusionsThis study aims to assess the feasibility and effectiveness of an online instant messaging peer support group in improving the breastfeeding outcome of primiparous women in Hong Kong. Its findings could inform the feasibility of a full-scale trial with this intervention design.Trial registrationClinicalTrials.gov NCT04826796; https://clinicaltrials.gov/ct2/show/NCT04826796.International registered report identifier (irrid)DERR1-10.2196/32338.

Project description:BackgroundOppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting.Methods/designThis study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses.DiscussionThe aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems.Trial registrationClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Dataset Information

Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial.

Publications

Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial.

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