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An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Brodbeck J

PROVIDER: S-EPMC5237350 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial.

Brodbeck Jeannette J Berger Thomas T Znoj Hans Joerg HJ

Trials 20170113 1

<h4>Background</h4>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 o ...[more]

PMID: 28086836

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Project description:BACKGROUND:Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. OBJECTIVE:To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. METHODS:A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. RESULTS:Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). CONCLUSIONS:Findings will contribute to the literature on treatment of perfectionism, the effect of treating perfectionism on depression and anxiety, and the efficacy of Internet-based guided self-help interventions. CLINICALTRIAL:ClinicalTrials.gov NCT02756871; https://clinicaltrials.gov/ct2/show/NCT02756871 (Archived by WebCite at http://www.webcitation.org/6lmIlSRAa).

Project description:BackgroundMigration is a challenging life transition that may be a source of various problems related to well-being and mental health. However, the psychological adaptation of migrants may be potentially facilitated by social self-efficacy-the beliefs in one's ability to initiate and maintain interpersonal relationships. Previous research suggests that social self-efficacy is positively related to adjustment and negatively related to loneliness, depression, and psychological distress. Research also confirms that self-efficacy beliefs can be effectively enhanced using Internet-based interventions. These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to sources of self-efficacy beliefs: mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. Users complete increasingly challenging tasks that encourage them to interact with their environment. The aim of this trial was to investigate the efficacy of the New in Town intervention.MethodsThe efficacy of the New in Town intervention will be tested in a two-arm randomized controlled trial with a waitlist control group. Social self-efficacy will be the primary outcome. Secondary outcomes will include loneliness, perceived social support, and satisfaction with life. Additionally, we will measure user experience among participants allocated to the experimental group. We aim to recruit a total of N = 280 participants aged at least 18 years who have changed their place of residence in the last 6 months and have an Internet connection. Participants will be assessed at baseline, 3-week post-test, and 8-week follow-up.DiscussionThe trial will provide insights into the efficacy of Internet-based self-help interventions in increasing social self-efficacy. Given that the intervention works, New in Town could provide an easily accessible support option for internal migrants in Poland.Trial registrationThe trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.

Project description:BackgroundIn spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population.ObjectiveThis pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking-related impairment, dimensions of skin picking, and general psychological impairment.MethodsA two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report.ResultsThe willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found.ConclusionsThis study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial.Trial registrationGerman Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236.International registered report identifier (irrid)RR2-10.1016/j.conctc.2018.100315.

Project description:BackgroundSuccessful aging is often linked to individual's ability to demonstrate resilience: the maintenance or quick recovery of functional ability, well-being, and quality of life despite losses or adversity. A crucial element of resilience is behavioral adaptability, which refers to the adaptive changes in behavior in accordance with internal or external demands. Age-related degradation of executive functions can, however, lead to volition problems that compromise flexible adjustment of behavior. In contrast, the reliance on habitual control has been shown to remain relatively intact in later life and may therefore provide an expedient route to goal attainment among older adults. In the current study, we examine whether a metacognitive self-help intervention (MCSI), aimed at facilitating goal striving through the gradual automatization of efficient routines, could effectively support behavioral adaptability in favor of resilience among older adults with and without (sub-clinical) mental health problems.MethodsThis metacognitive strategy draws on principles from health and social psychology, as well as clinical psychology, and incorporates elements of established behavioral change and activation techniques from both fields. Additionally, the intervention will be tailored to personal needs and challenges, recognizing the significant diversity that exist among aging individuals.DiscussionDespite some challenges that may limit the generalizability of the results, our MCSI program offers a promising means to empower older adults with tools and strategies to take control of their goals and challenges. This can promote autonomy and independent functioning, and thereby contribute to adaptability and resilience in later life.Trial registrationPre-registered, partly retrospectively. This study was pre-registered before the major part of the data was collected, created, and realized. Only a small part of the data of some participants (comprising the baseline and other pre-intervention measures), and the full dataset of the first few participants, was collected prior to registration, but it was not accessed yet. See: https://osf.io/5b9xz.

Project description:Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future treatment plans in mental health care services, but the verification level of the current clinical scientific knowledge is insufficient. The objective of this trial is feasibility assessment of benefits and harms of the Internet-based cognitive behavioural therapy (ICBT) programme FearFighter™ versus no intervention for anxiety disorders in adults.We will conduct an investigator-initiated, feasibility randomised controlled trial. Sixty-four participants are expected to be recruited via an advertisement posted on the homepage of the Student Counselling Service in Denmark. The inclusion criterion for participation in the trial will be the presence of anxiety disorder as assessed with the Mini International Neuropsychiatric Interview. The exclusion criteria will be suicidal risk, an ongoing episode of bipolar disorder or psychosis, concurrent psychological treatment for the anxiety disorder, considered unable to attend the intervention as planned (due to vacation, work/study placement, sickness, or similar occurrences), or lack of informed consent. The intervention group will be offered nine sessions with the ICBT programme FearFighter™ and a weekly telephone contact to support compliance. The control group will receive no intervention. We define the feasibility outcomes as follows: the fraction of randomised participants out of the eligible people (the lower 95 % confidence interval (CI)???50 %); and the fraction of compliant participants (those receiving at least six out of nine sessions) in the intervention group (the lower 95 % CI???60 %). The exploratory clinical outcomes are the number of participants no longer meeting the diagnostic criteria for an anxiety disorder at the end of the trial and level of distress (Beck Anxiety Inventory, Symptom Checklist-90-R, WHO Well-Being Index, Sheehan Disability Scale); the number of severe adverse events; and the occurrence of any psychological treatment outside the trial. To prevent bias in design, and in the gathering and analysis of data throughout the trial, we will follow the SPIRIT 2013 statement which defines standard protocol items for clinical trials.Based on our findings, we will discuss the feasibility of a future randomised controlled trial examining the benefits and harms of FearFighter™ versus no intervention for anxiety disorders in adults.ClinicalTrials.gov Identifier: NCT02499055 , registered on 1 July 2015.

Project description:BackgroundLoneliness, or perceived social isolation, is prevalent in both the general population and clinical practice. Although loneliness has repeatedly been associated with mental and physical health, research on interventions that reduce loneliness effectively is still rather scarce.ObjectiveThis study aims to evaluate the efficacy of a guided and an unguided version of the same internet-based cognitive behavioral self-help program for loneliness (SOLUS-D) for adults.MethodsA total of 250 participants will be randomly assigned to 1 of 2 intervention groups (SOLUS-D with guidance or SOLUS-D without guidance) or a wait-list control group (2:2:1 allocation ratio). Adult participants experiencing high levels of loneliness will be recruited from the general population. Individuals currently experiencing at least moderately severe depressive symptoms, an ongoing severe substance use disorder, previous or current bipolar or psychotic disorder, or acute suicidality will be excluded from the trial. Assessments will take place at baseline, 5 weeks (midassessment), and 10 weeks (postassessment). The primary outcome is loneliness assessed using the 9-item University of California, Los Angeles Loneliness Scale at the posttreatment time point. Secondary outcomes include depressive symptoms, symptoms of social anxiety, satisfaction with life, social network size, and variables assessing cognitive bias and social behavior. The maintenance of potentially achieved gains will be assessed and compared at 6 and 12 months after randomization in the 2 active conditions. Potential moderators and mediators will be tested exploratorily. Data will be analyzed on an intention-to-treat basis.ResultsRecruitment and data collection started in May 2021 and are expected to be completed by 2022, with the 12-month follow-up to be completed by 2023. As of the time of submission of the manuscript, 134 participants were randomized.ConclusionsThis 3-arm randomized controlled trial will add to the existing research on the efficacy of loneliness interventions. Furthermore, it will shed light on the role of human guidance in internet-based treatments for individuals with increased levels of loneliness and the possible mechanisms of change. If SOLUS-D proves effective, it could provide a low-threshold, cost-efficient method of helping and supporting individuals with increased levels of loneliness.Trial registrationClinicalTrials.gov NCT04655196; https://clinicaltrials.gov/ct2/show/NCT04655196.International registered report identifier (irrid)DERR1-10.2196/36358.

Project description:With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up.So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.ClinicalTrials.gov: NCT01961479, 9 October 2013.

Project description:IntroductionA subgroup of parents of children previously treated for cancer report long-term psychological distress after end of treatment. However, needs for psychological support are commonly unmet and there is a lack of evidence-based treatments tailored to the specific needs of this population. An internet-administered, guided, cognitive-behavioural therapy-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer may provide a solution. The aim is to examine the feasibility and acceptability of the intervention ENGAGE and the study procedures for a future controlled trial.Methods and analysisThe study has an uncontrolled within-group design with an embedded qualitative and quantitative process evaluation. Potential participants are parents of children previously treated for cancer, living in Sweden, recruited via their child's personal identification number (via the Swedish Childhood Cancer Registry and the Swedish Tax Agency). Parents are invited randomly with information packs sent to home addresses. Further interest in participating can be registered via information on relevant websites. The study aims to recruit 50 parents who will receive the intervention ENGAGE which is designed to be delivered over a 10-week period, and comprises one introductory chapter followed by up to 10 intervention modules addressing key concerns identified for the population. Consistent with feasibility study objectives, primary outcomes relate to recruitment, attrition, data collection, study resources, intervention delivery and acceptability. Clinical outcomes (post-traumatic stress, depression, anxiety, fear of cancer recurrence, psychological inflexibility and experiential avoidance, depressed inactivity, fatigue, quality of life and self-compassion) will be measured at baseline, post-treatment (12 weeks) and 6-month follow-up.Ethics and disseminationThe Regional Ethical Review Board in Uppsala, Sweden has granted approval for the study (Dnr: 2017/527). Results will be disseminated to relevant healthcare and patient communities, in peer-reviewed and popular science journals, and at scientific and clinical conferences.Trial registration numberISRCTN57233429; Pre-results.

Dataset Information

An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial.

Publications

An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial.

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