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Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:Infertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting period following embryo transfer, which couples say is the most stressful period during treatment. However, at this specific phase, psychosocial counselling is not always available on the spot. The aim of this randomised controlled trial (RCT) study was to test the Positive Adjustment Coping Intervention (PACI), a low-dose, smartphone-supported psychological intervention for women and men undergoing fertility treatment. METHODS AND ANALYSIS:The effectiveness of PACI is tested by means of a prospective two-arm RCT. During the 14-day waiting period between oocyte puncture/oocyte thawing and pregnancy test, participants are randomly assigned to one of the two groups, and both women and men receive daily text messages on their smartphones. One group receives text messages with statements reflecting positive-adjustment coping attitudes, the other group messages containing cognitive distractions. The primary outcome of this study is the reduction of psychosocial burden during the waiting period of reproductive treatment. Furthermore, we want to assess whether there are differences between the interventions in a pre-post assessment. The secondary outcomes are information on perceived effectiveness and practicability of the intervention one?month after the waiting period. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Ethics Committee of Heidelberg University Faculty of Medicine (S-074/2017). Study findings are planned for dissemination via peer-reviewed journal articles and at national and international conferences. TRIAL REGISTRATION NUMBER:NCT03118219; Pre-results. PROTOCOL VERSION:Version 2.0 dated 18/02/2019.

SUBMITTER: Schick M

PROVIDER: S-EPMC6629398 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol.

Schick Maren M Roesner Sabine S Germeyer Ariane A Moessner Markus M Bauer Stephanie S Ditzen Beate B Wischmann Tewes T

BMJ open 20190709 7

<h4>Introduction</h4>Infertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting period following embryo transfer, which couples say is the most stressful period during treatment. However, at this specific phase, psychosocial counselling is not always available on the spot. The aim of this randomised controlled trial (RCT) study was to test the Positive Adj ...[more]

PMID: 31289056

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Project description:PurposeCouples as dyads suffer from the diagnosis of infertility and related treatment. These couples commonly experience emotional and physical pain and tension in their marital lives. The purpose of this study is to report on the process of developing a potentially feasible and effective complex intervention for couples undergoing in vitro fertilization treatment in China.MethodsThe Medical Research Council (MRC) framework for developing and evaluating the complex intervention was adopted to guide the development of the Partnership and Coping Enhancement Programme (PCEP). In developing the PCEP, three steps were taken, namely, (1) identifying evidence by conducting literature reviews, a concept analysis and a qualitative study; (2) identifying/developing a theory-in this case, a preliminary Endurance with Partnership Conceptual Framework (P-EPCF) was proposed; and (3) modelling the process and outcomes of the PCEP.ResultsThe PCEP that was developed is targeted mainly at the domains of the partnership mediators of stress in the P-EPCF. It consists of two sections-partnership and coping-and will be delivered to infertile couples on the day of embryo transfer. The main focuses of the programme are to facilitate mutual sharing and support in infertile couples, and to improve their individual and dyadic coping strategies while undergoing IVF treatment, especially in the period when they are waiting for the results of a pregnancy test and after the disclosure of a negative treatment outcome. The programme is couple-based, consisting of experience sharing, psychoeducation, meditation exercise, skill practise and supplemental written materials.ConclusionsThe Partnership and Coping Enhancement Programme (PCEP) for couples undergoing in vitro fertilization treatment was developed according to the guideline of the MRC framework. It is recommended that a pilot study be conducted to evaluate its feasibility and to model the process and outcomes of the programme.

Project description:To investigate the effects of a multimodal couple-based sexual health intervention for premenopausal women treated for breast cancer and their partners to provide personalised psychosexual care, and to understand participants' experience of, and adherence to, the intervention. This is an assessor-blinded, randomised controlled trial. Premenopausal women treated for breast cancer (N = 160) and their partners will be recruited. Dyads will be randomised into an intervention (n = 80) or attention control (n = 80) group. The intervention group will receive the multimodal couple-based sexual health intervention over eight weeks. The intervention comprises five face-to-face and virtual individual couple counselling sessions combined with online reading, a chat-based discussion forum, and telephone calls. The intervention is based on level I-II evidence and a robust theoretical framework. The attention control group will receive usual care plus telephone calls comprising general greetings and reminders to complete follow-up surveys. Sexual adjustment, relationship quality and quality of life will be measured at baseline, after completion of the intervention, three months and six months post-intervention. The project will adhere to the CONSORT-EHEALTH checklist. Qualitative interviews will explore the participants' experience of, and adherence to, the intervention. This study will provide the first pragmatic evidence of the effectiveness of a multimodal couple-coping intervention to support premenopausal women and their partners to improve sexuality, relationship quality and quality of life after treatment for breast cancer. Sexual health is a neglected area in clinical practice, for patients and partners. The ever-growing population of women treated for breast cancer at younger age has created a more pressing need for the development of tailored sexual health interventions. If effective, this intervention could be incorporated into routine cancer care to provide better support and care for this patient population to enhance sexual health, intimacy and overall well-being. ISRCTN35481498; prospectively registered on 08/05/2023.

Project description:Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle.In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring.Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment.The study is registered at the Clinical Tials.gov (NCT01701011).

Project description:BackgroundThis study evaluated participant satisfaction with "Couplelinks," an online psychological intervention designed for younger couples coping with breast cancer. The program included six experiential learning exercises (plus one optional module), psychoeducational information, and support from a personal mental health professional.ObjectiveThe primary objectives were to examine participants' perceptions of: the online intervention's structure and content; the value of including a professional facilitator; and benefits and drawbacks of the program.MethodsA treatment satisfaction questionnaire comprised of Likert indices and open-ended questions pertaining to treatment satisfaction was completed by 26 patients and 27 male partners (N = 53) approximately 1-2 weeks following the intervention which occurred in the context of a randomized controlled trial. Descriptive statistics were used to summarize satisfaction ratings and generalized linear models with fixed effect for gender were used to test for differences in male-female outcomes. A thematic analysis was undertaken in order to understand, organize and summarize the qualitative textual feedback.ResultsParticipants reported an overall satisfaction rating of 4.3 out of 5 (SD = 0.54) with patient satisfaction ratings being higher than that of male partners' (p = 0.01). The majority of participants considered the facilitator's role to be necessary 4.6 (SD = 0.60), and found the program to be convenient 4.1 (SD = 0.81) despite some participants struggling to keep up with the modules. Subjective data revealed participants valued the convenience and flexibility of the online intervention and appreciated the program's involvement of both partners. Participants also reported that including a professional facilitator humanized the intervention, served as motivation to progress through the program, facilitated insight into their relationship, and was reassuring. Experiential gains noted by participants included that the program: helped couples to open channels of communication; prompted them to designate quality time for one another; evoked feelings of unity and togetherness; and inspired new insight in the relationship.ConclusionSuch feedback supports the feasibility and acceptability of the Couplelinks program while offering directions for improvement of online couple-based interventions in cancer.

Project description:IntroductionThe rising prevalence of stroke and stroke-related disability witnessed globally over the past decades may cause an overwhelming demand for rehabilitation services. This situation is of concern for low-income and middle-income countries like India where the resources for rehabilitation are often limited. Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India. It was found to be feasible and acceptable, but evidence of effectiveness is lacking. Hence, as a step forward, this study intends to evaluate clinical effectiveness of the intervention through a randomised controlled trial.MethodsThe objective of the study is to evaluate whether the 'Care for Stroke' intervention is clinically and cost-effective for the reduction of dependency in activities of daily living among stroke survivors in an Indian setting. This study is designed as a randomised controlled trial comparing people who received the intervention to those receiving standard care. The trial will be pragmatic and outcome assessor-blinded. The primary outcome for the study is dependency in daily living measured by the Modified Rankin Scale (MRS). A total of 266 adult stroke survivors who fulfil the eligibility criteria will be randomised to receive either 'Care for Stroke' intervention or standard treatment and will be followed up for 6?weeks. The main analyses will compare participants allocated to the 'Care for Stroke' intervention versus those allocated to the standard treatment group on an 'intention-to-treat' basis, irrespective of whether the participants received the treatment allocated or not. The dichotomised MRS scores (0-3 and 4-6) in both the groups will be used to calculate the effect estimates with a measure of precision (95% CI) and presented in the results of the trial.Ethics and disseminationThe Indian Institute of Public Health-Hyderabad/Public Health Foundation of India - Independent Institutional Ethics Committee and the Ethics Committee of the London School of HygieneandTropical Medicine. Dissemination will be through peer-reviewed publications.Trial registration numberClinical Trial Registry of India CTRI/2017/07/009014.

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Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol.

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Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol.

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