Effectiveness of a blended web-based intervention on return to work for sick-listed employees with common mental disorders: results of a cluster randomized controlled trial.

BACKGROUND: Common mental disorders are strongly associated with long-term sickness absence, which has negative consequences for the individual employee's quality of life and leads to substantial costs for society. It is important to focus on return to work (RTW) during treatment of sick-listed employees with common mental disorders. Factors such as self-efficacy and the intention to resume work despite having symptoms are important in the RTW process. We developed "E-health module embedded in Collaborative Occupational health care" (ECO) as a blended Web-based intervention with 2 parts: an eHealth module (Return@Work) for the employee aimed at changing cognitions of the employee regarding RTW and a decision aid via email supporting the occupational physician with advice regarding treatment and referral options based on monitoring the employee's progress during treatment. OBJECTIVE: This study evaluated the effect of a blended eHealth intervention (ECO) versus care as usual on time to RTW of sick-listed employees with common mental disorders. METHODS: The study was a 2-armed cluster randomized controlled trial. Employees sick-listed between 4 and 26 weeks with common mental disorder symptoms were recruited by their occupational health service or employer. The employees were followed up to 12 months. The primary outcome measures were time to first RTW (partial or full) and time to full RTW. Secondary outcomes were response and remission of the common mental disorder symptoms (self-assessed). RESULTS: A total of 220 employees were included: 131 participants were randomized to the ECO intervention and 89 to care as usual (CAU). The duration until first RTW differed significantly between the groups. The median duration was 77.0 (IQR 29.0-152.3) days in the CAU group and 50.0 (IQR 20.8-99.0) days in the ECO group (hazard ratio [HR] 1.390, 95% CI 1.034-1.870, P=.03). No significant difference was found for duration until full RTW. Treatment response of common mental disorder symptoms did not differ significantly between the groups, but at 9 months after baseline significantly more participants in the ECO group achieved remission than in the CAU group (OR 2.228, 95% CI 1.115-4.453, P=.02). CONCLUSIONS: The results of this study showed that in a group of sick-listed employees with common mental disorders, applying the blended eHealth ECO intervention led to faster first RTW and more remission of common mental disorder symptoms than CAU. TRIAL REGISTRATION: Netherlands Trial Register NTR2108; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2108. (Archived by WebCite at http://www.webcitation.org/6YBSnNx3P).

Treatment of severe fear of childbirth with haptotherapy: design of a multicenter randomized controlled trial.

BACKGROUND: About six percent of pregnant women suffer from severe fear of childbirth. These women are at increased risk of obstetric labour and delivery interventions and pre- and postpartum complications, e.g., preterm delivery, emergency caesarean section, caesarean section at maternal request, severe postpartum fear of childbirth and trauma anxiety. During the last decade, there is increasing clinical evidence suggesting that haptotherapy might be an effective intervention to reduce fear of childbirth in pregnant women. The present study has been designed to evaluate the effects of such intervention. METHODS/DESIGN: Included are singleton pregnant women with severe fear of childbirth, age ≥ 18 year, randomised into three arms: (1) treatment with haptotherapy, (2) internet psycho-education or (3) care as usual. The main study outcome is fear of childbirth. Measurements are taken at baseline in gestation week 20-24, directly after the intervention is completed in gestation week 36, six weeks postpartum and six months postpartum. Secondary study outcomes are distress, general anxiety, depression, somatization, social support, mother-child bonding, pregnancy and delivery complications, traumatic anxiety symptoms, duration of delivery, birth weight, and care satisfaction. DISCUSSION: The treatment, a standard haptotherapeutical treatment for pregnant women with severe fear of childbirth, implies teaching a combination of skills in eight one hour sessions. The internet group follows an eight-week internet course containing information about pregnancy and childbirth comparable to childbirth classes. The control group has care as usual according to the standards of the Royal Dutch Organisation of Midwives and the Dutch Organization of Obstetrics and Gynaecology. TRIAL REGISTRATION: This trial was entered in the Dutch Trial Register and registered under number NTR3339 on March 4th, 2012.

Quality of the parent-child interaction in young children with type 1 diabetes mellitus: study protocol.

BACKGROUND: In young children with type 1 diabetes mellitus (T1DM) parents have full responsibility for the diabetes-management of their child (e.g. blood glucose monitoring, and administering insulin). Behavioral tasks in childhood, such as developing autonomy, and oppositional behavior (e.g. refusing food) may interfere with the diabetes-management to achieve an optimal blood glucose control. Furthermore, higher blood glucose levels are related to more behavioral problems. So parents might need to negotiate with their child on the diabetes-management to avoid this direct negative effect. This interference, the negotiations, and the parent's responsibility for diabetes may negatively affect the quality of parent-child interaction. Nevertheless, there is little knowledge about the quality of interaction between parents and young children with T1DM, and the possible impact this may have on glycemic control and psychosocial functioning of the child. While widely used global parent-child interaction observational methods are available, there is a need for an observational tool specifically tailored to the interaction patterns of parents and children with T1DM. The main aim of this study is to construct a disease-specific observational method to assess diabetes-specific parent-child interaction. Additional aim is to explore whether the quality of parent-child interactions is associated with the glycemic control, and psychosocial functioning (resilience, behavioral problems, and quality of life). METHODS/DESIGN: First, we will examine which situations are most suitable for observing diabetes-specific interactions. Then, these situations will be video-taped in a pilot study (N = 15). Observed behaviors are described into rating scales, with each scale describing characteristics of parent-child interactional behaviors. Next, we apply the observational tool on a larger scale for further evaluation of the instrument (N = 120). The parents are asked twice (with two years in between) to fill out questionnaires about psychosocial functioning of their child with T1DM. Furthermore, glycemic control (HbA1c) will be obtained from their medical records. DISCUSSION: A disease-specific observational tool will enable the detailed assessment of the quality of diabetes-specific parent-child interactions. The availability of such a tool will facilitate future (intervention) studies that will yield more knowledge about impact of parent-child interactions on psychosocial functioning, and glycemic control of children with T1DM.