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- Andersson, Peter, et al.
(författare)
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Implementation and evaluation of Illness Management and Recovery (IMR) in mandated forensic psychiatric care-Study protocol for a multicenter cluster randomized trial
- 2022
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier. - 2451-8654. ; 27
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Forensic mental health care is hampered by lack of evidence-based treatments. The Swedish forensic mental health population consists of patients suffering from severe illnesses such as schizophrenia and bipolar disorders, similar to populations in international studies. Illness Management and Recovery (IMR) is an intervention for patients with serious mental illness, based on psychoeducational, cognitive-behavioral and motivational components. The purpose is to strengthen participants' illness management skills and recovery.Objective: To test effectiveness of IMR within forensic mental health by comparing it to treatment as usual.Method: This is a cluster-randomized controlled trial. Patients in forensic mental health inpatient units are randomized to an active (IMR) or a control condition (treatment as usual). Clustering of patients is based on ward-units where inpatients are admitted. Patients in the active condition receive two group and one individual IMR sessions per week. The treatment phase is estimated to last nine months. Outcomes include illness related disability, illness management skills, sense of recovery, hope, mental health and security related problems. Outcomes are measured at baseline, four months into treatment, at treatment completion and at three months follow-up. Staff experiences of implementing IMR will be explored by a self-report measure and semi-structured interview based on Normalization Process Theory.Ethics and dissemination: The study is approved by the Swedish Ethical Review Authority (Registration No. 2020-02046). Participation will be voluntary based on written informed consent. Results will be disseminated through peer-reviewed articles and conferences. The study is registered in the US registry of clinical trials (NCT04695132).
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| 2. |
- Singh, Laura, et al.
(författare)
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A first remotely-delivered guided brief intervention to reduce intrusive memories of psychological trauma for healthcare staff working during the ongoing COVID-19 pandemic : Study protocol for a randomised controlled trial
- 2022
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 26
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Tidskriftsartikel (refereegranskat)abstract
- Addressing the mental health needs of healthcare staff exposed to psychologically traumatic events at work during the COVID-19 pandemic is a pressing global priority. We need to swiftly develop interventions to target the psychological consequences (e.g., persistent intrusive memories of trauma). Interventions for healthcare staff must be brief, flexible, fitted around the reality and demands of working life under the pandemic, and repeatable during ongoing/further trauma exposure. Intervention delivery during the pandemic should be remote to mitigate risk of infection; e.g., here using a blend of digitalized self-administered materials (e.g., video instructions) and guided (remote) support from a researcher. This parallel groups, two-arm, randomised controlled trial (RCT) with healthcare staff working during the COVID-19 pandemic is the first evaluation of whether a digitalized form of a brief cognitive task intervention, which is remotely-delivered (guided), reduces intrusive memories. Healthcare staff who experience intrusive memories of work-related traumatic event(s) during the COVID-19 pandemic (≥2 in the week before inclusion) will be randomly allocated (1:1) to receive either the cognitive task intervention or an active (attention placebo) control, and followed up at 1-week, 1-month, 3-months, and 6-months post-intervention. The primary outcome will be the number of intrusive memories reported during Week 5; secondary and other outcomes include the number of intrusive memories reported during Week 1, and other intrusive symptoms. Findings will inform further development and dissemination of a brief cognitive task intervention to target intrusive memories.
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| 3. |
- Söderström, Hanna, et al.
(författare)
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Does a gluten-free diet lead to better glycemic control in children with type 1 diabetes? : Results from a feasibility study and recommendations for future trials
- 2022
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier. - 2451-8654. ; 26
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Tidskriftsartikel (refereegranskat)abstract
- Background: Increasing evidence suggests a link between type 1 diabetes (T1D) and intake of gluten, but no controlled trials have examined whether a gluten-free diet (GFD) has positive effects on glycemic control in children with T1D. Methods: We conducted a non-randomized feasibility study. Twenty-three children with newly diagnosed T1D were included and either followed a GFD (n = 14) or a normal diet (n = 9) for 12 months. Effects of diet on glycemic control were examined by measuring insulin production (c-peptide), hemoglobine A1c (HbA1c) and insulin dose adjusted A1c (IDAA1c). Degree of adherence to the GFD and effects on quality of life were also examined. Results: Children on a GFD showed a statistically significantly lower HbA1c at six months (P = 0.042) compared with children on a normal diet and point estimate differences indicated better glycemic control in the GFD group at 6 and 12 months. Adherence to a GFD varied but was satisfactory for a majority of children. The GFD group reported poorer quality of life at inclusion and there was a non-significant difference for quality of life between groups throughout the study. Conclusions: A strict GFD can be maintained by children with newly diagnosed T1D and may have positive effects on glycemic control. Our findings should be interpreted carefully because of small samples and possible confounding. We provide recommendations for future trials and suggest using a randomized-controlled design with 30–40 participants in each arm.
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