A randomized trial to assess the efficacy of a psychoeducational intervention on caregiver burden in schizophrenia

2016 ◽  
Vol 33 (1) ◽  
pp. 9-17 ◽  
Author(s):  
M. Martín-Carrasco ◽  
P. Fernández-Catalina ◽  
A.I. Domínguez-Panchón ◽  
M. Gonçalves-Pereira ◽  
E. González-Fraile ◽  
...  

AbstractBackgroundPatient's relatives usually care for patients with schizophrenia, and as informal caregivers they experience negative consequences. The aim of the EDUCA-III trial is to test the efficacy of a psychoeducational intervention program (PIP) versus standard care to reduce the caregiver burden at post-intervention (4 months), and at follow-up (8 months).MethodA two-arm, evaluator blind, multicentre, randomized controlled trial. The PIP group had 12 weekly group sessions. The control intervention group had the usual support and standard care. Primary outcomes were change scores since baseline on the Zarit Burden Interview (ZBI) and the Involvement Evaluation Questionnaire (IEQ).ResultsOne hundred and nine caregivers were randomized to PIP and 114 to control condition from 23 research sites. The decrease of ZBI scores was significantly higher on the PIP arm at 4 months (mean difference [MD] = −4.33; 95% CI −7.96, −0.71), and at 8 months (MD = −4.46; 95% CI −7.79, −1.13). There were no significant decreases in the IEQ scores (MD at 4 months = −2.80; 95% CI −6.27, 0.67; MD at 8 months = −2.85; 95% CI −6.51, 0.81).ConclusionsThe PIP condition seems to reduce caregiver burden.Trial registrationISRCTN32545295.

Author(s):  
Rano Zakirova-Engstrand ◽  
Lise Roll-Pettersson ◽  
Kristina Andersson ◽  
Helena Larsson ◽  
Mara Allodi Westling ◽  
...  

AbstractThis initial open feasibility trial reports on feasibility and preliminary effectiveness of the manualized, group-based psychoeducational intervention for grandparents of preschool-aged children with ASD provided by the outpatient habilitation services in Stockholm, Sweden. One hundred and twenty non-custodial grandparents participated in a 6-h intervention program. The study demonstrated good feasibility: 114 (95%) grandparents competed both pre- and post-intervention measures and evaluations and reported high intervention acceptability. The results also indicated that grandparents increased their knowledge about ASD from pre-intervention to post-intervention, gained skills about strategies of supporting their grandchildren and adult children, and appreciated the opportunity to meet and share experiences with other grandparents. Follow-up with a randomized controlled trial design is needed to firmly establish efficacy of this intervention.


2021 ◽  
Author(s):  
Kotaro Imamura ◽  
Natsu Sasaki ◽  
Yuki Sekiya ◽  
Kazuhiro Watanabe ◽  
Asuka Sakuraya ◽  
...  

BACKGROUND The prolonged coronavirus disease 2019 (COVID-19) pandemic affected mental health among workers. Psychoeducational intervention via an Internet website could be effective for primary prevention of mental health among workers in the current COVID-19 pandemic. OBJECTIVE The aim of this randomized controlled trial (RCT) was to examine the effect of a newly developed online psychoeducational website named "Imacoco-care" on reducing psychological distress and fear about COVID-19 infection among workers. METHODS Participants in the present study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Participants in the intervention group were invited to access the Imacoco-care within a month after the baseline survey. Kessler’s Psychological Distress Scale (K6) and The Fear of COVID-19 Scale (FCV-19S) were obtained at baseline, 1-, and 3-month follow-ups. RESULTS A total of 1200 workers were randomly allocated to an intervention or control group (n = 600 for each). In the intention-to-treat (ITT) analyses, the Imacoco-care showed significant favorable effect on K6 (p = 0.03) with small effect size (d = -0.14), and adverse effect on FCV-19S (p = 0.01) with small effect size (d = 0.16) in the intervention group at 3-month follow-up. In the per-protocol analyses (only included participants who have read the Imacoco-care at least one time), the Imacoco-care also showed significant favorable effect on reducing K6 (p = 0.03), while adverse effect on FCV-19S was not significant (p = 0.06) in the intervention group at 3-month follow-up. CONCLUSIONS A web-based psychoeducation approach may be effective on improving psychological distress in a general working population, while it may be important not only distributing information but also encouraging to access and see the contents to prevent the adverse effect of psychoeducational intervention. CLINICALTRIAL The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The registration number is UMIN000042556 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548).


Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.


2014 ◽  
Vol 45 (7) ◽  
pp. 1401-1412 ◽  
Author(s):  
P. Otero ◽  
F. Smit ◽  
P. Cuijpers ◽  
A. Torres ◽  
V. Blanco ◽  
...  

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.


2018 ◽  
Vol 40 (1) ◽  
pp. 333-343 ◽  
Author(s):  
Júlia Halamová ◽  
Martin Kanovský ◽  
Karolína Varšová ◽  
Nuriye Kupeli

AbstractThe Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is an intervention developed to increase skills of self-compassion and protective anger with the aim to decrease self-criticism. This novel intervention was developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and previous programs cultivating compassion (namely Compassion Mind Training and Mindful Self-Compassion Program). According to existing research, simply cultivating self-compassion is not always sufficient in reducing self-criticism. Therefore, the EFT-SCP was designed to build self-compassion whilst developing protective anger to combat self-criticism. Our goal was to investigate the efficacy of this new, short-term, online EFT-SCP program in a non-clinical population. A randomized control trial was conducted with pre- and post-intervention measurements and two-month follow-up of self-compassion and self-criticism/reassurance. Convenience sampling was used to recruit participants through a snowballing technique on social media. A total of 123 participants were randomly allocated to the EFT-SCP intervention or to a control condition. The intervention group were instructed through emails to complete an EFT-SCP task every day for 14 consecutive days. The control group did not complete any tasks. Out of 123 participants, 31 from intervention group and 20 from control group completed all measurements. There was a significant effect of the EFT-SCP on increasing self-compassion and self-reassurance scores as reported at two-month follow-up. The EFT-SCP was also effective at reducing self-uncompassionate responding and self-criticism (specifically Hated self) with changes evident at two months post-intervention. These findings are encouraging and suggest that interventions designed to enhance self-compassion and decrease self-criticism can be delivered to broader populations without the direct contact with mental health professionals.


2017 ◽  
Vol 39 (8) ◽  
pp. 1192-1212 ◽  
Author(s):  
Leigh Small ◽  
Leroy Thacker ◽  
Heather Aldrich ◽  
Darya Bonds-McClain ◽  
Bernadette Melnyk

The purpose of this pilot randomized controlled trial (RCT) was to intervene with parents of overweight/obese 4- to 8-year-old children to improve child internalizing and externalizing behaviors. Parent–child dyads ( N = 60) were randomly assigned to treatment or comparison conditions. Parents attended four intervention sessions at their child’s primary health care office over 3 months. Child behaviors were assessed at 0, 3, 6, and 12 months post intervention. Parental beliefs in their skills/abilities increased in the experimental group parents, but there was no statistical difference between groups at any time. Child externalizing behaviors significantly decreased from baseline to postintervention for both groups ( F = 3.26, p = .020). Post hoc model testing suggests that this change was more pronounced in the intervention group ( F = 0.56, p = .692). Child somatic symptoms significantly decreased over time ( F = 4.55, p = .004), and there were group differences in child depressive behaviors ( F = 6.19, p = .020). These findings suggest that a parent-focused intervention program demonstrated positive preliminary effects on children’s behaviors.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.


2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.


Author(s):  
Gesche Janzarik ◽  
Daniel Wollschläger ◽  
Michèle Wessa ◽  
Klaus Lieb

In this study, a new group intervention program to foster resilience in nursing professionals was tested for efficacy. In total, 72 nurses were recruited and randomised to either an intervention condition or to a wait list control condition. The study had a pre-test, post-test, follow-up design. The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness. Compared to the control group, the intervention group reported a significant improvement in the primary outcome mental health (measured with the General Health Questionnaire) from pre-test (M = 20.79; SD = 9.85) to post-test (M = 15.81; SD = 7.13) with an estimated medium effect size (p = 0.03, η2 = 0.08) at post-test. Further significant improvements were found for resilience and other resilience related outcomes measures. The individual stressor load of the subjects was queried retrospectively in each measurement. Stress levels had a significant influence on mental health. The intervention effect was evident even though the stress level in both groups did not change significantly between the measurements. Follow-up data suggest that the effects were sustained for up to six months after intervention. The resilience intervention reduced mental burden in nurses and also positively affected several additional psychological outcomes.


2020 ◽  
Author(s):  
Shuai Yang ◽  
Li Li ◽  
Liqian Wang ◽  
Jiaqi Zeng ◽  
Bin Yan ◽  
...  

Abstract Background: Intensive care unit (ICU) nurses are at high risk for work-related musculoskeletal disorders (WRMDs). Data on occupational injuries indicate the significance of WRMDs among ICU nurses. Intervention programs have previously been developed to reduce WRMDs, but different intervention methods need to be adopted for different groups of people. This study aimed to evaluate the effectiveness of a multidimensional intervention program to prevent and reduce WRMDs in ICU nurses.Methods: This study was designed as a two-armed cluster-controlled trial with an intervention group and a control group. The clusters were independent hospital ICUs, and the participants consisted of registered nurses in China. By cluster random sampling, 89 nurses from two ICUs were assigned to the intervention group, and 101 nurses from two other ICUs were assigned to the control group. A multidimensional intervention program based on previous studies was designed. This program combined improving risk perception, health behavior training, and promoting a safe working environment. The multidimensional intervention program was implemented in the intervention group, whereas routine specialist training was implemented in the control group. Baseline and follow-up (3 and 6 months) data were collected using self-reported online questionnaires. The primary outcome was the report rate of WRMDs in the past 7 days. Secondary outcomes were risk perception, application of health behavior, and perception of a safe working environment. The data were statistically analyzed using SPSS 19.0.Results: A total of 190 nurses provided three recorded outcome measurements (intervention group, N = 89 (94.68%); control group, N = 101 (94.39%)). After 6 months, the intervention group experienced significant improvement relative to the control group in the report rate of WRMDs in the past 7 days (OR = 1.953, p = 0.037), risk perception (OR = 0.517, p < 0.001), application of health behavior (OR = 0.025, p < 0.001), and perception of a safe working environment (OR = 1.637, p = 0.024).Conclusion: The multidimensional intervention program was superior to routine specialist training in preventing the occurrence of WRMDs in ICU nurses. WRMD training should include multifaceted approaches and pay increased attention to specific department functions.


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