scholarly journals Evaluation of an Adaptive Implementation Program for Cognitive Adaptation Training for People With Severe Mental Illness: Protocol for a Randomized Controlled Trial

10.2196/17412 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e17412
Author(s):  
Michelle Thalia van Dam ◽  
Jaap van Weeghel ◽  
Stynke Castelein ◽  
Gerdina Hendrika Maria Pijnenborg ◽  
Lisette van der Meer
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Implementation Research ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Cognitive Adaptation ◽  
Randomized Controlled ◽  
Implementation Program ◽  
Health Institutions

Background Cognitive Adaptation Training is a psychosocial intervention that focuses on reducing the negative effects of cognitive disorders, especially executive functions such as planning and targeted action. International research has shown that Cognitive Adaptation Training enhances multiple aspects of daily functioning in people with severe mental illnesses. Despite this evidence, implementation of the intervention into routine care remains a challenge. Objective In this implementation research, a newly developed implementation program based on previous experience and scientific literature, is tested. The primary aim of this research is to assess the effectiveness of the implementation program. The secondary aim of this study is to evaluate the factors that impede or facilitate the implementation of Cognitive Adaptation Training. Methods To test the effectiveness of the implementation program, a multicenter cluster randomized controlled trial was conducted comparing the implementation program to a single training program in four mental health institutions in The Netherlands. Focus groups, semistructured interviews, and questionnaires were used at multiple levels of service delivery (service user, professional, team, organization) to identify factors that may hamper or facilitate implementation. The RE-AIM framework was applied to measure the implementation effectiveness. Following this framework, the primary outcomes were Reach, Intervention Effectiveness, Adoption, Implementation, and Maintenance. These are assessed before, during, and after implementation. The research had a total duration of 14 months, with a follow-up measurement at 14 months. Data will be analyzed using multilevel modeling. Results The study was funded in April 2018. Data collection occurred between November 2018 and January 2020. In total, 21 teams of 4 mental health institutions agreed to participate. Data analysis is ongoing and results are expected to be published in December 2020. Conclusions This implementation research may provide important information about the implementation of psychosocial interventions in practice and may result in a program that is useful for Cognitive Adaptation Training, and possibly for psychosocial interventions in general. Trial Registration The Netherlands Trial Register (NL7989); https://www.trialregister.nl/trial/7989. International Registered Report Identifier (IRRID) DERR1-10.2196/17412

scholarly journals Evaluation of an Adaptive Implementation Program for Cognitive Adaptation Training for People With Severe Mental Illness: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Michelle Thalia van Dam ◽  
Jaap van Weeghel ◽  
Stynke Castelein ◽  
Gerdina Hendrika Maria Pijnenborg ◽  
Lisette van der Meer
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Implementation Research ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Cognitive Adaptation ◽  
Randomized Controlled ◽  
Implementation Program ◽  
Health Institutions

BACKGROUND Cognitive Adaptation Training is a psychosocial intervention that focuses on reducing the negative effects of cognitive disorders, especially executive functions such as planning and targeted action. International research has shown that Cognitive Adaptation Training enhances multiple aspects of daily functioning in people with severe mental illnesses. Despite this evidence, implementation of the intervention into routine care remains a challenge. OBJECTIVE In this implementation research, a newly developed implementation program based on previous experience and scientific literature, is tested. The primary aim of this research is to assess the effectiveness of the implementation program. The secondary aim of this study is to evaluate the factors that impede or facilitate the implementation of Cognitive Adaptation Training. METHODS To test the effectiveness of the implementation program, a multicenter cluster randomized controlled trial was conducted comparing the implementation program to a single training program in four mental health institutions in The Netherlands. Focus groups, semistructured interviews, and questionnaires were used at multiple levels of service delivery (service user, professional, team, organization) to identify factors that may hamper or facilitate implementation. The RE-AIM framework was applied to measure the implementation effectiveness. Following this framework, the primary outcomes were Reach, Intervention Effectiveness, Adoption, Implementation, and Maintenance. These are assessed before, during, and after implementation. The research had a total duration of 14 months, with a follow-up measurement at 14 months. Data will be analyzed using multilevel modeling. RESULTS The study was funded in April 2018. Data collection occurred between November 2018 and January 2020. In total, 21 teams of 4 mental health institutions agreed to participate. Data analysis is ongoing and results are expected to be published in December 2020. CONCLUSIONS This implementation research may provide important information about the implementation of psychosocial interventions in practice and may result in a program that is useful for Cognitive Adaptation Training, and possibly for psychosocial interventions in general. CLINICALTRIAL The Netherlands Trial Register (NL7989); https://www.trialregister.nl/trial/7989. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17412

scholarly journals Protocol of a Multi-centric Randomized Controlled Trial to Evaluate Efficacy of Telephone-Based Psychosocial Interventions on Future Suicide Risk in Suicide Attempters

2020 ◽  
Vol 42 (6_suppl) ◽  
pp. S39-S45
Author(s):  
Ram Pratap Beniwal ◽  
Priya Sreedaran ◽  
Uttara Chari ◽  
Ashok MV ◽  
Triptish Bhatia
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Treatment ◽  
Suicide Attempts ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Health Treatment ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Telephone Reminders

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck’s Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck’s Hopelessness Scale, Beck’s Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors.

scholarly journals A Randomized Controlled Trial to Assess Feasibility and Acceptability of Telephone-Based Psychosocial Interventions in Individuals Who Attempted Suicide

2020 ◽  
pp. 025371762093927
Author(s):  
Priya Sreedaran ◽  
Ram Pratap Beniwal ◽  
Uttara Chari ◽  
Smitha T S ◽  
Vidhya Shree S V ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Suicide Attempt ◽  
Attempted Suicide ◽  
Controlled Trial ◽  
Feasibility Studies ◽  
Psychosocial Interventions ◽  
Dropout Rates ◽  
Randomized Controlled ◽  
Seeking Help

Background: Brief contact interventions such as telephone-based contacts appear to be useful in individuals who attempted suicide. Most studies of telephone-based contacts in such individuals typically consisted of frequent phone reminders for adherence to treatment and seeking help for mental health issues. Telephone-based psychosocial interventions that incorporate elements of supportive and problem-solving strategies are of interest in Indian settings due to their potential application in mitigating the wide mental health gap. Feasibility studies of telephone-based psychosocial interventions could help ascertain the difficulties that arise in the implementation of such treatments. Methods: A multicentric randomized controlled trial (RCT) is currently underway in general hospital settings in two Indian cities to study the efficacy of telephone-based psychosocial interventions in individuals with a recent suicide attempt, with routine telephone contacts (TCs) serving as the comparator. Prior to that RCT, this feasibility study was conducted to assess the acceptability of the telephone-based intervention and telephone contacts. Feasibility was assessed using dropout rates. Acceptability was assessed using participant-rated Likert-based visual analog scores from 0 to 10, with higher scores indicating greater acceptability. Results: Dropout rates and mean acceptability scores for telephone-based psychosocial interventions were 38.5% and 8.63, while those for TCs were 41.7% and 7.57, respectively. Conclusions: Telephone-based psychosocial interventions are feasible and acceptable in individuals with a recent suicide attempt.

scholarly journals An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial

10.2196/14106 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e14106 ◽  
Author(s):  
Ángel C Pinto-Bruno ◽  
Anne Margriet Pot ◽  
Annet Kleiboer ◽  
Rose-Marie Droes ◽  
Annemieke van Straten
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Waiting List ◽  
Online Interventions ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
People With Dementia

Background About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. Objective This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. Methods A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). Results Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. Conclusions Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. Trial Registration Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 International Registered Report Identifier (IRRID) DERR1-10.2196/14106

scholarly journals An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Ángel C Pinto-Bruno ◽  
Anne Margriet Pot ◽  
Annet Kleiboer ◽  
Rose-Marie Droes ◽  
Annemieke van Straten
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
The Netherlands ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Waiting List ◽  
Online Interventions ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
People With Dementia

BACKGROUND About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. OBJECTIVE This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers’ mental health and coping resources. METHODS A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). RESULTS Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. CONCLUSIONS Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. CLINICALTRIAL Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14106

scholarly journals Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saratu Umar Aliyu ◽  
Shmaila M. Hanif ◽  
Isa Usman Lawal
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Pelvic Floor ◽  
Controlled Trial ◽  
Fistula Repair ◽  
Randomized Controlled ◽  
Urine Leakage ◽  
Pelvic Floor Strength

Abstract Background Post-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries. It entails continuous leakage of urine after successful VVF closure. Pelvic Floor Muscle Training (PFMT) plays a vital role in the management of PFRI, however, an evolving exercise approach is the Paula Exercise Method (PEM) which has shown a promising effect in stopping urinary incontinence, but there is no data on its effect on PFRI. This study therefore, proposes to primarily investigate the effect of PEM on urine leakage and secondarily, pelvic floor strength (PFS), quality of life (QoL), sexual function (SF), and mental health (MH) in women with PFRI. Methods This is a study protocol for a randomized controlled trial. A total of 182 participants are expected to participate in the study after satisfying the inclusion criteria. The participants will be randomized into either PEM or PFMT study groups. The demographic data of all the participants will be recorded. Each participant will be assessed for urine leakage, PFS, QoL, SF, and MH at baseline and subsequently, at four, eight and 12 weeks of intervention. Demographic parameters will be summarized using descriptive statistics. Continuous data will be computed for differences using inferential statistic of Analysis of variance, t-test and Man Whitney U as appropriate. All analyses will be performed using SPSS version 22.0 with probability set at 0.05 alpha level. Discussion It is hoped that the outcome of this study will determine the effect of the Paula exercise method on urine leakage, pelvic floor strength, quality of life, sexual function, and mental health among women with post-fistula-repair incontinence and also provide evidence for the use of the Paula method in urinary incontinence. Trial registration: Pan African Clinical Trials Registry (www.pactr.org), identifier PACTR201906515532827.

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

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