scholarly journals Clinical Efficacy and Cost-Effectiveness of Imagery Rescripting Only Compared to Imagery Rescripting and Schema Therapy in Adult Patients With PTSD and Comorbid Cluster C Personality Disorder: Study Design of a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Arne van den End ◽  
Jack Dekker ◽  
Aartjan T. F. Beekman ◽  
Inga Aarts ◽  
Aishah Snoek ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcome ◽  
Cost Effectiveness ◽  
Personality Disorder ◽  
Clinical Efficacy ◽  
Controlled Trial ◽  
Schema Therapy ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Imagery Rescripting

Background: Posttraumatic stress disorder (PTSD) is a serious and relatively common mental disorder causing a high burden of suffering. Whereas evidence-based treatments are available, dropout and non-response rates remain high. PTSD and Cluster C personality disorders (avoidant, dependent or obsessive-compulsive personality disorder; CPD) are highly comorbid and there is evidence for suboptimal treatment effects in this subgroup of patients. An integrated PTSD and CPD treatment may be needed to increase treatment efficacy. However, no studies directly comparing the efficacy of regular PTSD treatment and treatment tailored to PTSD and comorbid CPD are available. Whether integrated treatment is more effective than treatment focused on PTSD alone is important, since (1) no evidence-based guideline for PTSD and comorbid CPD treatment exists, and (2) treatment approaches to CPD are costly and time consuming. Present study design describes a randomized controlled trial (RCT) directly comparing trauma focused treatment with integrated trauma focused and personality focused treatment.Methods: An RCT with two parallel groups design will be used to compare the clinical efficacy and cost-effectiveness of “standalone” imagery rescripting (n = 63) with integrated imagery rescripting and schema therapy (n = 63). This trial is part of a larger research project on PTSD and personality disorders. Predictors, mediators and outcome variables are measured at regular intervals over the course of 18 months. The main outcome is PTSD severity at 12 months. Additionally, machine-learning techniques will be used to predict treatment outcome using biopsychosocial variables.Discussion: This study protocol outlines the first RCT aimed at directly comparing the clinical efficacy and cost-effectiveness of imagery rescripting and integrated imagery rescripting and schema therapy for treatment seeking adult patients with PTSD and comorbid cluster C personality pathology. Additionally, biopsychosocial variables will be used to predict treatment outcome. As such, the trial adds to the development of an empirically informed and individualized treatment indication process.Clinical Trial registration:ClinicalTrials.gov, NCT03833531.

scholarly journals An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Thomas Gültzow ◽  
Eline Suzanne Smit ◽  
Raesita Hudales ◽  
Vera Knapen ◽  
Jany Rademakers ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Decision Aid ◽  
Development Process ◽  
Controlled Trial ◽  
Evidence Based ◽  
Smoking Abstinence ◽  
Randomized Controlled ◽  
Tailored Advice

BACKGROUND Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. OBJECTIVE We describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice. METHODS The development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness. RESULTS Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. CONCLUSIONS By making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes. CLINICALTRIAL Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21772

scholarly journals An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial

10.2196/21772 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21772
Author(s):  
Thomas Gültzow ◽  
Eline Suzanne Smit ◽  
Raesita Hudales ◽  
Vera Knapen ◽  
Jany Rademakers ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Decision Aid ◽  
Development Process ◽  
Controlled Trial ◽  
Evidence Based ◽  
Smoking Abstinence ◽  
Randomized Controlled ◽  
Tailored Advice

Background Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. Objective We describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice. Methods The development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness. Results Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. Conclusions By making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes. Trial Registration Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID) DERR1-10.2196/21772

The effect of feedback-informed cognitive behavioral therapy on treatment outcome: A randomized controlled trial.

2020 ◽  
Vol 88 (9) ◽  
pp. 818-828
Author(s):  
Pauline D. Janse ◽  
Kim de Jong ◽  
Carola Veerkamp ◽  
Maarten K. van Dijk ◽  
Giel J. M. Hutschemaekers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcome ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled
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