Background Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically substantial distress. Patients with AUD frequently experience high relapse rates, and only 1 in 5 remain abstinent 12 months post treatment. Traditional face-to-face relapse prevention therapy (RPT) is a form of cognitive behavioral therapy (CBT) that examines one's situational triggers, maladaptive thought processes, self-efficacy, and motivation. However, access to this treatment is frequently limited due to its high cost, long waitlists, and inaccessibility. A web-based adaptation of RPT (e-RPT) could address these limitations by providing a more cost-effective and accessible delivery method for mental health care in this population. Objective This study protocol aims to establish the first academic e-RPT program to address AUD in the general population. The primary objective of this study is to compare the efficacy of e-RPT to face-to-face RPT in decreasing relapse rates. The secondary objective is to assess the effects of e-RPT on quality of life, self-efficacy, resilience, and depressive symptomatology. The tertiary objective is to evaluate the cost-effectiveness of e-RPT compared to face-to-face RPT. Methods Adult participants (n=60) with a confirmed diagnosis of AUD will be randomly assigned to receive 10 sessions of e-RPT or face-to-face RPT. e-RPT will consist of 10 predesigned modules and homework with asynchronous, personalized feedback from a therapist. Face-to-face RPT will comprise 10 one-hour face-to-face sessions with a therapist. The predesigned modules and the face-to-face sessions will present the same content and structure. Self-efficacy, resilience, depressive symptomatology, and alcohol consumption will be measured through various questionnaires at baseline, amid treatment, and at the end of treatment. Results Participant recruitment is expected to begin in October 2022 through targeted advertisements and physician referrals. Completed data collection and analysis are expected to conclude by October 2023. Outcome data will be assessed using linear and binomial regression (for continuous and categorical outcomes, respectively). Qualitative data will be analyzed using thematic analysis methods. Conclusions This study will be the first to examine the effectiveness of e-RPT compared to face-to-face RPT. It is posited that web-based care can present benefits in terms of accessibility and affordability compared to traditional face-to-face psychotherapy. Trial Registration ClinicalTrials.gov NCT05579210; https://clinicaltrials.gov/ct2/show/NCT05579210 International Registered Report Identifier (IRRID) PRR1-10.2196/44694
Background Bipolar disorder (BD) is a highly prevalent psychiatric condition that can significantly impact every aspect of a person’s life if left untreated. A subtype of BD, bipolar disorder type II (BD-II), is characterized by long depressive episodes and residual depression symptoms, with short-lived hypomanic episodes. Medication and psychotherapy, such as cognitive behavioral therapy (CBT), are the main treatment options for BD-II. CBT specific for BD-II involves the recognition of warning signs, potentially triggering stimuli, and the development of coping skills to increase euthymic periods and improve global functioning. However, access to in-person CBT may be limited by several barriers, including low availability, high costs, and geographical limitations. Thus, web-based adaptations of CBT (e-CBT) have become a promising solution to address these treatment barriers. Nevertheless, e-CBT for the treatment of BD-II remains understudied. Objective The proposed study aims to establish the first e-CBT program specific for the treatment of BD-II with residual depressive symptoms. The primary objective of this study will be to determine the effect of e-CBT in managing BD symptomatology. The secondary objective will be to assess the effects of this e-CBT program on quality of life and resilience. The tertiary objective will involve gathering user feedback using a posttreatment survey to support the continuous improvement and optimization of the proposed program. Methods Adult participants (N=170) with a confirmed diagnosis of BD-II experiencing residual depressive symptoms will be randomly assigned to either the e-CBT and treatment as usual (TAU; n=85) group or the TAU (n=85) control group. Participants in the control group will be able to participate in the web-based program after the first 13 weeks. The e-CBT program will consist of 13 weekly web-based modules designed following a validated CBT framework. Participants will complete module-related homework and receive asynchronous personalized feedback from a therapist. TAU will consist of standard treatment services conducted outside of this research study. Depression and manic symptoms, quality of life, and resiliency will be assessed using clinically validated symptomatology questionnaires at baseline, week 6, and week 13. Results The study received ethics approval in March 2020, and participant recruitment is expected to begin in February 2023 through targeted advertisements and physician referrals. Data collection and analysis are expected to conclude by December 2024. Linear and binomial regression (continuous and categorical outcomes, respectively) will be conducted along with qualitative interpretive methods. Conclusions The findings will be the first on the effectiveness of delivering e-CBT for patients with BD-II with residual depressive symptoms. This approach can provide an innovative method to address barriers to in-person psychotherapy by increasing accessibility and decreasing costs. Trial Registration ClinicalTrials.gov NCT04664257; https://clinicaltrials.gov/ct2/show/NCT04664257 International Registered Report Identifier (IRRID) PRR1-10.2196/46157
BACKGROUND Bipolar disorder (BD) is a highly prevalent psychiatric condition that can significantly impact every aspect of a person’s life if left untreated. A subtype of BD, Bipolar disorder II (BD-II) is characterized by long depressive episodes and residual depression symptoms, with short-lived hypomanic episodes. Medication and psychotherapy, such as cognitive behavioral therapy (CBT), are the main treatment options for BD-II. CBT specific for BD-II involves the recognition of warning signs, potentially triggering stimuli, and the development of coping skills to increase euthymic periods and improve global functioning. However, access to in-person CBT may be limited by several barriers including low availability, high costs and geographical limitations. Thus, online adaptations of CBT (e-CBT) have become a promising solution to address these treatment barriers Nevertheless, e-CBT for the treatment of BD-II remains understudied. OBJECTIVE The proposed study aims to establish the first e-CBT program specific for the treatment of BD-II with residual depressive symptoms. The primary objective of this study will be to determine the effect of e-CBT in managing BD symptomatology. The secondary objective will be to assess the effects of this e-CBT program on quality of life, and resilience. The tertiary objective will involve gathering user feedback using a post-treatment survey to support the continuous improvement and optimization of the proposed program. METHODS Adult participants (n = 170) with a confirmed diagnosis of BD-II experiencing residual depressive symptoms will be randomly assigned to either the e-CBT plus TAU (n = 85) group or the TAU (n = 85) control group. Participants in the control group will be able to participate in the online program after the first 13 weeks. The e-CBT program will consist of 13 weekly online modules designed following a validated CBT framework. Participants will complete module-related homework and receive asynchronous personalized feedback from a therapist. TAU will consist of standard treatment services conducted outside of the current research study. Depression and manic symptoms quality of life and resiliency will be assessed using clinically validated symptomatology questionnaires at baseline, week 6, and week 13. RESULTS The study received ethics approval in March 2020 and participant recruitment is expected to begin in February 2023 through targeted advertisements and physician referrals. Data collection and analysis are expected to conclude by December 2024. Linear and binomial regression (continuous and categorical outcomes respectively) will be conducted along with qualitative interpretive methods. CONCLUSIONS The findings will be the first on the effectiveness of delivering e-CBT for patients with BD-II with residual depressive symptoms. This approach can provide an innovative method to address barriers to in-person psychotherapy by increasing accessibility and decreasing costs. CLINICALTRIAL clinicaltrials.gov (NCT04664257); clinicaltrials.gov/ct2/show/NCT04664257
BACKGROUND Alcohol use disorder (AUD) is characterized by problematic alcohol use accompanied by clinically significant distress. Patients with AUD frequently experience high relapse rates and only one in five remain abstinent 12 months post-treatment. Traditional face-to-face relapse prevention treatment (RPT) is a form of cognitive behavioural therapy that examines one's situational triggers, maladaptive thought processes, self-efficacy, and motivation. However, access to this treatment is frequently limited due to its high cost, long waitlists, and inaccessibility. An online adaptation of RPT (e-RPT) could address these limitations by providing a more cost-effective and accessible delivery method for mental health care in this population. OBJECTIVE This study protocol aims to establish the first academic e-RPT program to address AUD in the general population. The primary objective of this study is to compare the efficacy of e-RPT to face-to-face RPT at decreasing relapse rates. The secondary objective is to assess the effects of e-RPT on quality of life, self-efficacy, resilience, and depressive symptomatology. The tertiary objective is to evaluate cost-effectiveness of e-RPT compared to face-to-face RPT. METHODS Adult participants (n = 60) with a confirmed diagnosis of AUD will be randomly assigned to receive ten sessions of e-RPT or face-to-face RPT. e-RPT will consist of 10 predesigned modules and homework with asynchronous personalized feedback from a therapist. Face-to-face RPT will comprise 10 one-hour face-to-face sessions with a therapist. The predesigned modules and the face-to-face sessions will present the same content and structure. Self-efficacy, resilience, depressive symptomatology, and alcohol consumption will be measured through various questionnaires at baseline, mid-treatment, and end of treatment. RESULTS Participant recruitment is expected to begin in October 2022 through targeted advertisements and physician referrals. Completed data collection and analysis are expected to conclude by October 2023. Outcome data will be assessed using linear and binomial regression (continuous and categorical outcomes respectively). Qualitative data will be analyzed using thematic analysis methods. CONCLUSIONS The current study will be the first to examine the effectiveness of e-RPT compared to face-to-face RPT. It is posited that online care can present benefits in terms of accessibility and affordability compared to traditional face-to-face psychotherapy. CLINICALTRIAL clinicaltrials.gov (NCT05579210)
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