scholarly journals Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial

10.2196/15841 ◽  
2020 ◽  
Vol 22 (4) ◽  
pp. e15841
Author(s):  
Nilofar Rajabi Majd ◽  
Anders Broström ◽  
Martin Ulander ◽  
Chung-Ying Lin ◽  
Mark D Griffiths ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Behavioral Control ◽  
Controlled Trial ◽  
Sleep Hygiene ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Perceived Behavioral Control ◽  
Care Providers ◽  
Randomized Controlled

Background Sleep hygiene is important for maintaining good sleep and reducing insomnia. Objective This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients. Methods The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time. Results Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes. Conclusions Health care providers might consider using a CBT-I app to improve sleep among insomnia patients. Trial Registration ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732

scholarly journals Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Bindu John ◽  
Sumanth Shetty Bellipady ◽  
Shrinivasa Undaru Bhat
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Sleep Duration ◽  
Controlled Trial ◽  
Sleep Hygiene ◽  
Control Group ◽  
Sleep Onset Latency ◽  
Promotion Program ◽  
Randomized Controlled ◽  
Sleep Behaviors

Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents.Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group,n=34; control group,n=24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™Present Functioning Visual Analogue Scale, were used.Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other.Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered withISRCTN13083118.

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

10.2196/24264 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24264
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic>&lt;.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Kathleen O'Connor ◽  
Alexa Bagnell ◽  
Patrick McGrath ◽  
Lori Wozney ◽  
Ashley Radomski ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Retention Rates ◽  
Control Group ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

BACKGROUND Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. OBJECTIVE This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. METHODS This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. RESULTS Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (<i>d</i>=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. CONCLUSIONS Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. CLINICALTRIAL ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

Efficacy of a transdiagnostic cognitive-behavioral intervention for eating disorder psychopathology delivered through a smartphone app: a randomized controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Jake Linardon ◽  
Adrian Shatte ◽  
John Rosato ◽  
Matthew Fuller-Tyszkiewicz
Keyword(s):  
Randomized Controlled Trial ◽  
Eating Disorder ◽  
Binge Eating ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Smartphone App ◽  
Control Group ◽  
Randomized Controlled ◽  
Post Test ◽  
Secondary Outcomes

Abstract Background Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial. Methods Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app (n = 197) or waiting list (n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress. Results Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test (d = −0.80). Significant effects were also observed for secondary outcomes (d's = −0.30 to −0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%. Conclusion Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial

10.2196/13393 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e13393 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

Background Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. Objective The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. Methods In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. Results Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). Conclusions The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. Trial Registration ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial

10.2196/13356 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e13356
Author(s):  
Kathleen O'Connor ◽  
Alexa Bagnell ◽  
Patrick McGrath ◽  
Lori Wozney ◽  
Ashley Radomski ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Retention Rates ◽  
Control Group ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

Background Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. Objective This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. Methods This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. Results Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. Conclusions Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. Trial Registration ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

BACKGROUND During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. OBJECTIVE We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. METHODS Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. RESULTS All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. CONCLUSIONS This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. CLINICALTRIAL ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24264

Sign in / Sign up

Export Citation Format

Share Document