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A randomized trial of online single-session interventions for adolescent depression during COVID-19.
Schleider, JL, Mullarkey, MC, Fox, KR, Dobias, ML, Shroff, A, Hart, EA, Roulston, CA
Nature human behaviour. 2022;(2):258-268
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Abstract
The COVID-19 pandemic has potentially increased the risk for adolescent depression. Even pre-pandemic, <50% of youth with depression accessed care, highlighting needs for accessible interventions. Accordingly, this randomized controlled trial (ClinicalTrials.gov: NCT04634903 ) tested online single-session interventions (SSIs) during COVID-19 in adolescents with elevated depression symptoms (N = 2,452, ages 13-16). Adolescents from all 50 US states, recruited via social media, were randomized to one of three SSIs: a behavioural activation SSI, an SSI teaching that traits are malleable and a supportive control. We tested each SSI's effects on post-intervention outcomes (hopelessness and agency) and three-month outcomes (depression, hopelessness, agency, generalized anxiety, COVID-19-related trauma and restrictive eating). Compared with the control, both active SSIs reduced three-month depressive symptoms (Cohen's d = 0.18), decreased post-intervention and three-month hopelessness (d = 0.16-0.28), increased post-intervention agency (d = 0.15-0.31) and reduced three-month restrictive eating (d = 0.12-17). Several differences between active SSIs emerged. These results confirm the utility of free-of-charge, online SSIs for high-symptom adolescents, even in the high-stress COVID-19 context.
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Follow-Up Study on the Effect of Cognitive Behaviour Therapy on Haemodialysis Adherence: A randomised controlled trial.
Valsaraj, BP, Bhat, SM, Prabhu, R, Kamath, A
Sultan Qaboos University medical journal. 2021;(1):e58-e65
Abstract
OBJECTIVES Patients with chronic kidney disease (CKD) undergoing haemodialysis often experience a myriad of psychosocial problems, resulting in poor adherence to their therapeutic regimen. This study aimed to examine the effect of cognitive behaviour therapy (CBT) on dialysis, fluid, drug and diet adherence among a previously reported sample of CKD patients undergoing haemodialysis. METHODS A randomised controlled trial was conducted between January 2013 to Febrary 2014 on a random selection of 67 CKD patients attending a tertiary multispecialty hospital in India. The experimental group (n = 33) was exposed to CBT, whereas the control group (n = 34) received non-directive counselling. A haemodialysis adherence scale was developed and used to assess adherence to the treatment regimen. The effect size was calculated using Cohen's d statistics. RESULTS At six months, mean reductions from baseline were observed in the experimental group in terms of interdialytic weight gain (-1.23 kg; effect size: 0.57), systolic blood pressure (-22.18 mmHg; effect size: 0.71) and diastolic blood pressure (-10.06 mmHg; effect size: 0.72), whereas mean increases were noted in haemoglobin (+0.75 g/dL; effect size: 0.31) and adherence to dialysis (+0.94; effect size: 0.51), fluids (+16.34; effect size: 2.30), diet (+61.19; effect size: 4.75) and drugs (+10.73; effect size: 1.3). Differences from baseline were significantly higher in the experimental group compared to the control group (P = 0.001 each). CONCLUSION These results show that CBT is more effective than non-directive counselling for improving therapeutic adherence and physiological, clinical parameters among CKD patients undergoing haemodialysis.
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Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression.
Dietrichkeit, M, Hagemann-Goebel, M, Nestoriuc, Y, Moritz, S, Jelinek, L
Scientific reports. 2021;(1):7861
Abstract
Although awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of "symptoms" and "quality". Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.
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Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial.
Nolan, RP, Ross, HJ, Farkouh, ME, Huszti, E, Chan, S, Toma, M, D'Antono, B, White, M, Thomas, S, Barr, SI, et al
Circulation. Heart failure. 2021;(1):e007073
Abstract
BACKGROUND International task force statements advocate telehealth programs to promote health-related quality of life for patients with chronic heart failure (CHF). To that end, we evaluated the efficacy and usability of an automated e-counseling program. METHODS This Canadian multi-site double-blind randomized trial assessed whether usual care plus either internet-based e-counseling (motivational and cognitive-behavioral tools for CHF self-care) or e-based conventional CHF self-care education (e-UC) improved 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS). Secondary outcomes included program engagement (total logon weeks, logons, and logon hours), total CHF self-care behaviors, diet (fruit and vegetable servings), 6-minute walk test, and 4-day step count. The association between program engagement and health-related quality of life was assessed using KCCQ-OS tertiles. RESULTS We enrolled 231 patients, median age =59.5 years, 22% female, and elevated median KCCQ-OS=83.0 (interquartile range, 68-93). KCCQ-OS increase ≥5 points was not more prevalent for e-counseling, n=29 (29.6%) versus e-UC, n=32 (34.0%), P=0.51. E-Counseling versus e-UC increased total logon weeks (P=0.02), logon hours (P=0.001), and logons (P<0.001). Only e-counseling showed a positive association between 12-month KCCQ-OS tertile and logon weeks (P=0.04) and logon hours (P=0.004). E-Counseling increased CHF self-care behavior and diet but not 6-minute walk test or 4-day step count. CONCLUSIONS The primary KCCQ-OS end point was negative for this trial. Only e-counseling showed a positive association between program engagement and 12-month KCCQ-OS tertile, and it improved CHF self-care behavior and diet. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01864369.
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Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.
Cunningham, NR, Kalomiris, A, Peugh, J, Farrell, M, Pentiuk, S, Mallon, D, Le, C, Moorman, E, Fussner, L, Dutta, RA, et al
The Journal of pediatrics. 2021;:62-70.e3
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Abstract
OBJECTIVES To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy, the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety. STUDY DESIGN Eligible patients between the ages of 9 and 14 years with functional abdominal pain disorders (n = 139) received enhanced usual care during their medical visit to a gastroenterologist. Those that failed to respond to enhanced usual care were randomized to receive either a tailored cognitive behavioral therapy (ADAPT) plus medical treatment as usual, or medical treatment as usual only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT plus medical treatment as usual vs medical treatment as usual on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored. RESULTS Based on recruitment and retention rates, stepped care was feasible. Enhanced usual care was effective for only 8% of youth. Participants randomized to ADAPT plus medical treatment as usual showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to medical treatment as usual only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain. CONCLUSIONS Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care. TRIAL REGISTRATION ClinicalTrials.gov: NCT03134950.
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Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.
Chan, JM, Van Blarigan, EL, Langlais, CS, Zhao, S, Ramsdill, JW, Daniel, K, Macaire, G, Wang, E, Paich, K, Kessler, ER, et al
Journal of medical Internet research. 2020;(12):e19238
Abstract
BACKGROUND Diet and exercise may be associated with quality of life and survival in men with prostate cancer. OBJECTIVE This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. METHODS We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. RESULTS In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. CONCLUSIONS A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. TRIAL REGISTRATION ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.
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The project REBOOT protocol: Evaluating a personalized inhibitory control training as an adjunct to cognitive behavioral therapy for bulimia nervosa and binge-eating disorder.
Manasse, SM, Lampe, EW, Gillikin, L, Payne-Reichert, A, Zhang, F, Juarascio, AS, Forman, EM
The International journal of eating disorders. 2020;(6):1007-1013
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Abstract
Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal. One potential explanation is that CBT fails to adequately target inhibitory control (i.e., the ability to withhold an automatic response), which is a key maintenance factor for binge eating. Computerized inhibitory control training (ICT) is a promising method for improving inhibitory control but is relatively untested in BN/BED. The present study will evaluate a computer-based ICT as an adjunct to CBT for BN/BED. Participants with BN (n = 30) or BED (n = 30) will be randomized to 12 weeks of either CBT + ICT or CBT + a sham training. Trainings will be completed daily for 4 weeks and weekly for 8 weeks. Primary aims include the following: (a) confirm target engagement (evaluate whether ICT improves inhibitory control), (b) test target validation (evaluate whether improvements in inhibitory control are associated with improvements in binge eating), and (c) evaluate the incremental efficacy of ICT on binge eating. Secondary aims include the following: (a) evaluate ICT feasibility and acceptability and (b) assess the moderating effects of approach tendencies on highly palatable food, dietary restraint, and diagnosis. Data will be used to shape a fully powered clinical trial designed to assess efficacy and dose-response effects of ICT for BN/BED.
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Food Addiction Is Associated with Binge Eating and Psychiatric Distress among Post-Operative Bariatric Surgery Patients and May Improve in Response to Cognitive Behavioural Therapy.
Cassin, S, Leung, S, Hawa, R, Wnuk, S, Jackson, T, Sockalingam, S
Nutrients. 2020;(10)
Abstract
The current study examined clinical correlates of food addiction among post-operative bariatric surgery patients, compared the clinical characteristics of patients with versus without food addiction, and examined whether a brief telephone-based cognitive behavioural therapy (Tele-CBT) intervention improves food addiction symptomatology among those with food addiction. Participants (N = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery, were randomized to receive either Tele-CBT or standard bariatric post-operative care, and then, repeated the measure of food addiction at 1.25 and 1.5 years following surgery. Thirteen percent of patients exceeded the cut-off for food addiction at 1 year post-surgery, and this subgroup of patients reported greater binge eating characteristics and psychiatric distress compared to patients without food addiction. Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention. These preliminary findings suggest that Tele-CBT may be helpful, at least in the short term, in improving food addiction symptomatology among some patients who do not experience remission of food addiction following bariatric surgery; however, these findings require replication in a larger sample.
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Posttraumatic Stress Disorder and Childhood Traumatic Loss: A Secondary Analysis of Symptom Severity and Treatment Outcome.
Unterhitzenberger, J, Sachser, C, Rosner, R
Journal of traumatic stress. 2020;(3):208-217
Abstract
Loss is a commonly experienced traumatic event among children. Although the experience of loss can potentially lead to posttraumatic stress symptoms (PTSS), little is known about PTSS levels after traumatic loss versus other traumatic events. We investigated data from a randomized controlled trial (RCT) on trauma-focused cognitive behavioral therapy (TF-CBT) versus a waitlist condition for children with PTSS. In a secondary analysis, we compared participants who reported traumatic loss as their index event (n = 23) to those who reported the two most frequently reported index events in the RCT: sexual abuse (SA; n = 59) and physical violence (PV; n = 55). The index event was rated according to the participants' most distressing traumatic event reported on the Clinician-Administered PTSD Scale for Children and Adolescents. Participants who experienced traumatic loss reported fewer PTSS and better general functioning than those who reported SA. A subgroup RCT (n = 19) revealed TF-CBT to be highly effective in reducing PTSS in cases of traumatic loss, d = 1.69. The effect sizes for PTSS indicated that all three trauma groups benefited from TF-CBT. In the waitlist group, PTSS symptoms improved for SA and PV, ds = 0.76 and 0.98, respectively, but not for traumatic loss, d = 0.23. These findings suggest that TF-CBT is a feasible and promising treatment for children who experience PTSS after traumatic loss. The results are limited by the post hoc quality of the analyses and lack of a measure of grief in the RCT.
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The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial.
Charalampopoulou, M, Bacopoulou, F, Syrigos, KN, Filopoulos, E, Chrousos, GP, Darviri, C
Breast (Edinburgh, Scotland). 2020;:210-218
Abstract
INTRODUCTION Breast cancer patients undergo extended treatments that affect their psychological state and quality of life. There is a lack of studies examining the effects of holistic stress management interventions (that combine stress perception, cognitive and lifestyle interventions) on mental health and biological indices (e.g. cortisol concentrations) of breast cancer patients. MATERIALS AND METHODS This pilot randomized controlled trial provided the first assessment of the effects of a novel, cognitive-based intervention, the Pythagorean Self-Awareness Intervention (PSAI), on psychological symptoms, quality of life, sleep quality and lifestyle as well as on stress-related biological measures of breast cancer patients undergoing adjuvant therapy. Standardized questionnaires were administered at baseline and 8-weeksafter the intervention to evaluate quality of life, stress, depression, and anxiety (primary outcomes). Sleep quality, lifestyle and hair cortisol concentrations were also assessed (secondary outcomes). RESULTS Forty-five breast cancer patients undergoing adjuvant therapy were randomly assigned to the PSAI group (n = 25) or the control group (n = 20).Women in the PSAI group reported significant improvements post-intervention in total Quality of Life, specific aspects of Quality of Life [Physical well-being, Social well-being, Emotional well-being, Functional well-being, Breast cancer concerns] as well as Perceived stress, depression, anxiety and stress. Improvements in secondary outcomes included increase in sleep quality, empowerment for healthy lifestyle and reduction of hair cortisol concentrations. CONCLUSIONS The PSAI was beneficial as complementary therapy in the women studied. Larger randomized controlled trials with longer follow-up are needed to ascertain these findings.