Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial.
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SUBMITTER: Thesen T
PROVIDER: S-EPMC8822426 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial.
Thesen Terje T Thesen Terje T Himle Joseph A JA Martinsen Egil W EW Walseth Liv T LT Thorup Frode F Gallefoss Frode F Jonsbu Egil E
Journal of medical Internet research 20220124 1
<h4>Background</h4>Noncardiac chest pain has a high prevalence and is associated with reduced quality of life, anxiety, avoidance of physical activity, and high societal costs. There is a lack of an effective, low-cost, easy to distribute intervention to assist patients with noncardiac chest pain.<h4>Objective</h4>In this study, we aimed to investigate the effectiveness of internet-based cognitive behavioral therapy with telephone support for noncardiac chest pain.<h4>Methods</h4>We conducted a ...[more]
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Project description:BackgroundPatients with recurrent episodes of noncardiac chest pain (NCCP) experience cardiac anxiety as they misinterpret the pain to be cardiac related and avoid physical activity that they think could threaten their lives. Psychological interventions, such as internet-delivered cognitive behavioral therapy (iCBT), targeting anxiety can be a feasible solution by supporting patients to learn how to perceive and handle their chest pain.ObjectiveThis study aims to evaluate the effects of a nurse-led iCBT program on cardiac anxiety and other patient-reported outcomes in patients with NCCP.MethodsPatients with at least two health care consultations because of NCCP during the past 6 months, and who were experiencing cardiac anxiety (Cardiac Anxiety Questionnaire score ≥24), were randomized into 5 weeks of iCBT (n=54) or psychoeducation (n=55). Patients were aged 54 (SD 17) years versus 57 (SD 16) years and were mainly women (32/54, 59% vs 35/55, 64%). The iCBT program comprised psychoeducation, mindfulness, and exposure to physical activity, with weekly homework assignments. The primary outcome was cardiac anxiety. The secondary outcomes were fear of bodily sensations, depressive symptoms, health-related quality of life, and chest pain frequency. Intention-to-treat analysis was applied, and the patients were followed up for 3 months. Mixed model analysis was used to determine between-group differences in primary and secondary outcomes.ResultsNo significant differences were found between the iCBT and psychoeducation groups regarding cardiac anxiety or any of the secondary outcomes in terms of the interaction effect of time and group over the 3-month follow-up. iCBT demonstrated a small effect size on cardiac anxiety (Cohen d=0.31). In the iCBT group, 36% (16/44) of patients reported a positive reliable change score (≥11 points on the Cardiac Anxiety Questionnaire), and thus an improvement in cardiac anxiety, compared with 27% of (13/48) patients in the psychoeducation group. Within-group analysis showed further significant improvement in cardiac anxiety (P=.04) at the 3-month follow-up compared with the 5-week follow-up in the iCBT group but not in the psychoeducation group.ConclusionsiCBT was not superior to psychoeducation in decreasing cardiac anxiety in patients with NCCP. However, iCBT tends to have better long-term effects on psychological distress, including cardiac anxiety, health-related quality of life, and NCCP frequency than psychoeducation. The effects need to be followed up to draw more reliable conclusions.Trial registrationClinicalTrials.gov NCT03336112; https://www.clinicaltrials.gov/ct2/show/NCT03336112.
| S-EPMC8838599 | biostudies-literature
Project description:BackgroundTherapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficient in the treatment of depression. However, the optimal mode and intensity of therapist support remain to be identified. Scheduled telephone support (STS) may improve adherence and outcomes but, as it is time- and resource-consuming, should be reserved for patients for whom the usual support may be insufficient.ObjectiveThis paper aims to reveal whether add-on STS for patients at risk of dropping out improves treatment adherence and symptoms in iCBT for depression.MethodsAmong patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT), those demonstrating a ≥14-day delay in initiation of treatment received invitations to this subsidiary STS study. A total of 100 consenting patients were randomly allocated to either HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention group, n=50). Proportions of those reaching midtreatment and treatment end point served as the primary outcome; secondary outcomes were change in Beck Depression Inventory (BDI)-measured depressive symptoms and time spent in treatment.ResultsAdd-on STS raised the proportion of patients reaching midtreatment compared with HUS-iCBT as usual (29/50, 58% vs 18/50, 36%; P=.045) and treatment end point (12/50, 24% vs 3/50, 6%; P=.02). Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.ConclusionsAdd-on STS enhances adherence and symptom improvement of patients at risk of dropping out of iCBT for depression in routine clinical practice.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) 55123131; http://www.isrctn.com/ISRCTN55123131.
| S-EPMC7413288 | biostudies-literature
Project description:BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial registrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.
| S-EPMC7592067 | biostudies-literature
Project description:BackgroundPatients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.ObjectiveThis randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.MethodsWe included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.ResultsResults showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.ConclusionsIn patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.Trial registrationClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.
| S-EPMC9107050 | biostudies-literature
Project description:Our aim was to compare the effects of Internet-delivered cognitive therapy (CT) and behavior therapy (BT) against a waitlist (WL) condition to better understand their unique contribution in the treatment of insomnia. Two hundred and nineteen participants with insomnia disorder were randomized to CT (n = 72), BT (n = 73), or WL (n = 74). The treatment arms consisted of 10 weekly internet-delivered modules with 15 min of telephone support per week. At pre, post, and follow-up, participants completed measures of insomnia severity, sleep diaries, functional impairment, anxiety, depression, quality of life, adverse events, satisfaction and perception of content, workload, and activity in treatment. Measures of completed exercises, modules, therapist support, and platform logins were also measured at posttreatment. Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups. Both treatment groups had significantly larger proportion of treatment remitters (CT: 35.8%, BT: 40%, WL: 2.7%) and responders (CT: 74.6%, BT 58.6%, WL: 10.8%) compared to the WL at posttreatment. There were no significant differences between the two therapy groups in terms of outcomes, except for sleep onset latency in favor of BT (6 min difference at posttreatment) and adverse events in favor of CT (CT 14.1% vs BT 43.2%). This study indicates that both Internet-delivered CT and BT are effective as stand-alone therapies for insomnia disorder. Results highlight the need for examining which therapy and subcomponents that are necessary for change. NCT02984670.
| S-EPMC7017953 | biostudies-literature
Project description:ObjectiveThe objective of this study was to evaluate the efficacy of a telephone-delivered, home-based cognitive-behavioral intervention for chronic low back pain in comparison to a matched supportive care (SC) treatment.MethodsParticipants (N=66) were patients with chronic back pain that were randomized to either an 8-week Cognitive-Behavioral Therapy (CBT) or a SC condition matched for contact frequency, format, and time. Participants completed validated measures of improvement in back pain disability, pain severity, and overall improvement.ResultsIntent-to-treat analyses at posttreatment showed that the treatment groups not show significantly different improvements in back pain disability (mean changes, -2.4 and -2.6 for CBT and SC, respectively; Cohen d, 0.49 and 0.55, respectively) or reductions in pain severity (mean changes, -0.9 and -1.4 for CBT and SC respectively; Cohen d, 0.50, and 0.90, respectively). Participants rated their overall improvement levels at 31% (CBT) versus 18.5% (SC).DiscussionResults from this clinical trial suggest that home-based, telephone-delivered CBT and SC treatments did not significantly differ in their benefits for back pain severity and disability, and may warrant further research for applications to hospital settings. Major limitations included recruitment difficulties that underpowered primary analyses, the lack of objective improvement measures, and the absence of a usual care/untreated control group for comparisons.
| S-EPMC5832497 | biostudies-literature
Project description:BackgroundOsteoarthritis-related insomnia is the most common form of comorbid insomnia among older Americans. A randomized clinical trial found that six sessions of telephone-delivered cognitive behavioral therapy for insomnia (CBT-I) improved sleep outcomes in this population. Using these data, we evaluated the incremental cost-effectiveness of CBT-I from a healthcare sector perspective.MethodsThe study was based on 325 community-dwelling older adults with insomnia and osteoarthritis pain enrolled with Kaiser Permanente of Washington State. We measured quality-adjusted life years (QALYs) using the EuroQol 5-dimension scale. Arthritis-specific quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Insomnia-specific quality of life was measured using the Insomnia Severity Index (ISI) and nights without clinical insomnia (i.e., "insomnia-free nights"). Total healthcare costs included intervention and healthcare utilization costs.ResultsOver the 12 months after randomization, CBT-I improved ISI and WOMAC by -2.6 points (95% CI: -2.9 to -2.4) and -2.6 points (95% CI: -3.4 to -1.8), respectively. The ISI improvement translated into 89 additional insomnia-free nights (95% CI: 79 to 98) over the 12 months. CBT-I did not significantly reduce total healthcare costs (-$1072 [95% CI: -$1968 to $92]). Improvements in condition-specific measures were not reflected in QALYs gained (-0.01 [95% CI: -0.01 to 0.01]); at a willingness-to-pay of $150,000 per QALY, CBT-I resulted in a positive net monetary benefit of $369 with substantial uncertainty (95% CI: -$1737 to $2270).ConclusionCBT-I improved sleep and arthritis function without increasing costs. These findings support the consideration of telephone CBT-I for treating insomnia among older adults with comorbid OA. Our findings also suggest potential limitations of the general quality of life measures in assessing interventions designed to improve sleep and arthritis outcomes.
| S-EPMC8742775 | biostudies-literature
Project description:BackgroundPatients with recurrent episodes of non-cardiac chest pain may experience cardiac anxiety and avoidance behavior, leading to increased healthcare utilization. These patients might benefit from help and support to evaluate the perception and management of their chest pain. The purpose of this study was to test the feasibility of a short guided Internet-delivered cognitive behavioural therapy (CBT) program and explore the effects on cardiac anxiety, fear of body sensations, depressive symptoms, and chest pain in patients with non-cardiac chest pain, compared with usual care.MethodsA pilot randomized controlled study was conducted. Fifteen patients with non-cardiac chest pain with cardiac anxiety or fear of body sensations, aged 22-76 years, were randomized to intervention (n = 7) or control (n = 8) groups. The four-session CBT program contained psychoeducation, physical activity, and relaxation. The control group received usual care. Data were collected before and after intervention.ResultsFive of seven patients in the intervention group completed the program, which was perceived as user-friendly with comprehensible language, adequate and varied content, and manageable homework assignments. Being guided and supported, patients were empowered and motivated to be active and complete the program. Patients in both intervention and control groups improved with regard to cardiac anxiety, fear of body sensations, and depressive symptoms, but no significant differences were found between the groups.ConclusionsThe Internet-delivered CBT program seems feasible for patients with non-cardiac chest pain, but needs to be evaluated in larger groups and with a longer follow-up period.Trial registrationClinicaltrials.gov NCT02336880 . Registered on 8 January 2015.
| S-EPMC4960843 | biostudies-literature
Project description:Pediatric functional abdominal pain disorders (FAPDs) are associated with increased health care utilization, school absences, and poor quality of life (QoL). Cost-effective and accessible interventions are needed. This multisite study tested the effects of a 3-session cognitive behavioral intervention delivered to parents, in-person or remotely, on the primary outcome of pain severity and secondary outcomes (process measures) of parental solicitousness, pain beliefs, catastrophizing, and child-reported coping. Additional outcomes hypothesized a priori and assessed included functional disability, QoL, pain behavior, school absences, health care utilization, and gastrointestinal symptoms. The study was prospective and longitudinal (baseline and 3 and 6 months' follow-up) with 3 randomized conditions: social learning and cognitive behavioral therapy in-person (SLCBT) or by phone (SLCBT-R) and education and support condition by phone (ES-R). Participants were children aged 7 to 12 years with FAPD and their parents (N = 316 dyads). Although no significant treatment effect for pain severity was found, the SLCBT groups showed significantly greater improvements compared with controls on process measures of parental solicitousness, pain beliefs, and catastrophizing, and additional outcomes of parent-reported functional disability, pain behaviors, child health care visits for abdominal pain, and (remote condition only) QoL and missed school days. No effects were found for parent and child-reported gastrointestinal symptoms, or child-reported QoL or coping. These findings suggest that for children with FAPD, a brief phone SLCBT for parents can be similarly effective as in-person SLCBT in changing parent responses and improving outcomes, if not reported pain and symptom report, compared with a control condition.
| S-EPMC5370191 | biostudies-literature
Project description:To evaluate the cost-effectiveness of Internet-based cognitive-behavioral therapy for bulimia nervosa (CBT-BN) compared to face-to-face delivery of CBT-BN. This study is a planned secondary analysis of data from a randomized clinical trial. Participants were 179 adults (98% female, mean age = 28 years) meeting DSM-IV criteria for bulimia nervosa who were randomized to group face-to-face or group Internet-based CBT-BN for 16 sessions during 20 weeks. The cost-effectiveness analysis was conducted from a third-party payor perspective, and a partial societal perspective analysis was conducted to investigate cost-utility (ie, cost per gain in quality-adjusted life-years) and patient out-of-pocket travel-related costs. Net health care costs were calculated from protocol and nonprotocol health care services using third-party payor cost estimates. The primary outcome measure in the clinical trial was abstinence from binge eating and purging, and the trial start and end dates were 2008 and 2016. The mean cost per abstinent patient at posttreatment was $7,757 (95% confidence limit [CL], $4,515, $13,361) for face-to-face and $11,870 (95% CL, $6,486, $22,188) for Internet-based CBT-BN, and at 1-year follow-up was $16,777 (95% CL, $10,298, $27,042) for face-to-face and $14,561 (95% CL, $10,165, $21,028) for Internet-based CBT-BN. There were no statistically significant differences between treatment arms in cost-effectiveness or cost-utility at posttreatment or 1-year follow-up. Out-of-pocket patient costs were significantly higher for face-to-face (mean [95% CL] = $178 [$127, $140]) than Internet-based ($50 [$50, $50]) therapy. Third-party payor cost-effectiveness of Internet-based CBT-BN is comparable with that of an accepted standard. Internet-based dissemination of CBT-BN may be a viable alternative for patients geographically distant from specialist eating disorder services who have an unmet need for treatment. ClinicalTrials.gov identifier: NCT00877786.
| S-EPMC5837958 | biostudies-literature