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BACKGROUND: Exposure to trauma is common and can have a profoundly negative impact on mental health. Interventions based on trauma-focused cognitive behavioural therapy have shown promising results to facilitate recovery. The current trial evaluated whether a novel, scalable and digital early version of the intervention, Condensed Internet-Delivered Prolonged Exposure (CIPE), is effective in reducing post-traumatic stress symptoms. METHOD: A single-site randomised controlled trial with self-referred adults (N = 102) exposed to trauma within the last 2 months. The participants were randomised to 3 weeks of CIPE or a waiting list (WL) for 7 weeks. Assessments were conducted at baseline, week 1-3 (primary endpoint), week 4-7 (secondary endpoint) and at 6-month follow-up. The primary outcome measure was PTSD Checklist for DSM-5 (PCL-5). RESULTS: The main analysis according to the intention-to-treat principle indicated statistically significant reductions in symptoms of post-traumatic stress in the CIPE group as compared to the WL group. The between-group effect size was moderate at week 3 (bootstrapped d = 0.70; 95% CI 0.33-1.06) and large at week 7 (bootstrapped d = 0.83; 95% CI 0.46-1.19). Results in the intervention group were maintained at the 6-month follow-up. No severe adverse events were found. CONCLUSIONS: CIPE is a scalable intervention that may confer early benefits on post-traumatic stress symptoms in survivors of trauma. The next step is to compare this intervention to an active control group and also investigate its effects when implemented in regular care.
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Lista de Verificación , Terapia Cognitivo-Conductual , Adulto , Humanos , Grupos Control , InternetRESUMEN
BACKGROUND: The measurement of process variables derived from cognitive behavioural theory can aid treatment development and support the clinician in following treatment progress. Self-report process measures are ideally brief, which reduces the burden on patients and facilitates the implementation of repeated measurements. AIMS: To develop 13 brief versions (3-6 items) of existing cognitive behavioural process scales for three common mental disorders: major depression, panic disorder, and social anxiety disorder. METHOD: Using data from a real-world teaching clinic offering internet-delivered cognitive behavior therapy (n=370), we drafted brief process scales and then validated these scales in later cohorts (n=293). RESULTS: In the validation data, change in the brief process scales significantly mediated change in the corresponding domain outcomes, with standardized coefficient point estimates in the range of -0.53 to -0.21. Correlations with the original process scales were substantial (r=.83-.96), internal consistency was mostly adequate (α=0.65-0.86), and change scores were moderate to large (|d|=0.51-1.18). For depression, the brief Behavioral Activation for Depression Scale-Activation subscale was especially promising. For panic disorder, the brief Agoraphobic Cognitions Questionnaire-Physical Consequences subscale was especially promising. For social anxiety disorder, the Social Cognitions Questionnaire, the Social Probability and Cost Questionnaire, and the Social Behavior Questionnaire-Avoidance and Impression Management subscales were all promising. CONCLUSIONS: Several brief process scales showed promise as measures of treatment processes in cognitive behaviour therapy. There is a need for replication and further evaluation using experimental designs, in other clinical settings, and preferably in larger samples.
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BACKGROUND: Premature ventricular contractions (PVCs) are a common cardiac condition often associated with disabling symptoms and impaired quality of life (QoL). Current treatment strategies have limited effectiveness in reducing symptoms and restoring QoL for patients with PVCs. Symptom preoccupation, involving cardiac-related fear, hypervigilance, and avoidance behavior, is associated with disability in other cardiac conditions and can be effectively targeted by cognitive behavioral therapy (CBT). OBJECTIVE: The aim of this study was to evaluate the effect of a PVC-specific CBT protocol targeting symptom preoccupation in patients with symptomatic idiopathic PVCs. METHODS: Nineteen patients diagnosed with symptomatic idiopathic PVCs and symptom preoccupation underwent PVC-specific CBT over 10 weeks. The treatment was delivered by a licensed psychologist via videoconference in conjunction with online text-based information and homework assignments. The main components of the treatment were exposure to cardiac-related symptoms and reducing cardiac-related avoidance and control behavior. Self-rated measures were collected at baseline, post treatment, and at 3- and 6-month follow-ups. The primary outcome was PVC-specific QoL at posttreatment assessment measured with a PVC-adapted version of the Atrial Fibrillation Effects on Quality of Life questionnaire. Secondary measures included symptom preoccupation measured with the Cardiac Anxiety Questionnaire. PVC burden was evaluated with 5-day continuous electrocardiogram recordings at baseline, post treatment, and 6-month follow-up. RESULTS: We observed large improvements in PVC-specific QoL (Cohen d=1.62, P<.001) and symptom preoccupation (Cohen d=1.73, P<.001) post treatment. These results were sustained at the 3- and 6-month follow-ups. PVC burden, as measured with 5-day continuous electrocardiogram, remained unchanged throughout follow-up. However, self-reported PVC symptoms were significantly lower at posttreatment assessment and at both the 3- and 6-month follow-ups. Reduction in symptom preoccupation had a statistically significant mediating effect of the intervention on PVC-specific QoL in an explorative mediation analysis. CONCLUSIONS: This uncontrolled pilot study shows preliminary promising results for PVC-specific CBT as a potentially effective treatment approach for patients with symptomatic idiopathic PVCs and symptom preoccupation. The substantial improvements in PVC-specific QoL and symptom preoccupation, along with the decreased self-reported PVC-related symptoms warrant further investigation in a larger randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05087238; https://clinicaltrials.gov/study/NCT05087238.
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ABSTRACT: Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches.
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Terapia Cognitivo-Conductual , Fibromialgia , Terapia Implosiva , Humanos , Fibromialgia/terapia , Fibromialgia/psicología , Femenino , Masculino , Persona de Mediana Edad , Terapia Cognitivo-Conductual/métodos , Adulto , Resultado del Tratamiento , Método Simple Ciego , Terapia Implosiva/métodos , Estudios de SeguimientoRESUMEN
BACKGROUND: Atrial fibrillation (AF) is often associated with troubling symptoms leading to impaired quality of life (QoL) and high health care use. Symptom preoccupation, that is, fear of cardiac-related symptoms and avoidance behavior, potentially contributes to disability in AF but is not targeted by current interventions. OBJECTIVES: We sought to evaluate the effect of online cognitive behavior therapy (AF-CBT) on QoL in patients with symptomatic paroxysmal AF. METHODS: Patients with symptomatic paroxysmal AF (n = 127) were randomly assigned to receive AF-CBT (n = 65) or standardized AF education (n = 62). Online AF-CBT lasted 10 weeks and was therapist guided. The main components were exposure to cardiac-related symptoms and reduction of AF-related avoidance behavior. Patients were evaluated at baseline, posttreatment, and at the 3-month follow-up. Primary outcome was AF-specific QoL as assessed by the Atrial Fibrillation Effect on Quality of Life summary score (range: 0-100) at the 3-month follow-up. Secondary outcomes included AF-specific health care consumption and AF burden assessed by 5-day continuous electrocardiogram recording. The AF-CBT group was followed for 12 months. RESULTS: AF-CBT led to large improvements in AF-specific QoL (Atrial Fibrillation Effect on Quality of Life summary score) by 15.0 points (95% CI: 10.1-19.8; P < 0.001). Furthermore, AF-CBT reduced health care consumption by 56% (95% CI: 22-90; P = 0.025). The AF burden remained unchanged. Results on self-assessed outcomes were sustained 12 months after treatment. CONCLUSIONS: In patients with symptomatic paroxysmal AF, online CBT led to large improvements in AF-specific QoL and reduced health care use. If these results are replicated, online CBT may constitute an important addition to AF management. (Internet-Delivered Cognitive Behavior Therapy for Atrial Fibrillation; NCT03378349).
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Fibrilación Atrial , Terapia Cognitivo-Conductual , Humanos , Fibrilación Atrial/terapia , Electrocardiografía , Calidad de VidaRESUMEN
OBJECTIVE: To evaluate the relative impact of three brief therapist-supported internet-delivered emotion regulation treatments for maladaptive anger (mindful emotion awareness [MEA], cognitive reappraisal [CR], and mindful emotion awareness + cognitive reappraisal [MEA + CR]) and to test whether baseline levels of anger pathology moderate treatment outcome. METHOD: Treatments were evaluated in a randomized controlled trial. In total, 234 participants (59% female; mean age = 41.1, SD = 11.6) with maladaptive anger were randomized to MEA (n = 78), CR (n = 77), or MEA + CR (n = 79). Self-reported primary and secondary outcomes were followed up at primary endpoint, 3 months after treatment termination (88% retention). Primary outcomes were also assessed weekly during a prolonged baseline phase (4 weeks) and an active treatment phase (4 weeks). RESULTS: At the primary endpoint, the MEA + CR was superior in terms of anger expression (d = 0.27 95% confidence interval, CI [0.03, 0.51]), aggression (d = 0.43 [0.18, 0.68]), and anger rumination (d = 0.41 [0.18, 0.63]). MEA + CR was particularly effective in reducing anger expression (d = 0.66 [0.21, 1.11]), aggression (d = 0.90 [0.42, 1.39]), and anger rumination (d = 0.80 [0.40, 1.20]) for individuals who reported high values (+1SD) of the outcomes at baseline. CONCLUSIONS: Brief therapist-supported internet-delivered MEA and CR treatments are effective interventions for maladaptive anger. Combining MEA and CR is especially effective in reducing anger expression and aggression, particularly, in individuals who report higher levels of initial anger pathology. The present study highlights the importance of emotion regulation as an important treatment target for reducing maladaptive anger. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Regulación Emocional , Humanos , Femenino , Adulto , Masculino , Ira/fisiología , Emociones , Agresión/psicología , Resultado del TratamientoRESUMEN
OBJECTIVE: LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses the adverse impacts of minority stress. However, this treatment has rarely been tested in randomized controlled trials with LGBTQ youth and never using an asynchronous online platform for broad reach. This study examined the feasibility, acceptability, preliminary efficacy, and multi-level stigma moderators of LGBTQ-affirmative internet-based CBT (ICBT). METHOD: Participants were 120 LGBTQ youth (ages 16-25; 37.5% transgender or non-binary; 75.8% assigned female at birth; 49.2% non-Latino White) living across 38 U.S. states and reporting depression and/or anxiety symptoms. Participants were randomized to receive 10 sessions of LGBTQ-affirmative ICBT or only complete 10 weekly assessments of mental and behavioral health and minority stress; all completed measures of psychological distress, depression, anxiety, suicidal thoughts, alcohol use, and HIV-transmission-risk behavior at baseline and 4 and 8 months post-baseline; 20 LGBTQ-affirmative ICBT participants completed a qualitative interview regarding intervention acceptability. RESULTS: Participants randomized to LGBTQ-affirmative ICBT completed, on average, 6.08 (SD = 3.80) sessions. Participants reported that LGBTQ-affirmative ICBT was helpful and engaging and provided suggestions for enhancing engagement. Although most outcomes decreased over time, between-group comparisons were small and non-significant. LGBTQ-affirmative ICBT was more efficacious in reducing psychological distress than assessment-only for participants in counties high in anti-LGBTQ bias (b = -1.73, p = 0.001, 95% CI [-2.75, -0.70]). Session dosage also significantly predicted reduced depression and anxiety symptoms. CONCLUSIONS: LGBTQ-affirmative ICBT represents a feasible and acceptable treatment. Future research can identify more efficacious approaches and modalities for engaging LGBTQ youth, especially those living under stigmatizing conditions, who might benefit most.
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Terapia Cognitivo-Conductual , Minorías Sexuales y de Género , Recién Nacido , Humanos , Femenino , Adolescente , Salud Mental , Trastornos de Ansiedad/terapia , Internet , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Exposure to trauma is common and may have detrimental psychological consequences. Brief exposure therapy provided early after trauma has shown encouraging results in promoting recovery. To scale up treatment availability, we developed a 3-week internet-delivered intervention comprised of four modules based on prolonged exposure (condensed internet-delivered prolonged exposure; CIPE) with therapist support. In this pilot study, we assessed the feasibility, acceptability, and preliminary efficacy of CIPE delivered within 2 months after the index event. Thirty-three participants were randomised to CIPE or a waiting list (WL). The frequency, vividness and distress of intrusive recollections or flashback memories of the traumatic event were assessed using an intrusive memory smartphone app. Symptoms of post-traumatic stress were assessed by the PTSD Symptom Checklist for DSM-5 (PCL-5). The most common index traumas in the sample were rape, interpersonal violence and life-threatening accidents. A majority of participants (82%) randomised to CIPE completed all modules, and the number of logins per participant to the Internet platform was high during the three-week intervention (M = 19.6, SD = 11.8). At post-treatment, the CIPE participants had a more favourable reduction than the WL group on the vividness and distress ratings, as well as on the PCL-5 sum score (bootstrapped d = 0.85; 95% CI [0.25-1.45]). Treatment effects were sustained at 6-months follow up and no severe adverse events associated with the intervention were found. CIPE seems to be a feasible and possibly efficacious early intervention after trauma. Large-scale trials are needed to assess its efficacy and long-term benefits.
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Background: The use of remotely delivered early intervention after trauma may prevent and/or reduce symptoms of post-traumatic stress. Our research group evaluated a novel three-week therapist-guided internet-delivered intervention based on prolonged exposure (Condensed Internet-Delivered Prolonged Exposure; CIPE) in a pilot trial. The results indicated that the intervention was feasible, acceptable and reduced symptoms of post-traumatic stress at post-intervention compared to a waiting-list condition. Exposure to traumatic memories can be emotionally demanding and there is a need for detailed investigation of participants' experiences in receiving this type of intervention remotely. Objective: Investigate participants' experiences of receiving CIPE early after trauma. Method: In this study, qualitative thematic analysis was used and semi-structured interviews with 11 participants six months after intervention completion were conducted. All interviews were audio-recorded and transcribed verbatim. Results: One overarching theme labelled as 'demanding and effective' was identified. Participants expressed that treatment effects could only be achieved by putting in a lot of effort and by being emotionally close to the trauma memory during exposure exercises. Participants reported CIPE to be a highly credible- and educative intervention that motivated them to fully engage in exposure exercises. The most distressing parts of the intervention was perceived as tolerable and important to do to heal psychologically after trauma. For many participants, the possibility to engage in the intervention whenever and where it suited them was helpful, although some participants described it as challenging to find a balance between their own responsibility and when to expect therapist support. The internet-based format was perceived as a safe forum for self-disclosure that helped some participants overcome avoidance due to shame during imaginal exposure. Conclusion: CIPE was considered demanding, yet effective by the interviewed participants. The most distressing parts of the intervention was perceived to be the most important and were tolerable and feasible to provide online.
Antecedentes: El uso de una intervención temprana administrada a distancia después de un trauma puede prevenir y/o reducir los síntomas de estrés postraumático. Nuestro grupo de investigación evaluó una nueva intervención de tres semanas entregada por internet y guiada por un terapeuta, basada en exposición prolongada (Exposición prolongada condensada por Internet; CIPE por sus siglas en inglés) en un ensayo piloto. Los resultados indicaron que la intervención fue factible, aceptable y redujo los síntomas de estrés postraumático en la postintervención en comparación con una condición de lista de espera. La exposición a recuerdos traumáticos puede ser emocionalmente exigente y es necesario realizar una investigación detallada de las experiencias de los participantes al recibir este tipo de intervención de forma remota.Objetivo: Investigar las experiencias de los participantes al recibir CIPE en forma temprana después del trauma.Método: En este estudio se utilizó un análisis temático cualitativo y se realizaron entrevistas semiestructuradas con 11 participantes seis meses después de finalizada la intervención. Todas las entrevistas fueron grabadas en audio y transcritas textualmente.Resultados: Se identificó un tema general etiquetado como 'exigente y eficaz'. Los participantes expresaron que los efectos del tratamiento solo se pueden lograr haciendo un gran esfuerzo y estando cerca emocionalmente del recuerdo del trauma durante los ejercicios de exposición. Los participantes informaron que CIPE era una intervención educativa y de gran credibilidad que los motivó a participar plenamente en los ejercicios de exposición. Las partes más angustiantes de la intervención se percibieron como tolerables e importantes para sanar psicológicamente después del trauma. Para muchos participantes, la posibilidad de participar en la intervención cuando y donde les convenía fue útil, aunque algunos participantes describieron como desafiante el encontrar un equilibrio entre su propia responsabilidad y cuándo esperar el apoyo del terapeuta. El formato basado en Internet se percibió como un foro seguro para la autorrevelación que ayudó a algunos participantes a superar la evitación debida a la vergüenza durante la exposición imaginaria.Conclusión: CIPE fue considerada exigente, pero eficaz por los participantes entrevistados. Las partes más angustiantes de la intervención fueron percibidas como las más importantes y fueron tolerables y factibles de proporcionar en línea.
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There is an established relationship between anxiety and asthma, which is associated with poor health outcomes. Most previous cognitive behavior therapies (CBT) have focused on comorbid panic disorder whereas anxiety related to asthma may rather be illness-specific. The feasibility of an online CBT targeting avoidance behavior in anxiety related to asthma was evaluated, using a pretest-posttest design. Thirty participants with self-reported anxiety related to asthma were offered an eight-week treatment with therapist support. Mean adherence was good (80% of content), and most participants (89%) reported adequate relief after treatment. Catastrophizing about asthma (CAS), assessed at 2 months after treatment, improved significantly with a large effect size (Cohen's d = 1.52). All secondary outcomes, including asthma control, avoidance behavior, fear of asthma symptoms and quality of life, improved significantly with moderate to large effect sizes (d: 0.40-1.44). All improvements were stable at 4 months follow up. Weekly ratings showed that a decrease in avoidance behavior predicted a decrease in CAS the following week throughout the treatment period. We conclude that CBT targeting avoidance behavior is a feasible treatment for anxiety related to asthma. The results justify investigation of efficacy and mechanisms of change in a randomized controlled trial. ClinicalTrials.gov, ID: NCT03486756.
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BACKGROUND: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the adult population. AF is associated with a poor quality of life (QoL) and, in many patients, current medical treatments are inadequate in alleviating AF symptoms (eg, palpitations). Patients often present with symptom preoccupation in terms of symptom fear, avoidance, and control behaviors. Internet-delivered cognitive behavior therapy is effective for treating other somatic disorders but has never been evaluated in patients with AF. OBJECTIVE: The aim of this study is to evaluate the efficacy and feasibility of AF-specific internet-delivered cognitive behavior therapy. METHODS: We conducted an uncontrolled pilot study in which 19 patients with symptomatic paroxysmal AF underwent internet-delivered cognitive behavior therapy. Participants completed self-assessments at pretreatment, posttreatment, and at a 6-month follow-up along with handheld electrocardiogram measurements with symptom registration. The treatment lasted 10 weeks and included exposure to physical sensations, reduction in avoidance behavior, and behavioral activation. RESULTS: We observed large within-group improvements in the primary outcome, AF-specific QoL (Cohen d=0.80; P<.001), and in symptom preoccupation (Cohen d=1.24; P<.001) at posttreatment; the results were maintained at the 6-month follow-up. Treatment satisfaction and adherence rates were also high. We observed an increased AF burden, measured by electrocardiogram, at the 6-month follow-up, but a significant decrease was observed in the overestimation of AF symptoms at posttreatment and 6-month follow-up. Exploratory mediation analysis showed that a reduction in symptom preoccupation mediated the effects of internet-delivered cognitive behavior therapy on AF-specific QoL. CONCLUSIONS: This study presents preliminary evidence for the potential efficacy and feasibility of a novel approach in treating patients with symptomatic AF with internet-delivered cognitive behavior therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02694276; https://clinicaltrials.gov/ct2/show/NCT02694276.
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Functional abdominal pain (FAP) and functional dyspepsia (FD) are common in adolescents and associated with low quality of life. Exposure-based cognitive-behavioral therapy (CBT) is efficient for adult and adolescent irritable bowel syndrome (IBS), but has never been evaluated for adolescent FAP/FD. The aim of this study was to evaluate the feasibility and potential efficacy of a novel disorder-specific Internet-delivered CBT (Internet-CBT) for adolescents with FAP or FD, using an uncontrolled open pilot including 31 adolescents. The Internet-CBT consisted of 10 weekly online modules, which focused mainly on exposure to abdominal symptoms. Parents received modules to help them reduce unhelpful parental behaviors. Participants reported the treatment to be credible, and an overall satisfaction with the treatment. Data attrition rate was low (7%) and adherence to treatment was acceptable. We saw a significant and large effect on the primary outcome, pain intensity, at posttreatment (d = 1.20, p < .001) that was further improved after 6 months (d = 1.69, p < .001). Participants also made significant and large improvements on gastrointestinal symptoms (d = 0.84, p < .001) and quality of life (d = 0.84, p < .001) that were sustained or further improved at follow-up 6 months after treatment. This study demonstrated that exposure-based Internet-CBT, tailored for adolescents with FAP or FD, is a feasible treatment that potentially improves pain intensity, gastrointestinal symptoms, and quality of life.
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Dolor Abdominal/terapia , Conducta del Adolescente , Terapia Cognitivo-Conductual/métodos , Dispepsia/terapia , Terapia Implosiva/métodos , Internet , Dolor Abdominal/diagnóstico , Dolor Abdominal/psicología , Adolescente , Conducta del Adolescente/psicología , Adulto , Dispepsia/diagnóstico , Dispepsia/psicología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Padres/psicología , Calidad de Vida/psicología , Resultado del TratamientoRESUMEN
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Patients often experience a range of symptoms resulting in a markedly reduced quality of life, and commonly show symptom preoccupation in terms of avoidance and control behaviors. Cognitive behavior therapy (CBT) has been shown to improve symptom burden and quality of life in other somatic disorders, but has never been evaluated in patients with AF. The purpose of this study was to evaluate the potential efficacy and feasibility of an AF-specific CBT protocol in an uncontrolled pilot study. The study included 19 patients with symptomatic paroxysmal (intermittent) atrial fibrillation who were assessed pre- and posttreatment and at 6-month follow-up. The CBT lasted 10 weeks and included exposure to physical sensations similar to AF symptoms, exposure to avoided situations or activities, and behavioral activation. We observed large within-group improvements on the primary outcome AF-specific quality of life measurement AFEQT posttreatment (Cohen's d = 1.54; p < . 001) and at 6-month follow-up (d = 1.15; p < . 001). We also observed improvements in self-reported frequency and severity of AF symptoms. All participants completed the treatment and treatment satisfaction was high. This study demonstrates the potential efficacy and feasibility of a novel CBT approach to reduce symptoms and increase quality of life in AF patients.