The Effectiveness of Internet-Based Cognitive Behavioural Therapy with Telephone Support for Non-Cardiac Chest Pain: a Randomized Controlled Trial (Preprint)

BACKGROUND Non-cardiac chest pain (NCCP) is highly prevalent and 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 NCCP patients. OBJECTIVE This study aimed to investigate the effectiveness of internet-based cognitive behavioural therapy (I-CBT) with telephone support for non-cardiac chest pain (NCCP). METHODS A randomized controlled trial comparing I-CBT to a treatment-as-usual (TAU) control condition with 12-month follow-up was conducted at a cardiac department. A total of 162 participants aged 18-70 with a diagnosis of NCCP were randomized to I-CBT (n=81) or TAU (n=81). The participants in the experimental condition received six weekly sessions of I-CBT. The sessions covered different topics related to coping with NCCP (education about the heart, physical activity, interpretations/attention, physical reactions to stress, optional panic treatment, maintaining change). Between sessions, the participants also engaged in individually tailored physical exercises with increasing intensity. In addition to the I-CBT sessions, participants received a brief weekly call from a clinician to provide support, encourage adherence and to provide access to the next session. Participants in the TAU group received standard care for their NCCP without any restrictions. Primary outcomes were cardiac anxiety measured by the Cardiac Anxiety Questionnaire (CAQ) and fear of bodily sensations measured by the Body Sensations Questionnaire (BSQ). Secondary outcomes were depression measured using the Patient Health Questionnaire (PHQ-9), health related quality of life measured using EuroQol Visual Analogue Scale (EQ-VAS) and level of physical activity assessed by an investigator-developed self-report question. Additionally, a subgroup analysis of participants with depressive symptoms at baseline (PHQ-9 ≥5) was conducted. Linear mixed models were used to evaluate treatment effects. Cohen’s d were used to calculate effect sizes. RESULTS In the main intention-to-treat analysis at the 12-month follow-up time point, participants in the I-CBT group had significant improvements in CAQ (-3.4 points, 95% CI -5.7 to -1.1; P=.004, d=0.38) and a non-significant improvement in BSQ (-2.7 points, 95% CI -5.6 to 0.3; P=.073) compared with TAU. EQ-VAS at the 12-month follow-up improved with statistical and clinical significance in the I-CBT group (8.8 points, 95% CI 2.8 to 14.8; P=.004, d=0.48) compared with TAU. Physical activity was significantly (P<.001) increased during the intervention period for the I-CBT group. Depression was significantly improved at post-treatment and 3-month follow-up, but not at 12-month follow-up. Participants with depressive symptoms at baseline seemed to have increased effect of the intervention on CAQ (d=0.55) and EQ-VAS (d=0.71) at the 12-month follow-up. In the I-CBT group 84 % (n=68) completed at least five of the six sessions. CONCLUSIONS This study provides evidence that I-CBT with minimal therapist contact and focus on physical activity is effective in reducing cardiac anxiety and increasing health related quality of life in patients with NCCP. CLINICALTRIAL ClinicalTrials.gov ID: NTC03096925