Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility study.

Background and aim: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. The planned E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study (e-SMINC) aims to evaluate the effects of an internet-based intervention, building on cognitive behavioral therapy (CBT) by comparison with treatment as usual using an RCT approach. This was a small-scale single arm study designed to test the feasibility of the RCT, addressing uncertainties regarding recruitment, data collection, and intervention delivery. Methods: Participant recruitment and screening took place before discharge from the coronary care unit at a large Swedish hospital. Eligible patients were invited to a nine-step psychologist guided, internet-based CBT intervention. The sample size was set in advance to 10 participants completing the intervention. The recruitment and flow of participants were documented and evaluated in relation to seven pre-defined progression criteria. Self-reports of anxiety (HADS-A), stress (PSS-14), cardiac anxiety (CAQ), posttraumatic stress (IES-6) and quality of life (Rand-36), collected at screening, pre-intervention and post-intervention, were analysed descriptively and by effect sizes (Cohen's d). Individual interviews targeting participant experiences were conducted. Results: Six out of seven progression criteria yielded no concerns. Out of 49 patients with a working diagnosis of MINOCA or TS, 31 were eligible for screening, 26 consented to participate, and 14 were eligible with regard to symptoms of stress and/or anxiety. Eleven completed the pre-assessment and were given access the intervention, and 9 completed the intervention. Only the number of patients screened prior to eligibility assessment was slightly lower than expected, indicating possible concerns. Self-reports of anxiety, stress, cardiac anxiety, posttraumatic stress, and quality of life all indicated symptom reduction from pre- to post-intervention, generally showing large effect sizes (d = 0.6-2.6). The general consensus among participants was that the programme was helpful and relevant, and that the personal contact with the psychologist was highly valued. Setting aside time to complete assignments was found critical. Conclusion: Conducting a full scale RCT was found feasible. Inclusion of more study sites and minor amendments to the protocol and intervention were decided to improve feasibility further. Trial registration: Clinicaltrials.govNCT04178434.

The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial.

BACKGROUND: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. METHODS: The study is a randomised controlled trial, where 90 patients with a discharge diagnosis of MINOCA or TS who also report symptoms of stress or anxiety will be randomised 2-6 weeks after their cardiac event. The treatment consists of 10 weeks of Internet-based cognitive behaviour therapy (CBT) and starts immediately after randomisation for the treatment group. The control group receives usual care. Main outcomes are symptoms of anxiety measured with the Hospital Anxiety and Depression scale, anxiety subscale, and perceived stress measured with the Perceived Stress Scale, 14-item version, 10 weeks after randomisation. Secondary measures include cardiac specific anxiety, symptoms of post-traumatic stress, quality of life, cortisol measured in hair and physiological stress responses (heart rate variability, blood pressure and saliva cortisol) during a stress procedure. Ten weeks after randomisation, the control group will also receive treatment. Long-term follow-up in the self-report measures mentioned above will be conducted 20 and 50 weeks after randomisation where the total group's development over time is followed, and the groups receiving intervention early versus late compared. DISCUSSION: At present, there are no randomised studies evaluating psychological treatment for patients with MINOCA or TS. There is an urgent need for treatment alternatives aiming at relieving stress and anxiety considering the high mental stress and anxiety levels observed in MINOCA and TS, leading to decreased quality of life. CBT aiming at reducing mental stress has been shown to be effective regarding prognosis in patients with coronary artery disease. The current protocol describes a randomised open-label controlled trial evaluating an Internet-based CBT program for reduction of stress and anxiety in patients with increased mental stress and/or anxiety with a discharge diagnosis of either MINOCA or TS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04178434 . Registered on 26 November 2019.

Self-rated stress and experience in patients with Takotsubo syndrome: a mixed methods study.

BACKGROUND: A relation to stress and stressful triggers is often, but not always, described in patients with Takotsubo syndrome. Few studies have focused on patients' self-rated stress in combination with qualitative experiences of stress in Takotsubo syndrome. AIMS: The aim of this study was to describe stress before and after the onset of Takotsubo syndrome. METHODS: Twenty patients were recruited from five major hospitals in Stockholm, Sweden between December 2014 and November 2018. A mixed methods design was used containing the validated questionnaire, perceived stress scale (PSS-14) filled in at baseline and at a 6 and 12-month follow-up, respectively. Qualitative interviews were made at the 6-month follow-up. RESULTS: Self-rated stress, measured by the perceived stress scale, showed stress levels above the cut-off value of 25, at the onset of Takotsubo syndrome (median 30.5). Stress had decreased significantly at the 12-month follow-up (median 20.5, P = 0.039) but remained high in one third of the patients. Qualitative interviews confirmed a high long-term stress and half of the patients had an acute stress trigger before the onset of Takotsubo syndrome. The qualitative interviews showed that the patients had reflected on and tried to find ways to deal with stress, but for many this was not successful. CONCLUSION: Patients with Takotsubo syndrome reported long-term stress sometimes with an acute stress trigger before the onset of Takotsubo syndrome. Stress decreased over time but remained high for a considerable number of patients. Despite reflection over stress and attempts to deal with stress many were still affected after 6 months. New treatment options are needed for patients with Takotsubo syndrome.

Nitric oxide as a marker for evaluation of treatment effect of cyclosporine A in patients with bladder pain syndrome/interstitial cystitis type 3C.

OBJECTIVE: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic inflammatory disease and to date few treatments or tools for investigating the activity of the disease are available. This study evaluated whether luminal nitric oxide (NO) could be used as a marker for evaluation of therapeutic outcome in BPS/IC type 3C treated with the immunosuppressive agent cyclosporine A (CsA). MATERIAL AND METHODS: Ten patients with BPS/IC type 3C were given CsA for 16 weeks, initially at 3 mg/kg/day, and after 12 weeks the dose was scaled down. Formation of NO was measured in the urinary bladder with a silicone catheter, and symptom and bother score related to the disease were evaluated with the Interstitial Cystitis Symptom and Problem Index, every second week. RESULTS: All patients had elevated NO levels in the bladder initially and NO levels decreased during treatment with CsA. When the dose of CsA was lowered NO formation increased and after 2 weeks without medication, the NO formation was the same as before the study began. CONCLUSIONS: The results indicate that measurement of NO is a tool for evaluating the response to anti-inflammatory treatment in patients with BPS/IC type 3C. NO could serve as a marker for assessing the activity of the inflammation.