Online Personalized Psychological Intervention for Patients With Heart Disease and Depression or Anxiety (MY-CHOICE)

The MY-CHOICE project will assess the feasibility of a therapist-assisted eHealth intervention on patient satisfaction and dropout (barriers and facilitators), quality of life, and procedures with respect to recruitment and implementation in the CR settings. It is hypothesized that a therapist-assisted eHealth intervention that is personalized to patients' needs and preferences and that allows patients to engage in the intervention when and where they want, may reduce patients' barriers for seeking and engaging in treatment (e.g. drop-out).

Study design The MY-CHOICE intervention is a new comprehensive eHealth program for patients with IHD based on the premise of personalized medicine.

The intervention targets depression, anxiety and other common challenges met by patients with IHD attending CR that have been shown to impact on patients' quality of life, prognosis, motivation for self-care, compliance, and risk factor management.

Using a pre- post-test design, the study will examine the feasibility of (i) the intervention in 30 patients with IHD and co-morbid depression and/or anxiety referred to CR at one of the participating sites, including asking patients about the reason for drop-out at the time of drop-out, and (ii) evaluate the procedures for recruitment at the participating CR sites with respect to conducting a potential RCT and future implementation in routine care. Post intervention, investigators will ask all patients and 3-6 members of the CR team to complete a set of questions online related to identify barriers and facilitators for implementing the intervention in clinical care at a patient and organizational level.

Study population Patients will be recruited from cardiac rehabilitation centers in Denmark.

Study aims The primary aim of the study is to explore how patients experience and react to the intervention. We assess patients´ adherence, drop-out rate and treatment satisfaction.

The secondary aim is to assess the limited efficacy measured as the change in score on anxiety and depression (HADS) from baseline to 3-month follow-up.

MY-CHOICE intervention The intervention will partly be built on the principles of Cognitive Behavioral Therapy but also include core elements from several other psychological therapies like Acceptance and Commitment Therapy, Compassion Focused Therapy, existential psychology and Metacognitive Therapy. All patients will receive 4 mandatory core treatment modules for depression and anxiety. However, as the intervention is flexibly targetable to the individual patient's needs and preferences, and also designed to include and retain socially vulnerable patients and patients at risk of drop out - patients will choose the other modules and topics that they want to work with in a dialogue with the therapist. A flexible treatment is preferred, because each patient's life and symptom composition are different. The rationale is that an intervention tailored towards the specific anxiety and depression symptoms experienced by the individual patient is thought to be more effective than a one-size-fits all intervention.

There is a total of 13 optional modules, and depending on the treatment duration, patients will have time to complete 3-8 optional modules. The choice of modules can be adapted during the intervention, as patients' needs may change over time. After reading a short description of the optional modules, patients will be asked to indicate their preferred modules. When patients have expressed their preferences, they will talk to their therapist, who will help them decide between the optional modules.

Patients will work through the different modules, guided and supported by a therapist through asynchronous text messages. Motivational interviewing will be an integral part of the intervention to prevent drop-out. Treatment progress will be monitored every week by means of symptom questionnaires (CORE-10) that patients complete online via the platform. This information will be used in a dialogue between patients and therapists to steer the intervention, with adaptations made, if the expected progress is not seen. Therapists may contact patients via telephone during the intervention if needed. In addition to the 17 psychological intervention modules (4 mandatory, 13 optional), there will be 3 optional modules, focused on physical health and risk factor management (i.e. exercise, diet, and smoking). These modules will be offered to patients if they need more help after completing a psychologically focused module about lifestyle changes. The therapist can refer the patient to our Health Coach (HC) who is a trained physiotherapist educated in smoking cessation and diet. The HC will assess what kind of help the patient needs (e.g. refer the patient to existing treatment in the municipalities or the CR setting), or if the patient needs more, they can be offered to complete one or several of the health modules. Like the therapists, the HC will communicate with the patients by video call/phone, or written messages on the treatment platform.

All patients will have access to the material of the intervention so that they can revisit and reuse it on a need-to basis until 4 weeks after the last patient has completed the intervention. The eHealth intervention will be delivered by psychologists and master level students in psychology all employed at SDU and specialized in online psychology. The online platform (Minddistrict.com), is GDPR compliant and users log in using two-factor-authentication.

As part of the intervention, patients will be asked to complete the CORE-10 questionnaire every week to evaluate the patient's progress. Item 6 considers frequency of suicidal plans and is used as a continuous measurement of the suicidal risk of the patient. Any score above 0 will result in preventive actions from the therapist.

Procedure Within 2 weeks after discharge for an acute event from the hospital, patients with IHD are referred to a 12-week CR program. As part of current clinical practice, patients are screened for symptoms of depression and anxiety with the HADS or with the WHO-5 + MDI-2 and ASS-2 depending on the standard procedures of the site. Given that there is often a time lag between hospital referral of the patient to CR and the time that the patient can start the CR program, study procedures ensure that patients referred with a positive screening still have a positive screening at the time of inclusion into the study. Staff at the participating sites will obtain written informed consent prior to inclusion. Patients who consent will receive the baseline questionnaire package online, including the HADS, and will be contacted by telephone by one of the therapists after completion. If the HADS is negative the patient will be excluded and if positive the therapist will 1) seek to exclude major psychopathology including high suicidal risk and 2) assess whether the patient is likely to adhere to- and benefit from the treatment based on motivation, available time and energy, writing/reading capabilities and IT literacy. The interview is a standardized telephone interview, partly based on the psychiatric interview Schedules of Clinical Assessment in Neuropsychiatry (SCAN). If the therapist concludes the patient is not eligible based on the previous two criteria the patient will be excluded. If eligible, the patient will be offered the intervention and receive an appointment for a telephone-based start interview with the assigned therapist. In the start interview patients' individual symptoms of anxiety and depression will be mapped by the therapist, who will suggest how MY-CHOICE could be tailored to the patients' individual symptoms and psychological needs.

Measures and data collected The participating centers will search the patients´ medical records to determine whether patients are eligible to participate based on the inclusion and exclusion criteria. To document in/exclusion criteria this information (i.e., severe psychiatric disorder (borderline disorder, schizophrenia or bipolar disorder) (y/n), severe cognitive difficulties (y/n)), will be registered in the project database REDCap along with the patients´ planned rehabilitation (physical training, patient education, diet, and/or smoking cessation) and medical treatment for IHD (Percutaneous coronary intervention, Coronary artery bypass surgery and/or medication) for description of the study population. If patients sign the informed consent form, or want time to consider participation, their CPR-number, name, and telephone number will be registered in the project database, to enable the research team and the therapists to contact the patients who have consented to participate and to send a link to the electronic consent form to patients with time to consider. Further information on patients' demographic and clinical characteristics will be captured from purpose-designed questions in the questionnaire. Information on patients' use of the platform (e.g. time spent on platform, exercises completed) will be obtained from logging on the GDPR secure platform. All patients will complete the questionnaires at baseline and 3-months' follow-up to (i) indicate priorities for patients to work on, and (ii) use as outcome measures (see Table 1).

Data analyses The analyses will focus on assessing the limited efficacy, drop-out, adherence, and acceptability of the intervention. Due to the exploratory nature of the feasibility study, a formal power analysis was not conducted, and the sample size was determined pragmatically.

To evaluate limited efficacy, changes from baseline to 3 months follow-up on HADS-A and HADS-D will be analyzed, focusing on mean change scores as well as the proportion of study participants achieving a change score of at least 2-points, thus exceeding the minimal clinically important difference (MCID) of the HADS (36). Change score analyses will also be conducted for the Perceived Stress Scale (PSS) and Heart QoL to examine pre- to post-intervention differences.

Drop-out rates and loss to follow-up will be evaluated and summarized as counts and proportions. Adherence will be evaluated based on participants´ engagement with the intervention. Patient satisfaction with the eHealth intervention will be assessed using the 6-item Internet evaluation and usability questionnaire. To further examine acceptability, purpose-designed, qualitative open-ended questions evaluating the intervention will be collected at 3-month follow-up and explored using content analysis to identify key themes related to patients' experiences. Additionally, 6-10 patients will be interviewed post-intervention to add in-depth information about patients´ experiences with the intervention. Interviews will be transcribed and analyzed using Template Analysis.

Results from the quantitative measures will be presented descriptively, using means, standard deviations, ranges, frequencies, and proportions as appropriate.

The statistical analyses will be carried out using R statistical software.