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. 2021 Feb 24:24:100375.
doi: 10.1016/j.invent.2021.100375. eCollection 2021 Apr.

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD)

Eileen Bendig  1 , Natalie Bauereiß  1 , Claudia Buntrock  2 , Mirela Habibović  3 , David Daniel Ebert  4 , Harald Baumeister  1
Affiliations

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD)

Eileen Bendig et al. Internet Interv. .

Abstract

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms.

Methods: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time.

Results: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05).

Conclusion: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

Keywords: APOI, Attitudes towards Psychological Online Interventions Questionnaire; AQoL-8D, Inventory for the Assessment of Quality of Life; CAD, Coronary artery disease; CBT, Cognitive Behavioral Therapy; CG, waitlist control group; CSQ, Client Satisfaction Questionnaire; Cognitive behavioral therapy; Coronary artery disease; Depression; EG, intervention group; FOP-Q-SF, Fear of Progression Questionnaire; GAD-7, Generalized Anxiety Disorder 7-item Scale; HADS, Hospital Anxiety and Depression Scale; INEP, Inventory for the assessment of negative effects of psychotherapy; ITT, intention-to-treat; Internet and mobile-based intervention; PHQ-9, Patient Health Questionnaire; Psychological intervention; SMS, short message service; WIDeCAD, Web- and mobile-based Intervention for DEpression in people with CAD; iCBT, internet-based cognitive behavioral therapy.

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Conflict of interest statement

HB received consultancy fees, reimbursement of congress attendance and travel costs as well as payments for lectures from Psychotherapy and Psychiatry Associations as well as Psychotherapy Training Institutes in the context of E-Mental-Health topics. He has been the beneficiary of study support (third-party funding) from several public funding organizations. DDE possess shares in the GET.On Institute GmbH, which works to transfer research findings on Internet- and mobile-phone-based health interventions into routine care. DDE has received payments from several companies and health insurance providers for advice on the use of Internet-based interventions. He has received payments for lectures from Psychotherapy and Psychiatry Associations and has been the beneficiary of third-party funding from health insurance providers.

Figures

Fig. 1
Fig. 1
Participant flow.
See this image and copyright information in PMC

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