Objectives/Introduction: Internet‐based cognitive behavioural therapy for insomnia (ICBTi) is a frequently used intervention. Published studies are promising, but methodological limitations (e.g., heterogeneity, low number of participants, unclear adherence to the intervention) have been reported. The aim was to describe methodological challenges perceived in the Hit‐IT study, an ongoing ICBTi study for patients with insomnia and cardiovascular disease (CVD).

The Hit‐IT study: Design: RCT with 1‐year follow‐up. All patients with CVD (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 6 primary care centers are screened for insomnia and during a clinical examination diagnosed according to DSM‐V criteria.Intervention: 9 weeks I‐CBTi (1‐week introduction, 2 weeks psychoeducation on CVD/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet‐based sleep hygiene education.Questionnnaires: Sleep (Pittsburg Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive‐ and cardiac symptoms (Patient Health Qurestionnaire‐9, Cardiac Anxiety Questionnaire) and Quality of Life (SF‐12) at baseline, during and after intervention (after 6 and 12 months).

Methods: Interim analysis with descriptive statistics.

Results: Out of 2170 approached patients with diagnosed CVD1508 (70%) responded (No=1330/Yes=178). Of the 178 approvals (124 men/54 women), 54 did not complete internet‐based screening (no e‐mail, declined participation and for unknown reasons). Of the 124 participants who completed screening, 40 (34 men/6 women, age range 42‐84 years) were excluded (ISI < 8). In addition, 32 were excluded after telephone contact and clinical examination (declined participation n = 10, no clinical insomnia n = 14, sleep apnea n = 4,restless legs n = 2, epilepsy n = 1, pharmacological side effect n = 1). Currently 46 participants have been randomized in the Hit‐IT study (15 females, 31 males, mean age 71 years/Range 41‐92 years). 19 participants have completed control group (1 dropout related to technical problems, 3 in treatment). In the intervention group, 6 have completed, 4 intentions to treat, 3 dropouts (n = 2 unknown reason, n = 1 technical problems), 10 participants in treatment.

Conclusions: Clear methodological challenges with regard to the strenuous patient inclusion process are identified. The current study has a higher mean age and higher number of participating men than current ICBTi studies in general population.

Disclosure: Nothing to disclose.