Here is the design of a clinical trial:

Official Title: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial

Included conditions:
- Cognitive Therapy
- Anxiety Disorders
- Heart Diseases

Study Armgroups:
- {'label': 'Intervention group - cognitive behavioral therapy', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of three parts: 1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone.The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.', 'interventionNames': ['Behavioral: Cognitive-behavioural therapy']}
- {'label': 'Usual Care group', 'type': 'NO_INTERVENTION', 'description': 'The usual care group (control group) will receive usual care which consists cardiac disease control and treatment.'}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Cognitive-behavioural therapy', 'description': 'Cognitive-behavioural therapy intervention', 'armGroupLabels': ['Intervention group - cognitive behavioral therapy']}

Primary Outcomes:
- {'measure': 'Hospital Anxiety and Depression Scale (HADS) Anxiety', 'description': 'Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.\n\nScores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.', 'timeFrame': '5 months'}

Please estimate the sample size based on the assumption: 
Significance level (type 1 error) set at 0.05 and 0.01, power set at 90%, and assumptions for secondary outcomes with SDs of 0.46 and 17.3, and power >0.999 and 0.914 respectively.
Sample size
          It has previously been found that among cardiac patients the minimal clinically important difference on the HADS is 1.7 points.44 In a trial investigating the effect of CBT on patients with implantable cardioverter defibrillator (ICD) and anxiety,45 a difference between groups of four points was found; intervention group 4.95 (SD 3.30) versus usual care group 8.98 (SD 4.03), p<0.0001, Cohenâs d â0.86. Therefore, an expected difference of 2 points seems reasonable. The SD is found to be 2.7 in a group of 3250 patients with heart disease and HADS-A above 8 (unpublished data from the DenHeart dataset).
          With a power of 90% and a type 1 error set at 0.05, a total of 39 patients should be entered into each group. If the risk of type I error is reduced to 0.01 and the expected minimal difference is still two points then 56 patients should be entered into each group. To allow for sub-analyses on each of the main groups, arrhythmia, heart failure and ischaemic heart disease, we include a total of 336 patients (168 intervention patients and 168 control patients) equally distributed among the three main diagnostic groups to have sufficient statistical power.