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 and power estimations
        
          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.
        
        
          Power estimations for secondary outcomes
          BAI: In a previous study, the response within each subject group was normally distributed with an SD of.46 If the true difference between the intervention and control group means is 5.245 we will be able to reject the null hypothesis that the population means of the intervention and control groups are equal with a probability (power) >0.999.
          HRV (SDNNi): In a previous study the response within each subject group was normally distributed with a SD of 17.3 (6). If the true difference in the intervention and control group means is 6.32, we will be able to reject the null hypothesis that the population means of the intervention and control groups are equal with a probability (power) of 0.914.