Anxiety, Cognitive Therapy, ICD
Conditions
Brief summary
The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with ICD or usual care.
Detailed description
Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone. The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy. The intervention consists of three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2. Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. After each session participants are asked to fill out the HADS questionnaire. When the patient scores below the cut-off value two times in a row, sessions will end. Each patient can have a maximum of 15 sessions.
Interventions
BEHAVIORALCognitive Therapy
Sponsors
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years * Have had ICD implantation * Speaks and understands Danish * Scores 8 or more in the HADS-A questionnaire * Gives written informed consent
Exclusion criteria
* Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome is anxiety measured by HADS. | 16 weeks | HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards. Scores 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety measured by HADS. | 12 months | HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards. Scores 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. |
| Becks Anxiety Inventory (BAI) | 16 weeks and 12 months | Becks Anxiety Inventory is a brief self-reported measure of anxiety with a focus on somatic symptoms of anxiety and was developed as a measure to discriminate between anxiety and depression. Respondents indicated how much each symptom has bothered them during the past week on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely). The BAI score ranges from 0-63. |
| Hamilton Anxiety Scale (HAM-A) | 16 weeks and 12 months | Hamilton Anxiety Scale is a clinical interview rating scale of the psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) aspects of anxiety. The scale consists of 14 clinical symptoms that are rated on a 5-point Likert scale ranging from 0 (not present) to 4 (very severe). |
| HeartQoL | 16 weeks and 12 months | The questionnaire measures health-related quality of life in patients with ischemic heart disease, specifically angina, myocardial infarction or ischemic heart failure. The questionnaire consists of 14 items and provides two subscales; a 10-item physical subscale and a 4-item emotional subscale which are scored from 0 to 3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alcohol | 16 weeks and 12 months | Number of alcohol units per week. |
| ICD Shock | 16 weeks and 12 months | The number of ICD shocks will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker & ICD Register. |
| Weight | 16 weeks and 12 months | Weight in kilogram. |
| Smoking | 16 weeks and 12 months | Number of cigarettes per day. |
| Time to first schock | 16 weeks and 12 months | Time to first schock will be measured within the 16 weeks in number of days and the data will be aggregated from the Danish Pacemaker & ICD Register. |
| Anti tachycardia pacing (ATP) | 16 weeks and 12 months | The number of ATP will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker & ICD Register. |
| Sleep quality | 16 weeks and 12 months | Patients' own evaluation of sleep quality at 16 weeks and 12 months. |
| Physical activity | 16 weeks and 12 months | Patients' own evaluation of physical activity at 16 weeks and 12 months. |
Countries
Denmark
Outcome results
None listed