Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)

Anxiety Clinical Trial

Official title:

Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713360
• Other study ID #: Screen-ICD
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 15, 2018

Study information

• Verified date: September 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 15, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cognitive Therapy
• ICD

Intervention

Behavioral:
• Cognitive Therapy

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev and Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICD Shock	The number of ICD shocks will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker & ICD Register.	16 weeks and 12 months
Other	Time to first schock	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.	16 weeks and 12 months
Other	Anti tachycardia pacing (ATP)	The number of ATP will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker & ICD Register.	16 weeks and 12 months
Other	Sleep quality	Patients' own evaluation of sleep quality at 16 weeks and 12 months.	16 weeks and 12 months
Other	Physical activity	Patients' own evaluation of physical activity at 16 weeks and 12 months.	16 weeks and 12 months
Other	Alcohol	Number of alcohol units per week.	16 weeks and 12 months
Other	Smoking	Number of cigarettes per day.	16 weeks and 12 months
Other	Weight	Weight in kilogram.	16 weeks and 12 months
Primary	Primary outcome is anxiety measured by HADS.	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.	16 weeks
Secondary	Anxiety measured by HADS.	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.	12 months
Secondary	Becks Anxiety Inventory (BAI)	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.	16 weeks and 12 months
Secondary	Hamilton Anxiety Scale (HAM-A)	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).	16 weeks and 12 months
Secondary	HeartQoL	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.	16 weeks and 12 months