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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Cognitive Therapy; ICD
• Intervention / Treatment: Behavioral: Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Hellerup, Denmark, 2900
    • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive therapy; The intervention consists of 3 steps. 1: Consultation with a nurse that aims of identifying what the anxiety consist of and how the patient experiences his or her life situation with an ICD. A plan is made to structure the treatment. 2: Participation in an individualized intervention based on anxiety type specific protocols. 3. 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.	Behavioral: Cognitive Therapy
No Intervention: Usual care; The control group will receive usual care which consists of control of ICD, disease control and treatment, and at one of the sites an offer of a group information meeting where experiences and events with ICD are discussed. The meeting takes place at Rigshospitalet every other month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Sleep quality	Patients' own evaluation of sleep quality at 16 weeks and 12 months.	16 weeks and 12 months
Physical activity	Patients' own evaluation of physical activity at 16 weeks and 12 months.	16 weeks and 12 months
Alcohol	Number of alcohol units per week.	16 weeks and 12 months
Smoking	Number of cigarettes per day.	16 weeks and 12 months
Weight	Weight in kilogram.	16 weeks and 12 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Selina K. Berg, PhD., Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Berg SK, Herning M, Svendsen JH, Christensen AV, Thygesen LC. The Screen-ICD trial. Screening for anxiety and cognitive therapy intervention for patients with implanted cardioverter defibrillator (ICD): a randomised controlled trial protocol. BMJ Open. 2016 Oct 21;6(10):e013186. doi: 10.1136/bmjopen-2016-013186.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Screen-ICD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO