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

Rigshospitalet

Status: Completed

Conditions: Cognitive Therapy; Anxiety; ICD

Treatments: Behavioral: Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02713360

Screen-ICD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Cognitive therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Therapy

Usual care

No Intervention group

Description:

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.