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

Not Applicable

Completed

• Conditions: ICD; Cognitive Therapy; Anxiety
• Interventions: Behavioral: Cognitive Therapy

• Registration Number: NCT02713360
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Study Start: 2016-05
• Primary Completion: 2018-05
• Study Completion: 2018-12-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Hellerup, Denmark