Skip to main content
OpenTrials
Completed

NCT Number: NCT02713360

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ICD Anxiety Anxiety Disorders Cognitive Therapy Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive therapy

Behavioral

Primary outcomes

  1. Primary outcome is anxiety measured by HADS.

    Time frame: 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 outcomes

  1. Anxiety measured by HADS.

    Time frame: 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.

  2. Becks Anxiety Inventory (BAI)

    Time frame: 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.

  3. Hamilton Anxiety Scale (HAM-A)

    Time frame: 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).

  4. HeartQoL

    Time frame: 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 outcomes

  1. ICD Shock

    Time frame: 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.

  2. Time to first schock

    Time frame: 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.

  3. Anti tachycardia pacing (ATP)

    Time frame: 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.

  4. Sleep quality

    Time frame: 16 weeks and 12 months

    Patients' own evaluation of sleep quality at 16 weeks and 12 months.

  5. Physical activity

    Time frame: 16 weeks and 12 months

    Patients' own evaluation of physical activity at 16 weeks and 12 months.

  6. Alcohol

    Time frame: 16 weeks and 12 months

    Number of alcohol units per week.

  7. Smoking

    Time frame: 16 weeks and 12 months

    Number of cigarettes per day.

  8. Weight

    Time frame: 16 weeks and 12 months

    Weight in kilogram.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.