Clinical trial NCT02713360: Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)
Official title: Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICD
Cognitive Therapy
Anxiety
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2016-03-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome is anxiety measured by HADS.
timeFrame: 16 weeks
Secondary outcomes:
measure: Anxiety measured by HADS.
timeFrame: 12 months
measure: Becks Anxiety Inventory (BAI)
timeFrame: 16 weeks and 12 months
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: 16 weeks and 12 months
measure: HeartQoL
timeFrame: 16 weeks and 12 months
Other outcomes:
measure: ICD Shock
timeFrame: 16 weeks and 12 months
measure: Time to first schock
timeFrame: 16 weeks and 12 months
measure: Anti tachycardia pacing (ATP)
timeFrame: 16 weeks and 12 months
measure: Sleep quality
timeFrame: 16 weeks and 12 months
measure: Physical activity
timeFrame: 16 weeks and 12 months
measure: Alcohol
timeFrame: 16 weeks and 12 months
measure: Smoking
timeFrame: 16 weeks and 12 months
measure: Weight
timeFrame: 16 weeks and 12 months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Selina K. Berg, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.