NCT02713360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

March 9, 2016

Last Update Submit

September 10, 2019

Conditions

ICDCognitive TherapyAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Anxiety measured by HADS.

    12 months

  • Becks Anxiety Inventory (BAI)

    16 weeks and 12 months

  • Hamilton Anxiety Scale (HAM-A)

    16 weeks and 12 months

  • HeartQoL

    16 weeks and 12 months

Other Outcomes (8)

  • ICD Shock

    16 weeks and 12 months

  • Time to first schock

    16 weeks and 12 months

  • Anti tachycardia pacing (ATP)

    16 weeks and 12 months

  • +5 more other outcomes

Study Arms (2)

Cognitive therapy

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Cognitive TherapyBEHAVIORAL
Cognitive therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years
  • Have had ICD implantation
  • Speaks and understands Danish
  • Scores 8 or more in the HADS-A questionnaire
  • Gives written informed consent

You may not qualify if:

  • Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 27798030DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Selina K. Berg, PhD.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior reseacher

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 18, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

December 15, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)