NCT03203395

Brief Summary

Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear of physical activity and excessive worry. Patients currently receiving treatment for heart disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If such symptoms are detected, patients will be offered a counselling session with a clinical psychologist. Further, routines for collaborative communication between clinical psychologist, cardiologist and the patient's general physician will be emphasized.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable depression

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

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

June 23, 2017

Last Update Submit

December 3, 2019

Conditions

DepressionDepressive SymptomsDepressive DisorderAnxietyAnxiety DisordersPanic AttacksHeart DiseasesCollaboration

Keywords

DepressionAnxietyPanic AttacksCollaborative CareHeart disease and depressionHeart disease and anxietyHeart disease and panic attacks

Outcome Measures

Primary Outcomes (3)

  • Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.

    All patients included in the study will be screened for symptoms of depression, anxiety and recent panic attack by filling out a survey consisting of questions from the Patient Health Questionnaire-2 (PHQ-2), the Generalized Anxiety Disorder Scale-2 (GAD-2) and a question about whether they experienced a panic attack in the last four weeks. Cut-off is set to a score of ≥ 2 on PHQ-2 and/or GAD-2 and/or a positive answer on the question about panic attack.

    15 minutes

  • Detection of patients with or at risk for depression and/or anxiety disorders.

    Patients who screened positive for symptoms of depression, anxiety and/or panic attack will be asked to complete the Hospital Anxiety and Depression Scale (HADS). Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist.

    1 hour

  • Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.

    Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist aimed to treat and prevent depression and anxiety disorders in heart patients.

    1-2 hours

Study Arms (1)

Heart patients

EXPERIMENTAL

Screening and counselling

Behavioral: Screening and counselling

Interventions

Screening and counsellingBEHAVIORAL

Screening for symptoms of depression and anxiety in heart patients, giving advice for prevention and managing of such symptoms and stimulating collaborative care between the hospital and the general practitioner.

Heart patients

Eligibility Criteria

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

You may qualify if:

  • Men and women over 18 years under treatment for myocardial infarction, heart failure, tachyarrhythmia and/or valvular heart disease at the Department of Internal Medicine, Diakonhjemmet Hospital.

You may not qualify if:

  • Unable to provide informed consent.
  • Unable to read and/or understand Norwegian.
  • Unable to complete a survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionDepressive DisorderAnxiety DisordersPanic DisorderHeart Diseases

Interventions

Mass ScreeningCounseling

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticeMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health Services

Study Officials

  • Torkil Berge, Psychologist

    Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Development Counselor

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 29, 2017

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share