NCT01681771

Brief Summary

The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

August 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

August 30, 2012

Results QC Date

October 25, 2017

Last Update Submit

February 28, 2019

Conditions

Heart FailureDepressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms

    Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score \>10 indicate at least moderate depression.

    9 weeks

Study Arms (2)

Cogntive behaviour therapy

EXPERIMENTAL

Internet based Cognitive behaviour therapy during 9 weeks

Behavioral: Cognitive behaviour therapy

Discussion group

ACTIVE COMPARATOR

Internet moderated discussion group during 9 weeks

Behavioral: Cognitive behaviour therapyBehavioral: Discussion group

Interventions

Cognitive behaviour therapyBEHAVIORAL

Internet based, weekly home task and weekly feedback provided by health care professional.

Cogntive behaviour therapyDiscussion group
Discussion groupBEHAVIORAL

Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.

Discussion group

Eligibility Criteria

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

You may qualify if:

  • \> 18 years
  • have time to participate in the study,
  • treatment for HF according to the European Society of Cardiology guidelines2
  • stable HF (NYHA class I-III) and not being hospitalized for HF the latest month
  • signs of suffering of depressive symptoms (Patient Health Questionnaire-9 \>9 points

You may not qualify if:

  • severe HF (NYHA IV) or another severe chronic life threatening disease.
  • severe depression assessed to need hospital care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of Cardiology, University Hospital of Linköping

Linköping, 581 85, Sweden

Location

Related Publications (1)

  • Lundgren JG, Dahlstrom O, Andersson G, Jaarsma T, Karner Kohler A, Johansson P. The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Aug 3;18(8):e194. doi: 10.2196/jmir.5556.

    PMID: 27489077DERIVED

MeSH Terms

Conditions

Heart FailureDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Prof. RN Peter Johansson
Organization
Linköping University, Department of social and welfare studies. Linköping University
peter.b.johansson@liu.se
+4613313685

Study Officials

  • Peter Johansson, Assoc. Prof

    Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, Assoc. Prof

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 10, 2012

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)