Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease

Depression Clinical Trial

Official title:

Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778074
• Other study ID #: 2015-02600
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients. Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.

The overall purpose of this study is to evaluate the effects of the tailored I-CBT program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT program in clinical cardiac care.

The primary aim:

-To evaluate the effects of the tailored I-CBT depression program on depressive symptoms.

Secondary aims:

• To evaluate effects on quality of life´, sleep and anxiety

• To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.

• To gain knowledge about the I-CBT program, as perceived by patients and health care professionals.

• To explore facilitators and barriers to the implementation of the I-CBT program in clinical practice from the perspectives of patients, health care professionals and policymakers.

Description:

Power calculation: Effect size=0.5, alpha=0.05 (Z=1.96), Power 0.80 (Z -0.84) = 122 participants. Due to drop-outs or deaths the size of the study population for the RCT study was decided to n=140.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treatment for CVD according to European Society of Cardiology guidelines.

• stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks.

• depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) > 5 points)

Exclusion Criteria:

• severe CVD (NYHA IV) or another severe chronic life-threatening disease

• severe depression assessed as requiring acute treatment

• not being able to dedicate 3-4 hours to participate in the program

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Internet cognitive behavioural therapy
A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation.
• Moderated Discussion Forum
Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program.

Locations

Country	Name	City	State
Sweden	Linkoping University	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression	Score at 9 weeks follow-up