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

NCT02778074 | Completed Results

• 1 other identifier: 2015-02600
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease; Depression

Keywords

Internet Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Internet Cognitive Behavioural Therapy

EXPERIMENTAL

Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.

Behavioral: Internet cognitive behavioural therapy

Moderated discussion forum

PLACEBO COMPARATOR

In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.

Behavioral: Moderated Discussion Forum

Interventions

Internet cognitive behavioural therapy BEHAVIORAL

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.

Also known as: I-CBT

Internet Cognitive Behavioural Therapy

Moderated Discussion Forum BEHAVIORAL

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.

Moderated discussion forum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Linkoping University

Norrköping, 601 74, Sweden

Location

Related Publications (6)

• Mourad G, Lundgren J, Andersson G, Johansson P. Healthcare use in patients with cardiovascular disease and depressive symptoms - The impact of a nurse-led internet-delivered cognitive behavioural therapy program. A secondary analysis of a RCT. Internet Interv. 2023 Dec 5;35:100696. doi: 10.1016/j.invent.2023.100696. eCollection 2024 Mar.

  PMID: 38093803 DERIVED

• Westas M, Mourad G, Andersson G, Lundgren J, Johansson P. The effects of internet-based cognitive behaviour therapy for depression in cardiovascular disease on symptoms of anxiety: a secondary analysis of a randomized trial. Eur J Cardiovasc Nurs. 2024 May 28;23(4):382-390. doi: 10.1093/eurjcn/zvad097.

  PMID: 37740442 DERIVED

• Johansson P, Lundgren J, Andersson G, Svensson E, Mourad G. Internet-Based Cognitive Behavioral Therapy and its Association With Self-efficacy, Depressive Symptoms, and Physical Activity: Secondary Analysis of a Randomized Controlled Trial in Patients With Cardiovascular Disease. JMIR Cardio. 2022 Jun 3;6(1):e29926. doi: 10.2196/29926.

  PMID: 35657674 DERIVED

• Mourad G, Lundgren J, Andersson G, Husberg M, Johansson P. Cost-effectiveness of internet-delivered cognitive behavioural therapy in patients with cardiovascular disease and depressive symptoms: secondary analysis of an RCT. BMJ Open. 2022 Apr 11;12(4):e059939. doi: 10.1136/bmjopen-2021-059939.

  PMID: 35410939 DERIVED

• Westas M, Lundgren J, Andersson G, Mourad G, Johansson P. Effects of Internet-delivered cognitive behavioural therapy adapted for patients with cardiovascular disease and depression: a long-term follow-up of a randomized controlled trial at 6 and 12 months posttreatment. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):559-567. doi: 10.1093/eurjcn/zvab131.

  PMID: 35061868 DERIVED

• Johansson P, Westas M, Andersson G, Alehagen U, Brostrom A, Jaarsma T, Mourad G, Lundgren J. An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial. JMIR Ment Health. 2019 Oct 3;6(10):e14648. doi: 10.2196/14648.

  PMID: 31584000 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr Peter Johansson
• Organization: Linkoping University

peter.b.johansson@liu.se

0460700896548

Study Officials

• Peter Johansson, PhD

  Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden

  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: RN, PhD, Professor

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 19, 2016
• Study Start: February 6, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: December 11, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

SE (1)