Coping Effectiveness Training in Patients With Chronic Heart Failure

NCT02463903 | Completed

• 1 other identifier: 20140001
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the present study is to develop, implement and evaluate a stress management program aiming to improve emotional well-being, health-related quality of life and to reduce readmission to hospital in patients with chronic heart failure (CHF). Method: A randomized controlled study design will be employed in which the intervention consists of Coping Effectiveness Training (CET), a manual-based group intervention based on a cognitive transactional theory of stress and coping. The purpose of CET is to improve skills to appraise stress, teach a number of techniques to cope with stress, and to give an opportunity to interact with other people with similar experiences of living with CHF. The control group will receive standard health care. The intervention group will receive seven weekly sessions of CET. Self-assessments of; emotional well-being, depression and anxiety, illness perception, health-related quality of life, coping strategies and social support will be performed before the intervention, directly after the intervention, six weeks, six months and one year after the intervention period as well as measuring readmission to hospital. In addition, the participants in the intervention group will fill in an anonymous written evaluation, with closed and open ended questions, directly after the intervention.

Conditions

Heart Failure

Keywords

Adaptation, Psychological; Heart Failure; Intervention Studies; Quality of Life; Hospital Readmission; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Emotional well-being (Composite measure of positive and negative affect)

  As measured by self-assessment questionnaire PANAS. Analysis will be conducted with Repeated measures ANCOVA.

  Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention

• Depression and anxiety (Composite measure)

  As measured by self-assessment questionnaire HADS. Analysis will be conducted with Repeated measures ANCOVA.

  Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention

Secondary Outcomes (1)

• Health-related quality of life (Composite measure)

  Change from baseline directly after, 6 weeks, 6 months and 1 year after intervention

Other Outcomes (1)

• Readmission to hospital

  During the entire follow-up period, mean follow-up time an average of 3 years (median) but at least 1 year. From start of the first intervention group to end of study-date.

Study Arms (2)

Coping effectiveness Training (CET)

EXPERIMENTAL

The intervention consists of Coping Effectiveness Training (CET), a manual-based group intervention based on a cognitive transactional theory of stress and coping. The purpose of CET is to improve skills to appraise stress, teach a number of techniques to cope with stress, and to give an opportunity to interact with other people with similar experiences of living with CHF. The CET program will, in this study, be modified for patients with CHF. The intervention consists of seven, 90-minute weekly sessions led by a nurse with a Masters degree in nursing science and extensive experience in heart failure care in collaboration with a professional psychologist. Each group consisted of 8 to 12 patients.

Behavioral: Coping Effectiveness Training (CET)

Control

NO INTERVENTION

The control group will receive standard health care and will not take part of the intervention.

Interventions

Coping Effectiveness Training (CET) BEHAVIORAL

The participants in the intervention group will receive a work book explaining the theme and home assignment as well as providing a brief summary of every group session. The group leader has a manual. Both work book and manual have been translated to Swedish and adjusted to patients with chronic heart failure.

Coping effectiveness Training (CET)

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with CHF hospitalized at a heart failure ward or a heart failure outpatient clinic in Stockholm County Council, Sweden, are classified in NYHA-class II-III and are aged over 18 years.

You may not qualify if:

• Cognitive dysfunction
• life threatening disease such as cancer or primary organ failure and/or severe psychiatric diagnosis such as psychosis or severe depression, and
• not being able to understand the Swedish language.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Red Cross University College: collaborator

Related Publications (8)

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

  PMID: 16731240 BACKGROUND

• Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106.

  PMID: 12813116 BACKGROUND

• Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

  PMID: 8275167 BACKGROUND

• Chesney MA, Folkman S. Psychological impact of HIV disease and implications for intervention. Psychiatr Clin North Am. 1994 Mar;17(1):163-82.

  PMID: 8190663 BACKGROUND

• Lazarus, R.S., & Folkman, S. (1984). Stress, appraisal and coping. New York: Springer Publishing Company.

  BACKGROUND

MeSH Terms

Conditions

Heart Failure; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Fredrik Saboonchi, Professor

  Swedish Red Cross University College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: June 4, 2015
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2015-06