NCT02226575

Brief Summary

The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

August 19, 2014

Last Update Submit

March 5, 2015

Conditions

Atrial Fibrillation

Keywords

Sense of coherence

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52.

    baseline and after 12 months

  • Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52

    baseline and after 12 mounth

  • Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52

    baseline and after 12 months

Secondary Outcomes (1)

  • Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52

    baseline and after 12 months

Study Arms (2)

Distress management

EXPERIMENTAL

The distress management program (cognitive behavioral therapy) alongside standard care

Behavioral: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives

Control

NO INTERVENTION

Controls only dilivery standard care

Interventions

A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relativesBEHAVIORAL

Controls only delivery standard care. Experimental group deliver standard care plus a distress management program (cognitive behavioral therapy) performed in groups by a nurse, a pedagogue and a cardiologist (all trained in the distress management program).

Distress management

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with atrial fibrillation.
  • Relative to patient with atrial fibrillation.
  • To be over 18 years old .

You may not qualify if:

  • Unwillingness to participate in the study.
  • Other complicating illness'.
  • Language difficulties that prevent answering surveys.
  • Participation in another study.
  • Accommodation outside the hospital's catchment area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County Hospital Ryhov

Jönköping, Jönköping County, 551 11, Sweden

Location

Related Publications (11)

  • Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.

    PMID: 17646231BACKGROUND

  • Dalteg T, Benzein E, Sandgren A, Fridlund B, Malm D. Managing uncertainty in couples living with atrial fibrillation. J Cardiovasc Nurs. 2014 May-Jun;29(3):E1-10. doi: 10.1097/JCN.0b013e3182a180da.

    PMID: 24108265BACKGROUND

  • Ekblad H, Ronning H, Fridlund B, Malm D. Patients' well-being: experience and actions in their preventing and handling of atrial fibrillation. Eur J Cardiovasc Nurs. 2013 Apr;12(2):132-9. doi: 10.1177/1474515112457132. Epub 2012 Aug 30.

    PMID: 22936792BACKGROUND

  • Lane DA, Langman CM, Lip GY, Nouwen A. Illness perceptions, affective response, and health-related quality of life in patients with atrial fibrillation. J Psychosom Res. 2009 Mar;66(3):203-10. doi: 10.1016/j.jpsychores.2008.10.007.

    PMID: 19232232BACKGROUND

  • Kupper N, van den Broek KC, Widdershoven J, Denollet J. Subjectively reported symptoms in patients with persistent atrial fibrillation and emotional distress. Front Psychol. 2013 Apr 24;4:192. doi: 10.3389/fpsyg.2013.00192. eCollection 2013.

    PMID: 23630509BACKGROUND

  • Smith D, Lip GY, Lane DA. Impact of symptom control on health-related quality of life in atrial fibrillation patients: the psychologist's viewpoint. Europace. 2010 May;12(5):608-10. doi: 10.1093/europace/euq083. Epub 2010 Mar 30. No abstract available.

    PMID: 20353966BACKGROUND

  • Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.

    PMID: 21263103BACKGROUND

  • Eriksson M, Lindstrom B. Antonovsky's sense of coherence scale and the relation with health: a systematic review. J Epidemiol Community Health. 2006 May;60(5):376-81. doi: 10.1136/jech.2005.041616.

    PMID: 16614325BACKGROUND

  • McCabe PJ. Psychological distress in patients diagnosed with atrial fibrillation: the state of the science. J Cardiovasc Nurs. 2010 Jan-Feb;25(1):40-51. doi: 10.1097/JCN.0b013e3181b7be36.

    PMID: 19935428BACKGROUND

  • Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.

    PMID: 21534932BACKGROUND

  • Malm D, Fridlund B, Ekblad H, Karlstrom P, Hag E, Pakpour AH. Effects of brief mindfulness-based cognitive behavioural therapy on health-related quality of life and sense of coherence in atrial fibrillation patients. Eur J Cardiovasc Nurs. 2018 Oct;17(7):589-597. doi: 10.1177/1474515118762796. Epub 2018 Mar 1.

    PMID: 29493266DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bengt Fridlund, Professor

    School of Health Sciences, Jönköping University, Jönköping Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RN, BSC, PhD-student

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 27, 2014

Study Start

September 1, 2011

Primary Completion

November 1, 2014

Study Completion

December 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

SE(1)