Stress and Ischemic Heart Disease. The Effect of Bio Feedback Guided Stress Management on Life Quality Including Signs of Depression and Stress

NCT ID: NCT01513824

Last Updated: 2014-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of the study is to examine if bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure reduces signs of depression and number clinical stress signs and increases quality of life in patients with stable, ischemic heart disease

Detailed Description

Primary outcome Measure:

MDI depression score (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory

Secondary outcome measures:

1. Clinical stress signs and quality of life measures (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, on a Clinical Stress Signs score (56 items), SF-36 and WHO-5 questionnaires

2. Measure of Pressure Pain Sensitivity by a professional (designated as safety issue: no) The effect of 3 months twice daily measurements of pressure pain sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which acupressure is mandatory

3. Measures of heart function: Blood pressure, the Pressure-Pulse Product (heart work), Heart Rate Variability inclusive response to Tilting, BNP (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory

4. Measures of the Metabolic Syndrome: HOMA-1, Adiponectin, HBA1C, Lipids, Body Composition (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory

Tertiary outcome Measures:

Use of health care (time frame one year after start of intervention) The effect of months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, followed by 9 months bioguided feedback stress management when needed, i.e. post-study maintenance treatment

Conditions

Biofeed Back Guided Stress Management; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

stress management, acupressure

bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure´for 3 months

Group Type: ACTIVE_COMPARATOR

pressure pain sensitivity measure followed bu acupressure

Intervention Type: BEHAVIORAL

twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.

bio feedback guided, stress management

control without treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pressure pain sensitivity measure followed bu acupressure

twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with documented stable, ischemic heart disease who have finished heart rehabilitation according to the National Guidelines > 6 months ago Actual use of aspirin, statins, and blood pressure medication according to the National Guidelines
• Age < 75 years
• Increased pressure pain sensitivity ≥60 as a sign of persistent stress

Exclusion Criteria

• Previous diagnosed and treated psychiatric disease besides depression Other Chronic Disease with known significantly reduced life expectancy (as cancer or severe COPD)
• Other Chronic Disease with known significantly reduced Quality of Life as COPD, chronic pain conditions (but not diabetes or heart disease)
• Planned heart operation
• Changed Medication for the Heart (concerning Angina or Heart Failure) within one month
• Previous use of the Pressure Pain Sensitivity Device followed by treatment with Acupressure

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jens Faber

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medicine, Herlev Hospital

Herlev, Herlev, Denmark

Countries

Denmark

References

Bergmann N, Ballegaard S, Bech P, Hjalmarson A, Krogh J, Gyntelberg F, Faber J. The effect of daily self-measurement of pressure pain sensitivity followed by acupressure on depression and quality of life versus treatment as usual in ischemic heart disease: a randomized clinical trial. PLoS One. 2014 May 21;9(5):e97553. doi: 10.1371/journal.pone.0097553. eCollection 2014.

Reference Type: DERIVED

PMID: 24849077 (View on PubMed)

Other Identifiers

SongHeart

Identifier Type: -

Identifier Source: org_study_id