Effects of a Telephone Based Peer Support to Reduce Depressive Symptoms and Improve Social Support in Women With CHD

Coronary Heart Disease Clinical Trial

Official title:

Randomized Controlled Trial of a Telephone Based Peer Support Intervention to Reduce Depressive Symptoms and Improve Social Support in Women With Coronary Heart Disease (CHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177474
• Other study ID #: Frauenherz - 284
• Secondary ID: Frauenherz-Studi
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: June 26, 2014
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2014
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

In a randomized controlled trial the investigators intended to evaluate the effect of a telephone based peer support intervention on depressed or anxious women with coronary heart disease (CHD). The investigators intended to include 198 depressed or anxious women aged over 18 years with CHD. Participants were randomized to intervention (IG) or waiting list (WL). IG was offered immediate telephone-based contact to peer counselors while WL received the offer with a 6-month delay. All participants got at least one telephone call by a clinical psychologist (study information, feedback about the individual level of distress, proposal to get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived social support (F-SozU K-14). In an additional quasi-experimental trial, the investigators included 11 peer counselors and 11 matched controls not taking part in the intervention. Main outcome variables were mood states (POMS) and perceived social support (F-SozU K-14).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• coronary heart disease

• depressive symptoms (HADS >7)

• insurants of former Kaufmännische Krankenkasse (KKH)-Allianz

• German speaking

• at least 18 years old

• written informed consent

Exclusion Criteria:

• hardness of hearing

• severe somatic illness

• current severe depressive episode or current suicidal tendency

• severe mental illness (dementia, psychosis)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Symptoms
• Heart Diseases
• Low Perceived Social Support
• Myocardial Ischemia

Intervention

Behavioral:
• Telephone based peer support

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	Kaufmännische Krankenkasse (KKH) (health insurance company)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month	PHQ-9: Patient Health Questionnaire - Depression Scale	Baseline (T1), after 5 month (T2), after 11 month (T3)	No
Primary	Change of perceived social support measured by F-SozU K-14 from baseline to 6 month	F-SozU K-14: Fragebogen zur sozialen Unterstützung (Social Support Questionnaire)	Baseline (T0), 5 month after T1 (T2), after 11 month (T3)	No
Secondary	Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month	HADS-A: Hospital Anxiety and Depression Scale - Anxiety Scale	Baseline (T1), after 5 month (T2), after 11 month (T3)	No
Secondary	Change of Self efficacy measured by SWE from baseline to 5 month	SWE: Fragebogen zur Allgemeinen Selbstwirksamkeitserwartung (Perceived self efficacy)	Baseline (T1), after 5 month (T2), after 11 month (T3)	No
Secondary	Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month	WHOQOL-BREF: The World Health Organization Quality of Life-BREF	Baseline (T1), after 5 month (T2), after 11 month (T3)	No