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

Sponsor

University of Göttingen (Other)

Overall Status

Completed

CT.gov ID

NCT02177474

Collaborator

Kaufmännische Krankenkasse (KKH) (health insurance company) (Other)

108

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms Low Perceived Social Support Coronary Heart Disease	Behavioral: Telephone based peer support	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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)

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone based peer support The telephone based peer support was delivered by 11 women with chd aged 54 to 73 years, living all over Germany. Participants could call according to their needs during scheduled times on workdays.	Behavioral: Telephone based peer support
Other: Waitlist Group Waitlist condition with delayed telephone based peer support starting at 5 months	Behavioral: Telephone based peer support

Arm

Intervention/Treatment

Experimental: Telephone based peer support

The telephone based peer support was delivered by 11 women with chd aged 54 to 73 years, living all over Germany. Participants could call according to their needs during scheduled times on workdays.

Behavioral: Telephone based peer support

Other: Waitlist Group

Waitlist condition with delayed telephone based peer support starting at 5 months

Behavioral: Telephone based peer support

Outcome Measures

Primary Outcome Measures

Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month [Baseline (T1), after 5 month (T2), after 11 month (T3)]
PHQ-9: Patient Health Questionnaire - Depression Scale
Change of perceived social support measured by F-SozU K-14 from baseline to 6 month [Baseline (T0), 5 month after T1 (T2), after 11 month (T3)]
F-SozU K-14: Fragebogen zur sozialen Unterstützung (Social Support Questionnaire)

Secondary Outcome Measures

Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month [Baseline (T1), after 5 month (T2), after 11 month (T3)]
HADS-A: Hospital Anxiety and Depression Scale - Anxiety Scale
Change of Self efficacy measured by SWE from baseline to 5 month [Baseline (T1), after 5 month (T2), after 11 month (T3)]
SWE: Fragebogen zur Allgemeinen Selbstwirksamkeitserwartung (Perceived self efficacy)
Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month [Baseline (T1), after 5 month (T2), after 11 month (T3)]
WHOQOL-BREF: The World Health Organization Quality of Life-BREF