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

June 26, 2014 updated by: Christoph Herrmann-Lingen, University of Göttingen

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, D-37075
        • Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Collaborators

Kaufmännische Krankenkasse (KKH) (health insurance company)

Investigators

  • Study Director: Christoph Herrmann-Lingen, Prof. Dr., University of Goettingen, Department of Psychosomatik Medicine and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frauenherz - 284
  • Frauenherz-Studie-284 (Other Identifier: IFS gGmbH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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