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

Primary Purpose

Depressive Symptoms, Low Perceived Social Support, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telephone based peer support
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depressive Symptoms focused on measuring depressive symptoms, perceived social support, coronary heart disease, peer support, women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telephone based peer support

Waitlist Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
PHQ-9: Patient Health Questionnaire - Depression Scale
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)

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2014
Last Updated
June 26, 2014
Sponsor
University of Göttingen
Collaborators
Kaufmännische Krankenkasse (KKH) (health insurance company)
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1. Study Identification

Unique Protocol Identification Number
NCT02177474
Brief Title
Effects of a Telephone Based Peer Support to Reduce Depressive Symptoms and Improve Social Support in Women With CHD
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
Collaborators
Kaufmännische Krankenkasse (KKH) (health insurance company)

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Low Perceived Social Support, Coronary Heart Disease
Keywords
depressive symptoms, perceived social support, coronary heart disease, peer support, women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone based peer support
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Group
Arm Type
Other
Arm Description
Waitlist condition with delayed telephone based peer support starting at 5 months
Intervention Type
Behavioral
Intervention Name(s)
Telephone based peer support
Primary Outcome Measure Information:
Title
Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
Description
PHQ-9: Patient Health Questionnaire - Depression Scale
Time Frame
Baseline (T1), after 5 month (T2), after 11 month (T3)
Title
Change of perceived social support measured by F-SozU K-14 from baseline to 6 month
Description
F-SozU K-14: Fragebogen zur sozialen Unterstützung (Social Support Questionnaire)
Time Frame
Baseline (T0), 5 month after T1 (T2), after 11 month (T3)
Secondary Outcome Measure Information:
Title
Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month
Description
HADS-A: Hospital Anxiety and Depression Scale - Anxiety Scale
Time Frame
Baseline (T1), after 5 month (T2), after 11 month (T3)
Title
Change of Self efficacy measured by SWE from baseline to 5 month
Description
SWE: Fragebogen zur Allgemeinen Selbstwirksamkeitserwartung (Perceived self efficacy)
Time Frame
Baseline (T1), after 5 month (T2), after 11 month (T3)
Title
Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month
Description
WHOQOL-BREF: The World Health Organization Quality of Life-BREF
Time Frame
Baseline (T1), after 5 month (T2), after 11 month (T3)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Herrmann-Lingen, Prof. Dr.
Organizational Affiliation
University of Goettingen, Department of Psychosomatik Medicine and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen
City
Göttingen
ZIP/Postal Code
D-37075
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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