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Clinical Trials/NCT02177474
NCT02177474
Completed
N/A

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)

University of Göttingen1 site in 1 country108 target enrollmentOctober 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Göttingen
Enrollment
108
Locations
1
Primary Endpoint
Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
Status
Completed
Last Updated
11 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Göttingen
Responsible Party
Principal Investigator
Principal Investigator

Christoph Herrmann-Lingen

Prof. Dr.

University of Göttingen

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)

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

  • Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))
  • Change of Self efficacy measured by SWE from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))
  • Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))

Study Sites (1)

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