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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Depressive Symptoms, Low Perceived Social Support, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Telephone based peer support


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone based peer support<br>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<br> <br> |
| Other: Waitlist Group<br>Waitlist condition with delayed telephone based peer support starting at 5 months | Behavioral: Telephone based peer support<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depressive symptoms, perceived social support, coronary heart disease, peer support, women