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Completed

NCT Number: NCT02177474

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

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Coronary Heart Disease Depression Heart Diseases Low Perceived Social Support Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen

Göttingen, D-37075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telephone based peer support

Behavioral

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • Kaufmännische Krankenkasse (KKH) (health insurance company)

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2014
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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