Clinical trial NCT02177474: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Low Perceived Social Support
Coronary Heart Disease
Keywords: depressive symptoms
perceived social support
coronary heart disease
peer support
women
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Kaufmännische Krankenkasse (KKH) (health insurance company)
First posted: 2014-06-27
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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)

Primary outcomes:
measure: Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
timeFrame: Baseline (T1), after 5 month (T2), after 11 month (T3)
measure: Change of perceived social support measured by F-SozU K-14 from baseline to 6 month
timeFrame: Baseline (T0), 5 month after T1 (T2), after 11 month (T3)
Secondary outcomes:
measure: Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month
timeFrame: Baseline (T1), after 5 month (T2), after 11 month (T3)
measure: Change of Self efficacy measured by SWE from baseline to 5 month
timeFrame: Baseline (T1), after 5 month (T2), after 11 month (T3)
measure: Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month
timeFrame: Baseline (T1), after 5 month (T2), after 11 month (T3)
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen
Study officials:
affiliation: University of Goettingen, Department of Psychosomatik Medicine and Psychotherapy
name: Christoph Herrmann-Lingen, Prof. Dr.
role: STUDY_DIRECTOR
References: