Depressive SymptomsNCT02177474
Effects of a Telephone Based Peer Support to Reduce Depressive Symptoms and Improve Social Support in Women With CHD
A study testing Telephone based peer support in people with Depressive Symptoms and Low Perceived Social Support, run by University of Göttingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depressive Symptoms, Low Perceived Social Support, Coronary Heart Disease
- What is being tested?
- Telephone based peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary heart disease
- depressive symptoms (HADS >7)
- insurants of former Kaufmännische Krankenkasse (KKH)-Allianz
- German speaking
- at least 18 years old
- written informed consent
Who cannot join
- hardness of hearing
- severe somatic illness
- current severe depressive episode or current suicidal tendency
- severe mental illness (dementia, psychosis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Göttingen
Göttingen, D-37075
About this study
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)
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).
- Being tested
- Telephone based peer support
- Keywords
- depressive symptoms, perceived social support, coronary heart disease, peer support, women
- Medical subject headings
- Depression, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone based peer supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone based peer support | Experimental | 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. Receives: Behavioral: Telephone based peer support |
| Waitlist Group | Other | Waitlist condition with delayed telephone based peer support starting at 5 months Receives: Behavioral: Telephone based peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
PHQ-9: Patient Health Questionnaire - Depression Scale
Measured: 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)
Measured: Baseline (T0), 5 month after T1 (T2), after 11 month (T3)
Secondary outcomes (3)
Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month
HADS-A: Hospital Anxiety and Depression Scale - Anxiety Scale
Measured: 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)
Measured: 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
Measured: Baseline (T1), after 5 month (T2), after 11 month (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- Kaufmännische Krankenkasse (KKH) (health insurance company)
- Responsible party
- Principal investigator, Christoph Herrmann-Lingen, University of Göttingen
- Investigators
- Christoph Herrmann-Lingen, Prof. Dr., Study director, University of Goettingen, Department of Psychosomatik Medicine and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177474
- Sponsor's protocol ID
- Frauenherz - 284
- Other IDs
- Frauenherz-Studie-284
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02177474
- Acronym / sponsor ID
- Frauenherz - 284
- Keywords
- depressive symptoms, perceived social support, coronary heart disease, peer support, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- Kaufmännische Krankenkasse (KKH) (health insurance company)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone based peer support | Experimental | Behavioral: Telephone based peer supportThe 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 Group | Other | Behavioral: Telephone based peer supportWaitlist condition with delayed telephone based peer support starting at 5 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- coronary heart disease
- depressive symptoms (HADS >7)
- insurants of former Kaufmännische Krankenkasse (KKH)-Allianz
- German speaking
- at least 18 years old
Key exclusion criteria (4 listed)
- hardness of hearing
- severe somatic illness
- current severe depressive episode or current suicidal tendency
- severe mental illness (dementia, psychosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone based peer support | Behavioural | Telephone based peer support, Waitlist Group |
Primary outcome
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)
3 secondary outcomes
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)
Change of Self efficacy measured by SWE from baseline to 5 month
Time frame: Baseline (T1), after 5 month (T2), after 11 month (T3)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Herrmann-Lingen, Prof. Dr. study director
University of Goettingen, Department of Psychosomatik Medicine and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone based peer support in people with Depressive Symptoms and Low Perceived Social Support, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.