DepressionNCT02325167
Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
A study testing EBT and treatment-as-usual in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in informal caregivers of palliative patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression
- What is being tested?
- EBT and treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jan 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 21 years of age
- informal caregivers of palliative patients at last stage of life and during bereavement;
- fluent German language skills
Who cannot join
- psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.;
- pronounced cognitive impairment e.g. delirium, dementia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in informal caregivers of palliative patients.
Read the detailed description
The investigators have developed and pilot-tested a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to reduce psychological distress in informal caregivers of palliative patients. The investigators propose to conduct a two-arm randomised controlled trial (RCT) to test the effectiveness of EBT against usual care for the reduction of distress and the promotion of quality of life.
Two one-to-one manualised psychotherapeutic sessions will be compared to a treatment-as-usual control group.Treatment-as-usual includes two supportive sessions.
The design will be an unblinded RCT consisting of two conditions (EBT and Treatment-as-usual), with assessment at pre- and post-treatment and follow-ups at four weeks and six months. The trial will take place in the Clinic of Palliative Care, University of Munich (Klinik und Poliklinik für Palliativmedizin der LMU München).
- Conditions
- Depression
- Being tested
- EBT, treatment-as-usual
- Keywords
- informal caregivers, mental stress, quality of life, psychotherapeutic intervention
- Medical subject headings
- Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBTBehavioural
participants assigned to the intervention arm will receive 2 manualised therapy sessions with focus on mindfulness and activating resources delivered by trained therapists at the Clinic of Palliative Care
treatment-as-usualBehavioural
participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care
| Study group | Role | What they receive |
|---|---|---|
| EBT | Experimental | Not described Receives: Behavioral: EBT |
| Treatment-as-usual | Experimental | Not described Receives: Behavioral: treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
A reliable and valid 9-item measure of depression
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Secondary outcomes (8)
Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
two mood scales, one that measures positive affect and the other which measures negative affect
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Satisfaction with Life Scale (SWLS; Diener et al., 1985)
a short 5-item instrument designed to measure global cognitive judgments of satisfaction with life
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)
an abbreviated 26-item generic Quality of Life Scale developed through the World Health Organisation measuring physical health, psychological health, social relationships, and environment
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Numeric rating scale for mental stress and quality of life (NRS, range 0-10)
a numeric scale used for the subjective measurement of mental stress and quality of life
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)
a 7-item self-report measure designed to screen and assess the severity of generalised anxiety disorder symptoms
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)
a german questionnaire for health-related resource use
Measured: Baseline; 6 months follow-up
German version of the NCCN distress-thermometer (Mehnert et al., 2005)
a subjective measurement of distress on a 0-10 scale
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
General Health Questionnaire (GHQ-12, Goldberg et al., 1972)
a 12-item self-report measure of psychological morbidity
Measured: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Stifterverband für die Deutsche Wissenschaft
- Responsible party
- Principal investigator, Martin Fegg, Ludwig-Maximilians - University of Munich
- Investigators
- Martin Fegg, Dr., Principal investigator, Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325167
- Sponsor's protocol ID
- 545-12
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2014
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02325167
- Acronym / sponsor ID
- 545-12
- Conditions
- Depression
- Keywords
- informal caregivers, mental stress, quality of life, psychotherapeutic intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Stifterverband für die Deutsche Wissenschaft
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Dec 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.
The purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in informal caregivers of palliative patients.
Detailed description
The investigators have developed and pilot-tested a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to reduce psychological distress in informal caregivers of palliative patients. The investigators propose to conduct a two-arm randomised controlled trial (RCT) to test the effectiveness of EBT against usual care for the reduction of distress and the promotion of quality of life.
Two one-to-one manualised psychotherapeutic sessions will be compared to a treatment-as-usual control group.Treatment-as-usual includes two supportive sessions.
The design will be an unblinded RCT consisting of two conditions (EBT and Treatment-as-usual), with assessment at pre- and post-treatment and follow-ups at four weeks and six months. The trial will take place in the Clinic of Palliative Care, University of Munich (Klinik und Poliklinik für Palliativmedizin der LMU München).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBT | Experimental | Behavioral: EBT |
| Treatment-as-usual | Experimental | Behavioral: treatment-as-usual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 21 years of age
- informal caregivers of palliative patients at last stage of life and during bereavement;
- fluent German language skills
Key exclusion criteria (2 listed)
- psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.;
- pronounced cognitive impairment e.g. delirium, dementia
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 |
|---|---|---|
| EBTparticipants assigned to the intervention arm will receive 2 manualised therapy sessions with focus on mindfulness and activating resources delivered by trained therapists at the Clinic of Palliative Care | Behavioural | EBT |
| treatment-as-usualparticipants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care | Behavioural | Treatment-as-usual |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
A reliable and valid 9-item measure of depression
8 secondary outcomes
Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Satisfaction with Life Scale (SWLS; Diener et al., 1985)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Numeric rating scale for mental stress and quality of life (NRS, range 0-10)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)
Time frame: Baseline; 6 months follow-up
German version of the NCCN distress-thermometer (Mehnert et al., 2005)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
General Health Questionnaire (GHQ-12, Goldberg et al., 1972)
Time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up
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 14 Aug 2019.
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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.
Martin Fegg, Dr. principal investigator
Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBT and treatment-as-usual in people with Depression, run by Ludwig-Maximilians - University of Munich 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 3 inclusion and 2 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 14 Aug 2019. 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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up). 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 14 Aug 2019.