DepressionNCT02051660
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)
A study testing Manualized CALM intervention and Non-manualized supportive intervention. in people with Depression and Psychological Distress, run by University of Leipzig at 2 sites in Germany.
Trial summary
Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Psychological Distress
- What is being tested?
- Manualized CALM intervention and Non-manualized supportive intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2013to Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Fluency in German
- No cognitive impairment indicated in the medical record or by the attending oncologist
- Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)
- PHQ-9 depression score >=9 or Distress thermometer score >=5
Who cannot join
- Major communication difficulties (including language barriers)
- Inability to commit to the required 3-6 psychotherapy sessions
- A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
- A score <70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation
- Being in psychotherapy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
Leipzig, Saxony, 04103
About this study
Official title: German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.
Read the detailed description
Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.
- Conditions
- Depression, Psychological Distress
- Being tested
- Manualized CALM intervention, Non-manualized supportive intervention.
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualized CALM interventionBehavioural
Also called Managing Cancer and Living Meaning Cancer (CALM)
Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
Non-manualized supportive intervention.Behavioural
Supportive psycho-oncological intervention.
| Study group | Role | What they receive |
|---|---|---|
| Manualized CALM Intervention | Experimental | Not described Receives: Behavioral: Manualized CALM intervention |
| Non-manualized supportive intervention | Active comparator | Not described Receives: Behavioral: Non-manualized supportive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression module of the Patient Health Questionnaire (PHQ-9)
A reliable and valid 9-item measure of depression.
Measured: 6-months
Beck Depression-Inventory II (BDI-II)
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid, University of Hamburg-Eppendorf, University Health Network, Toronto
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Anja Mehnert, Prof Dr, Principal investigator, University Medical Center of LeipzigMartin Härter, Prof Dr Dr, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051660
- Sponsor's protocol ID
- DKH-110746
- Other IDs
- DKH-109967
- Status last verified
- May 2019
- First submitted
- 29 Jan 2014
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scheffold K, Philipp R, Vehling S, Koranyi S, Engelmann D, Schulz-Kindermann F, Harter M, Mehnert-Theuerkauf A. Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients. Support Care Cancer. 2019 Nov;27(11):4317-4325. doi: 10.1007/s00520-019-04744-x. Epub 2019 Mar 18.
PubMed 30887126Scheffold K, Philipp R, Engelmann D, Schulz-Kindermann F, Rosenberger C, Oechsle K, Harter M, Wegscheider K, Lordick F, Lo C, Hales S, Rodin G, Mehnert A. Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. BMC Cancer. 2015 Aug 19;15:592. doi: 10.1186/s12885-015-1589-y.
PubMed 26286128
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Randomized Controlled Trial of the Psychotherapeutic Intervention for Advanced Cancer Patients: Managing Cancer and Living Meaningfully (CALM)
- ClinicalTrials.gov ID
- NCT02051660
- Acronym / sponsor ID
- DKH-110746
- Conditions
- Depression, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Cancer Aid, University of Hamburg-Eppendorf, University Health Network, Toronto
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Jan 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.
Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.
Detailed description
Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manualized CALM Intervention | Experimental | Behavioral: Manualized CALM intervention |
| Non-manualized supportive intervention | Active comparator | Behavioral: Non-manualized supportive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- Fluency in German
- No cognitive impairment indicated in the medical record or by the attending oncologist
- Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)
- PHQ-9 depression score >=9 or Distress thermometer score >=5
Key exclusion criteria (5 listed)
- Major communication difficulties (including language barriers)
- Inability to commit to the required 3-6 psychotherapy sessions
- A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
- A score <70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation
- Being in psychotherapy
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 |
|---|---|---|
| Manualized CALM interventionAlso: Managing Cancer and Living Meaning Cancer (CALM)Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease. | Behavioural | Manualized CALM Intervention |
| Non-manualized supportive intervention.Supportive psycho-oncological intervention. | Behavioural | Non-manualized supportive intervention |
Primary outcome
Depression module of the Patient Health Questionnaire (PHQ-9)
Time frame: 6-months
A reliable and valid 9-item measure of depression.
Beck Depression-Inventory II (BDI-II)
Time frame: 6-months
A reliable and valid 21-item self-report instrument for evaluating the severity of depression.
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 24 May 2019.
- Derived from this study: PubMed 30887126Scheffold K, Philipp R, Vehling S, Koranyi S, Engelmann D, Schulz-Kindermann F, Harter M, Mehnert-Theuerkauf A. Spiritual well-being mediates the association between attachment insecurity and psychological distress in advanced cancer patients. Support Care Cancer. 2019 Nov;27(11):4317-4325. doi: 10.1007/s00520-019-04744-x. Epub 2019 Mar 18.
- Derived from this study: PubMed 26286128Scheffold K, Philipp R, Engelmann D, Schulz-Kindermann F, Rosenberger C, Oechsle K, Harter M, Wegscheider K, Lordick F, Lo C, Hales S, Rodin G, Mehnert A. Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. BMC Cancer. 2015 Aug 19;15:592. doi: 10.1186/s12885-015-1589-y.
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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.
Anja Mehnert, Prof Dr principal investigator
University Medical Center of Leipzig
Martin Härter, Prof Dr Dr principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualized CALM intervention and Non-manualized supportive intervention. in people with Depression and Psychological Distress, run by University of Leipzig at 2 sites 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 5 inclusion and 5 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 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Depression module of the Patient Health Questionnaire (PHQ-9) (time frame: 6-months). 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?
On the ClinicalTrials.gov record for NCT02051660, which also lists 2 linked publications.
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 24 May 2019.