GriefCG-CBTNCT01433653
Cognitive Behavioral Therapy for Complicated Grief
A study testing Cognitive Behavioral Therapy for Complicated Grief in people with Grief, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief
- What is being tested?
- Cognitive Behavioral Therapy for Complicated Grief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Feb 2011
- 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
- age complicated grief diagnosis
Who cannot join
- acute suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief
The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group.
- Conditions
- Grief
- Being tested
- Cognitive Behavioral Therapy for Complicated Grief
- Keywords
- Comorbid, Complicated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Complicated GriefBehavioural
Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.
| Study group | Role | What they receive |
|---|---|---|
| CG-CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Complicated Grief |
| wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-13 (Prolonged Grief Interview - 13 Item version)
Measured: Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Secondary outcomes (2)
Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI)
Measured: Change between intake (t1) and end of treatment (t2) in general distress symptoms within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Comorbid Diagnoses by DIA-X-Interview
Measured: Change between intake (t1) and end of treatment (t2) in number of comorbid psychiatric diagnoses within 5 months; t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startMay 2005
- Primary completionFeb 2011
- Study completionFeb 2011
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 GriefStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Rosner, Ludwig-Maximilians - University of Munich
- Investigators
- Rita Rosner, Dr. phil., Principal investigator, LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433653
- Sponsor's protocol ID
- LMU-KlinPsy001
- Acronym
- CG-CBT
- Status last verified
- Jun 2015
- First submitted
- 18 Jul 2011
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosner R, Pfoh G, Kotoucova M, Hagl M. Efficacy of an outpatient treatment for prolonged grief disorder: a randomized controlled clinical trial. J Affect Disord. 2014;167:56-63. doi: 10.1016/j.jad.2014.05.035. Epub 2014 Jun 2.
PubMed 25082115Rosner R, Bartl H, Pfoh G, Kotoucova M, Hagl M. Efficacy of an integrative CBT for prolonged grief disorder: A long-term follow-up. J Affect Disord. 2015 Sep 1;183:106-12. doi: 10.1016/j.jad.2015.04.051. Epub 2015 May 8.
PubMed 26001670
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief
- ClinicalTrials.gov ID
- NCT01433653
- Acronym / sponsor ID
- CG-CBT / LMU-KlinPsy001
- Conditions
- Grief
- Keywords
- Comorbid, Complicated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Sep 2011 (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 this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG-CBT | Experimental | Behavioral: Cognitive Behavioral Therapy for Complicated Grief |
| wait list control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age complicated grief diagnosis
Key exclusion criteria (1 listed)
- acute suicidality
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Complicated GriefManualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring. | Behavioural | CG-CBT |
Primary outcome
PG-13 (Prolonged Grief Interview - 13 Item version)
Time frame: Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
2 secondary outcomes
Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI)
Time frame: Change between intake (t1) and end of treatment (t2) in general distress symptoms within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Comorbid Diagnoses by DIA-X-Interview
Time frame: Change between intake (t1) and end of treatment (t2) in number of comorbid psychiatric diagnoses within 5 months; t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
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 9 Jun 2015.
- Results publication: PubMed 25082115Rosner R, Pfoh G, Kotoucova M, Hagl M. Efficacy of an outpatient treatment for prolonged grief disorder: a randomized controlled clinical trial. J Affect Disord. 2014;167:56-63. doi: 10.1016/j.jad.2014.05.035. Epub 2014 Jun 2.
- Results publication: PubMed 26001670Rosner R, Bartl H, Pfoh G, Kotoucova M, Hagl M. Efficacy of an integrative CBT for prolonged grief disorder: A long-term follow-up. J Affect Disord. 2015 Sep 1;183:106-12. doi: 10.1016/j.jad.2015.04.051. Epub 2015 May 8.
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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.
Rita Rosner, Dr. phil. principal investigator
LMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Complicated Grief in people with Grief, 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 1 inclusion and 1 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 9 Jun 2015. 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?
PG-13 (Prolonged Grief Interview - 13 Item version) (time frame: Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)). 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 NCT01433653, 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 9 Jun 2015.