Complicated GriefCGTOANCT01244295
Study of Interpersonal Therapy and Complicated Grief Treatment in Adults 50 Years and Older
A study testing Complicated Grief Treatment and Interpersonal Therapy in people with Complicated Grief, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
A comparison study of 16 week treatment with either specialized psychotherapy for complicated grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with complicated grief. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Complicated Grief
- What is being tested?
- Complicated Grief Treatment and Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2013
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complicated Grief is the most important problem
- Ability to give informed consent
- Fluent in English
- Willingness to have sessions audiotaped
- Willing to undergo random assignment
Who cannot join
- Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse or positive urine toxicology exam, Bipolar Disorder, current manic episode, Dementia
- Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis
- Pending or active disability claim or lawsuit related to the death
- Concurrent psychosocial therapy
- Judged to be at serious risk to self or others
- For people currently taking antidepressant medications, to be included in the study they must be on the medication for at least 3 months and for at least 6 weeks on the same dose
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Complicated Grief Treatment in Older Adults
A comparison study of 16 week treatment with either specialized psychotherapy for complicated grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with complicated grief.
Read the detailed description
According to the National Council on Aging (1), in 2005, there were more than 10 million older Americans who were widowed (8.6 million women (43%) and 2.1 million men (14%) over the age of 65). These people are at risk for a debilitating reaction called Traumatic or Complicated Grief (CG: the term now used for this condition). Studies confirm that Complicated Grief can be reliably identified and occurs in about 10-20% of bereaved individuals. CG appears to carry much of the risk for negative outcomes of bereavement. CG can affect health status and influence decisions about personal health care. The risk of hypertension is 10 times greater among widowed subjects who meet consensus criteria for CG compared to those who do not, while subjects with CG are 17 times less likely to have visited a physician in the months since the death. Despite its high prevalence and significant morbidity, there are no proven efficacious treatments. The PI of this project developed a novel psychotherapy called Complicated Grief Treatment (CGT), and has now completed a study (MH60783) comprised of adults over age 18, that confirmed efficacy of this approach. Participants ≥ age 60 (n=29) were less likely to be employed and more likely to live alone. We observed better response to CGT than IPT, as in younger adults. However, confirmation of efficacy among seniors is important, since older people have different vulnerabilities and different problems in adjusting to grief than younger adults. We plan to conduct a randomized controlled study of CGT v IPT in individuals > 50 years of age who meet criteria for complicated grief and have no contraindications to study participation. Our specific aims are: 1) To compare results of 16 sessions of either CGT or standard IPT. We hypothesize that CGT will produce a higher response rate and shorter time to response than IPT, and that responders will show significantly greater reduction in associated symptoms and impairment than non-responders.
- Conditions
- Complicated Grief
- Being tested
- Complicated Grief Treatment, Interpersonal Therapy
- Keywords
- Grief, Bereavement, Psychotherapy, Randomized controlled trial, Treatment study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complicated Grief TreatmentBehavioural
Also called CGT
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided weekly.
Interpersonal TherapyBehavioural
Also called IPT
Standard form of interpersonal psychotherapy delivered for 16 sessions weekly.
| Study group | Role | What they receive |
|---|---|---|
| Complicated Grief Treatment | Experimental | Targeted psychotherapy for complicated grief Receives: Behavioral: Complicated Grief Treatment |
| Interpersonal Therapy | Active comparator | Standard IPT is a comparator treatment Receives: Behavioral: Interpersonal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder status on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale
Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. The rating will be done by the Independent Evaluator.
Measured: Week 20
Secondary outcomes (5)
Change in score on Inventory of Complicated Grief (ICG) Scale
The ICG is a 19-item self-report instrument that assesses symptoms of CG. This scale has been utilized previously in treatment studies of CG. Random regression model will be applied to evaluate the score trajectory from baseline to week 20 and from week 20 to week 48.
Measured: Up to 48 weeks from baseline
Change in score on Work and Social Adjustment Scale (WSAS)
The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Random regression model will be applied to evaluate the score trajectory from baseline to week 20 and from week 20 to week 48.
Measured: Up to 48 weeks from baseline
Change in score on Grief Related Avoidance Questionnaire (GRAQ) Scale
GRAQ is a questionnaire developed by the study investigators to elicit information related to avoidance of common situations and activities following the death. This scale has good psychometric properties and will be used to assess avoidance as a possible moderator predicting better outcome with CGT. It will be analyzed using random regression model.
Measured: Up to 48 weeks from baseline
Change in results from Structured Interview for Complicated Grief (SCI-CG)
The SCI-CG is a clinician-administered structured interview developed for the study. It includes a composite of diagnostic criteria proposed by Horowitz and Prigerson. The interview was piloted and refined in the initial phase of current study.
Measured: Up to 16 weeks from baseline
Change in results on Typical Beliefs Questionnaire (TBQ)
TBQ is a 34 item questionnaire evaluating how strongly subjects endorse certain beliefs that are common during bereavement related to self, the relationship, and perceptions of the world.
Measured: Up to 16 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startMar 2008
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complicated 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- M. Katherine Shear, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244295
- Sponsor's protocol ID
- 5645
- Other IDs
- R01MH070741
- Acronym
- CGTOA
- Status last verified
- Jan 2014
- First submitted
- 18 Nov 2010
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.
PubMed 15928281Lechner-Meichsner F, Mauro C, Skritskaya NA, Shear MK. Change in avoidance and negative grief-related cognitions mediates treatment outcome in older adults with prolonged grief disorder. Psychother Res. 2022 Jan;32(1):91-103. doi: 10.1080/10503307.2021.1909769. Epub 2021 Apr 5.
PubMed 33818302Ghesquiere A, Theresa Schwartz, Wang Y, Mauro C, Skritskaya N, Shear MK. Performance and psychometric properties of the Interpersonal Support Evaluation List (ISEL) in older adults with Complicated Grief. J Affect Disord. 2017 Aug 15;218:388-393. doi: 10.1016/j.jad.2017.05.004. Epub 2017 May 7.
PubMed 28501738Shear MK, Wang Y, Skritskaya N, Duan N, Mauro C, Ghesquiere A. Treatment of complicated grief in elderly persons: a randomized clinical trial. JAMA Psychiatry. 2014 Nov;71(11):1287-95. doi: 10.1001/jamapsychiatry.2014.1242.
PubMed 25250737
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complicated Grief Treatment in Older Adults
- ClinicalTrials.gov ID
- NCT01244295
- Acronym / sponsor ID
- CGTOA / 5645
- Conditions
- Complicated Grief
- Keywords
- Grief, Bereavement, Psychotherapy, Randomized controlled trial, Treatment study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Nov 2010 (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.
A comparison study of 16 week treatment with either specialized psychotherapy for complicated grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with complicated grief.
Detailed description
According to the National Council on Aging (1), in 2005, there were more than 10 million older Americans who were widowed (8.6 million women (43%) and 2.1 million men (14%) over the age of 65). These people are at risk for a debilitating reaction called Traumatic or Complicated Grief (CG: the term now used for this condition). Studies confirm that Complicated Grief can be reliably identified and occurs in about 10-20% of bereaved individuals. CG appears to carry much of the risk for negative outcomes of bereavement. CG can affect health status and influence decisions about personal health care. The risk of hypertension is 10 times greater among widowed subjects who meet consensus criteria for CG compared to those who do not, while subjects with CG are 17 times less likely to have visited a physician in the months since the death. Despite its high prevalence and significant morbidity, there are no proven efficacious treatments. The PI of this project developed a novel psychotherapy called Complicated Grief Treatment (CGT), and has now completed a study (MH60783) comprised of adults over age 18, that confirmed efficacy of this approach. Participants ≥ age 60 (n=29) were less likely to be employed and more likely to live alone. We observed better response to CGT than IPT, as in younger adults. However, confirmation of efficacy among seniors is important, since older people have different vulnerabilities and different problems in adjusting to grief than younger adults. We plan to conduct a randomized controlled study of CGT v IPT in individuals > 50 years of age who meet criteria for complicated grief and have no contraindications to study participation. Our specific aims are: 1) To compare results of 16 sessions of either CGT or standard IPT. We hypothesize that CGT will produce a higher response rate and shorter time to response than IPT, and that responders will show significantly greater reduction in associated symptoms and impairment than non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complicated Grief Treatment | Experimental | Behavioral: Complicated Grief TreatmentTargeted psychotherapy for complicated grief |
| Interpersonal Therapy | Active comparator | Behavioral: Interpersonal TherapyStandard IPT is a comparator treatment |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Complicated Grief is the most important problem
- Ability to give informed consent
- Fluent in English
- Willingness to have sessions audiotaped
- Willing to undergo random assignment
Key exclusion criteria (6 listed)
- Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse or positive urine toxicology exam, Bipolar Disorder, current manic episode, Dementia
- Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis
- Pending or active disability claim or lawsuit related to the death
- Concurrent psychosocial therapy
- Judged to be at serious risk to self or others
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 |
|---|---|---|
| Complicated Grief TreatmentAlso: CGTComplicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided weekly. | Behavioural | Complicated Grief Treatment |
| Interpersonal TherapyAlso: IPTStandard form of interpersonal psychotherapy delivered for 16 sessions weekly. | Behavioural | Interpersonal Therapy |
Primary outcome
Responder status on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale
Time frame: Week 20
Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. The rating will be done by the Independent Evaluator.
5 secondary outcomes
Change in score on Inventory of Complicated Grief (ICG) Scale
Time frame: Up to 48 weeks from baseline
Change in score on Work and Social Adjustment Scale (WSAS)
Time frame: Up to 48 weeks from baseline
Change in score on Grief Related Avoidance Questionnaire (GRAQ) Scale
Time frame: Up to 48 weeks from baseline
Change in results from Structured Interview for Complicated Grief (SCI-CG)
Time frame: Up to 16 weeks from baseline
Change in results on Typical Beliefs Questionnaire (TBQ)
Time frame: Up to 16 weeks from baseline
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 16 Jan 2014.
- Background: PubMed 15928281Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.
- Derived from this study: PubMed 33818302Lechner-Meichsner F, Mauro C, Skritskaya NA, Shear MK. Change in avoidance and negative grief-related cognitions mediates treatment outcome in older adults with prolonged grief disorder. Psychother Res. 2022 Jan;32(1):91-103. doi: 10.1080/10503307.2021.1909769. Epub 2021 Apr 5.
- Derived from this study: PubMed 28501738Ghesquiere A, Theresa Schwartz, Wang Y, Mauro C, Skritskaya N, Shear MK. Performance and psychometric properties of the Interpersonal Support Evaluation List (ISEL) in older adults with Complicated Grief. J Affect Disord. 2017 Aug 15;218:388-393. doi: 10.1016/j.jad.2017.05.004. Epub 2017 May 7.
- Derived from this study: PubMed 25250737Shear MK, Wang Y, Skritskaya N, Duan N, Mauro C, Ghesquiere A. Treatment of complicated grief in elderly persons: a randomized clinical trial. JAMA Psychiatry. 2014 Nov;71(11):1287-95. doi: 10.1001/jamapsychiatry.2014.1242.
Related trials for Complicated Grief
Recruiting
Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder
Prolonged Grief Disorder, Complicated Grief
Not yet recruiting
Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
Insomnia, Insomnia Chronic
Active, not recruitingObservational study
The Aarhus Bereavement Study
Grief
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.
M. Katherine Shear, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complicated Grief Treatment and Interpersonal Therapy in people with Complicated Grief, run by New York State Psychiatric Institute at 1 site in United States.
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 6 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 16 Jan 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 United States. 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?
Responder status on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale (time frame: Week 20). 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 NCT01244295, which also lists 4 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 16 Jan 2014.