Clinical trial NCT01244295: Study of Interpersonal Therapy and Complicated Grief Treatment in Adults 50 Years and Older
Official title: Complicated Grief Treatment in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complicated Grief
Keywords: Grief
Bereavement
Psychotherapy
Randomized controlled trial
Treatment study
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-11-19
Enrollment: 151
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Responder status on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Week 20
Secondary outcomes:
measure: Change in score on Inventory of Complicated Grief (ICG) Scale
timeFrame: Up to 48 weeks from baseline
measure: Change in score on Work and Social Adjustment Scale (WSAS)
timeFrame: Up to 48 weeks from baseline
measure: Change in score on Grief Related Avoidance Questionnaire (GRAQ) Scale
timeFrame: Up to 48 weeks from baseline
measure: Change in results from Structured Interview for Complicated Grief (SCI-CG)
timeFrame: Up to 16 weeks from baseline
measure: Change in results on Typical Beliefs Questionnaire (TBQ)
timeFrame: Up to 16 weeks from baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: M. Katherine Shear, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lechner-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.
citation: Ghesquiere 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.
citation: Shear 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.