Study of Interpersonal Therapy and Complicated Grief Treatment in Adults 50 Years and Older (CGTOA)

New York State Psychiatric Institute

Status

Completed

Conditions

Complicated Grief

Treatments

Behavioral: Complicated Grief Treatment

Behavioral: Interpersonal Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01244295

5645

R01MH070741 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

151 patients

Sex

All

Ages

50 to 95 years old

Volunteers

No Healthy Volunteers

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