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

January 15, 2014 updated by: New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Complicated Grief Treatment
Targeted psychotherapy for complicated grief
Behavioral: Complicated Grief Treatment
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.
Other Names:
  • CGT
ACTIVE_COMPARATOR: Interpersonal Therapy
Standard IPT is a comparator treatment
Behavioral: Interpersonal Therapy
Standard form of interpersonal psychotherapy delivered for 16 sessions weekly.
Other Names:
  • IPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on Inventory of Complicated Grief (ICG) Scale
Time Frame: Up to 48 weeks from baseline
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.
Up to 48 weeks from baseline
Change in score on Work and Social Adjustment Scale (WSAS)
Time Frame: Up to 48 weeks from baseline
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.
Up to 48 weeks from baseline
Change in score on Grief Related Avoidance Questionnaire (GRAQ) Scale
Time Frame: Up to 48 weeks from baseline
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.
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
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.
Up to 16 weeks from baseline
Change in results on Typical Beliefs Questionnaire (TBQ)
Time Frame: Up to 16 weeks from baseline
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.
Up to 16 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: M. Katherine Shear, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (ESTIMATE)

November 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5645
  • R01MH070741 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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