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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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