Study of Interpersonal Therapy and Complicated Grief Treatment in Adults 50 Years and Older (CGTOA)
|ClinicalTrials.gov Identifier: NCT01244295|
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : January 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Complicated Grief||Behavioral: Complicated Grief Treatment Behavioral: Interpersonal Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Complicated Grief Treatment in Older Adults|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
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 Name: 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 Name: IPT
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244295
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||M. Katherine Shear, MD||Columbia University|