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

NCT01244295 | Completed DMC

• 2 other identifiers: 5645R01MH070741
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Complicated Grief

Keywords

Grief; Bereavement; Psychotherapy; Randomized controlled trial; Treatment study

Outcome Measures

Primary Outcomes (1)

• Responder status on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale

  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 Outcomes (5)

• Change in score on Inventory of Complicated Grief (ICG) Scale

  Up to 48 weeks from baseline

• Change in score on Work and Social Adjustment Scale (WSAS)

  Up to 48 weeks from baseline

• Change in score on Grief Related Avoidance Questionnaire (GRAQ) Scale

  Up to 48 weeks from baseline

• Change in results from Structured Interview for Complicated Grief (SCI-CG)

  Up to 16 weeks from baseline

• Change in results on Typical Beliefs Questionnaire (TBQ)

  Up to 16 weeks from baseline

Study Arms (2)

Complicated Grief Treatment

EXPERIMENTAL

Targeted psychotherapy for complicated grief

Behavioral: Complicated Grief Treatment

Interpersonal Therapy

ACTIVE COMPARATOR

Standard IPT is a comparator treatment

Behavioral: Interpersonal Therapy

Interventions

Complicated Grief Treatment BEHAVIORAL

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.

Also known as: CGT

Complicated Grief Treatment

Interpersonal Therapy BEHAVIORAL

Standard form of interpersonal psychotherapy delivered for 16 sessions weekly.

Also known as: IPT

Interpersonal Therapy

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

• 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.

  PMID: 15928281 BACKGROUND

• 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.

  PMID: 33818302 DERIVED

• 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.

  PMID: 28501738 DERIVED

• 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.

  PMID: 25250737 DERIVED

Related Links

• Study website

Study Officials

• M. Katherine Shear, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: March 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

US (1)