Cognitive Therapy for Suicidal Older Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01535482
First received: August 25, 2011
Last updated: May 8, 2014
Last verified: February 2012
  Purpose

The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.


Condition Intervention Phase
Suicide, Attempted
Behavioral: Cognitive Therapy
Behavioral: Enhanced Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Therapy for Suicidal Older Men

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in baseline suicidal ideation [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • depression [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • hopelessness [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • social problem solving skills [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • complicated grief [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • reasons for living and dying [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • perceived social support [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Cognitive Executive Functioning [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.


Estimated Enrollment: 122
Study Start Date: September 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Therapy
A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.
Behavioral: Cognitive Therapy
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
Active Comparator: Enhanced Usual Care
Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists.
Behavioral: Enhanced Usual Care
Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.

Detailed Description:

Older adult males have the highest suicide rate of any age group in the U.S. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.

Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enhanced usual care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
  2. Male
  3. 50 years of age or older
  4. Able to speak English
  5. Able to provide written informed consent
  6. Able to attend study assessment and therapy sessions
  7. Able to provide at least two verifiable contacts for tracking purposes
  8. Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.

Exclusion Criteria:

  1. Needed priority treatment for a substance use disorder as determined by the referring clinician.
  2. Needed priority treatment for PTSD as determined by the referring clinician.
  3. Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535482

Contacts
Contact: Gregory K Brown, Ph.D. 215-898-4104 gregbrow@mail.med.upenn.edu

Locations
United States, Pennsylvania
Aaron T. Beck Psychopathology Research Center - University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gregory K Brown, Ph.D.    215-898-4104    gregbrow@mail.med.upenn.edu   
Principal Investigator: Gregory K. Brown, Ph.D.         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01535482     History of Changes
Other Study ID Numbers: R01MH086572-01A2, 1R01MH086572-01A2
Study First Received: August 25, 2011
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Cognitive therapy
Suicide
Older men
suicide ideation

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on October 20, 2014