Cognitive Therapy for Suicidal Older Men

Suicide, Attempted Clinical Trial

Official title:

Cognitive Therapy for Suicidal Older Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535482
• Other study ID #: R01MH086572-01A2
• Secondary ID: 1R01MH086572-01A
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: June 7, 2017
• Start date: September 2011
• Est. completion date: April 6, 2017

Study information

• Verified date: June 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Cognitive Therapy
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
• 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.

Locations

Country	Name	City	State
United States	Aaron T. Beck Psychopathology Research Center - University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline suicidal ideation		baseline, 1, 3, 6, 9, 12 months
Secondary	depression		baseline, 1, 3, 6, 9, 12 months
Secondary	hopelessness		baseline, 1, 3, 6, 9, 12 months
Secondary	quality of life		baseline, 1, 3, 6, 9, 12 months
Secondary	social problem solving skills		baseline, 1, 3, 6, 9, 12 months
Secondary	complicated grief		baseline, 1, 3, 6, 9, 12 months
Secondary	reasons for living and dying		baseline, 1, 3, 6, 9, 12 months
Secondary	perceived social support		baseline, 1, 3, 6, 9, 12 months
Secondary	Cognitive Executive Functioning	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.	baseline, 1, 3, 6, 9, 12 months