Clinical trial NCT01535482: Cognitive Therapy for Suicidal Older Men
Official title: Cognitive Therapy for Suicidal Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Cognitive therapy
Suicide
Older men
suicide ideation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-02-17
Enrollment: 110
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change in baseline suicidal ideation
timeFrame: baseline, 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: depression
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: hopelessness
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: quality of life
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: social problem solving skills
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: complicated grief
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: reasons for living and dying
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: perceived social support
timeFrame: baseline, 1, 3, 6, 9, 12 months
measure: Cognitive Executive Functioning
timeFrame: baseline, 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
state: Pennsylvania
Study officials:
References: