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Completed

NCT Number: NCT01535482

Cognitive Therapy for Suicidal Older Men

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aaron T. Beck Psychopathology Research Center - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Male
  • 50 years of age or older
  • Able to speak English
  • Able to provide written informed consent
  • Able to attend study assessment and therapy sessions
  • Able to provide at least two verifiable contacts for tracking purposes
  • 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

  • Needed priority treatment for a substance use disorder as determined by the referring clinician.
  • Needed priority treatment for PTSD as determined by the referring clinician.
  • 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.

Treatment and study plan

cognitive therapy

Behavioral

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

Enhanced Usual Care

Behavioral

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.

Primary outcomes

  1. Change in baseline suicidal ideation

    Time frame: baseline, 1, 3, 6, 9, 12 months

Secondary outcomes

  1. depression

    Time frame: baseline, 1, 3, 6, 9, 12 months

  2. hopelessness

    Time frame: baseline, 1, 3, 6, 9, 12 months

  3. quality of life

    Time frame: baseline, 1, 3, 6, 9, 12 months

  4. social problem solving skills

    Time frame: baseline, 1, 3, 6, 9, 12 months

  5. complicated grief

    Time frame: baseline, 1, 3, 6, 9, 12 months

  6. reasons for living and dying

    Time frame: baseline, 1, 3, 6, 9, 12 months

  7. perceived social support

    Time frame: baseline, 1, 3, 6, 9, 12 months

  8. Cognitive Executive Functioning

    Time frame: baseline, 1, 3, 6, 9, 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2012
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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