Cognitive Therapy for Suicidal Older Men in Primary Care Settings

NCT00149773 | Completed Phase 1

• 3 other identifiers: P20MH071905-01802223DSIR 83-ATP
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting.

Conditions

Suicide, Attempted

Keywords

Cognitive therapy; Suicide; Older men; Death ideation; Primary care

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24

  1, 3, 6, 12, 18, and 24 months

Secondary Outcomes (3)

• Depression; measured at Months 1, 3, 6, 12, 18, and 24

  1, 3, 6, 12, 18, and 24 months

• Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24

  1, 3, 6, 12, 18, and 24 months

• Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24

  1, 3, 6, 12, 18, and 24 months

Study Arms (2)

Cognitive Therapy + Enriched Usual Care

EXPERIMENTAL

The cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include: 1. Using problem-solving and cognitive restructuring techniques to target hopelessness, reasons for living and dying, coping with loss, and perceived medical comorbidity that lead to suicidal ideation. 2. Improving social resources. 3. Improving adherence to medical regimen. 4. Targeting Suicidal Cognitions.

Behavioral: Cognitive Therapy

EnrichedUsual Care Condition

NO INTERVENTION

The Enriched Care (EC) condition will be used as the treatment comparison for this study. EC consists of usual care patients may obtain in the community as well as the assessment and referral services provided by the study case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health treatment in the community. The primary role of the study case manager is to establish a strong relationship with patients in order to retain the patients in the study for the duration of the study period.

Interventions

Cognitive Therapy BEHAVIORAL

Cognitive Therapy + Enriched Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently experiencing death ideation or suicidal ideation (total score greater than 0 on the Scale for Suicide Ideation)
• English-speaking
• Lives within the area served by the research unit
• Able to provide at least 2 verifiable contacts (typically family members)

You may not qualify if:

• Requires priority treatment for an acute, unstable, or severe Axis III disorder (e.g., dementia)
• Requires priority treatment for another debilitating problem (e.g., severe alcohol or drug dependence, mania, severe anorexia)
• Suffers from a psychotic disorder or psychotic thought processes
• Exhibits self-mutilating behavior without any intent to commit suicide (e.g., burning oneself with a cigarette)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Psychopathology Research Unit - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aaron T. Beck, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gregory K. Brown, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: May 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2011
• Last Updated: April 8, 2015

Record last verified: 2006-06

Locations

US (1)