NCT01535482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

5.6 years

First QC Date

August 25, 2011

Last Update Submit

June 7, 2017

Conditions

Suicide, Attempted

Keywords

Cognitive therapySuicideOlder mensuicide ideation

Outcome Measures

Primary Outcomes (1)

  • Change in baseline suicidal ideation

    baseline, 1, 3, 6, 9, 12 months

Secondary Outcomes (8)

  • depression

    baseline, 1, 3, 6, 9, 12 months

  • hopelessness

    baseline, 1, 3, 6, 9, 12 months

  • quality of life

    baseline, 1, 3, 6, 9, 12 months

  • social problem solving skills

    baseline, 1, 3, 6, 9, 12 months

  • complicated grief

    baseline, 1, 3, 6, 9, 12 months

  • +3 more secondary outcomes

Study Arms (2)

Cognitive Therapy

EXPERIMENTAL

A cognitive therapy protocol specifically designed to target suicidal ideation in older adults.

Behavioral: Cognitive Therapy

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Cognitive TherapyBEHAVIORAL

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

Cognitive Therapy
Enhanced Usual CareBEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aaron T. Beck Psychopathology Research Center - University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2011

First Posted

February 17, 2012

Study Start

September 1, 2011

Primary Completion

April 6, 2017

Study Completion

April 6, 2017

Last Updated

June 8, 2017

Record last verified: 2017-06

Locations

US(1)