NCT01918696

Brief Summary

The purpose of this study is to determine whether a computerized intervention designed to reduce anger-provoking interpretation biases will reduce suicide risk among individuals with elevated levels of trait anger.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration 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

July 11, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2.9 years

First QC Date

July 11, 2013

Last Update Submit

January 26, 2021

Conditions

Keywords

suicideangerinterpretation modificationcomputerized treatment

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999)

    change from baseline at 1-month, 3-months, and 6-months

Secondary Outcomes (1)

  • Beck Suicide Scale (BSS; Beck et al., 1979)

    change from baseline at 1-month, 3-months, and 6-months

Other Outcomes (1)

  • Interpersonal Needs Questionnaire (INQ; Van Orden, Cukrowicz, Witte, & Joiner, 2012

    change from baseline at 1-month, 3-month, and 6-months

Study Arms (3)

Anger Reduction Treatment

EXPERIMENTAL

This treatment consists of eight 15-minute sessions. Participants will read scenarios and imagine themselves in these situations: "A driver does not let you over even though you have your blinker on." Next, another will appear to provide a less ambiguous interpretation. One letter will be missing from the key word of this sentence. The sentence will read "They can't s\_e you." The participant will fill in the missing letter (to form "see"). Next, this interpretation will be reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is the driver being disrespectful?"). In each session 64 training scenarios will be presented. Participants will never see the same scenario twice over the course of the study.

Behavioral: Anger Reduction Treatment

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Participants will receive eight 15-minute sessions of PMR. They will listen to a PMR script (Kassinove \& Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups. At the end of this procedure, participants will create a plan for when they will use the exercise. They will then type out the sentence: "When I feel \[write the feeling you decided on\], then I will use this relaxation technique." They will then be told, "Now, go over what you have written and say it quietly to yourself until you can repeat it word for word without having to read what you have written."

Behavioral: Progressive Muscle Relaxation

Control Condition

PLACEBO COMPARATOR

To control for expectancy effects, participants assigned to the control condition will complete eight computerized sessions consisting of psychoeducation on healthy behaviors. These sessions will be matched for time with the active conditions, lasting 15 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep, and will be taken from protocols developed from our ongoing research. This psychoeducation is perceived as credible but has no detectable impact on behavior. After the post-treatment session, participants will be provided with the active ART treatment free of charge if they wish to receive it.

Behavioral: Control Condition

Interventions

Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.

Anger Reduction Treatment

Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.

Progressive Muscle Relaxation

Eight 15-minute sessions of informative videos on healthy living.

Control Condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elevated levels of trait anger (scoring 19 or higher, or the top 25% of the general population)
  • must have access to a computer with an internet connection
  • must also be English speakers

You may not qualify if:

  • currently receiving therapy for problematic anger
  • evidence of serious suicidal intent requiring hospitalization or immediate treatment
  • evidence of psychotic-spectrum disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Suicidal IdeationSuicide

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jesse R Cougle, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2013

First Posted

August 8, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations