Treatment Seeking Study

Increasing Treatment Seeking Among At-Risk Service Members Returning From Warzones

The study team conducted a randomized controlled clinical trial of 809 military service members who were at increased risk for suicide but not currently in behavioral health treatment. This study tested the effectiveness of a brief phone-based intervention (CBT-TS) aimed at changing military member's perceptions about behavioral health therapy. Participants completed five interviews over the course of one year to collect information about change in behavioral health symptoms and treatment utilization.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation
• Intervention / Treatment: Behavioral: Experimental: Cognitive Behavior Therapy; Behavioral: Active comparator: National Crisis Line

Detailed Description

Participants A randomized controlled trial design was used to test the efficacy of a brief, manualized, evidence-based CBT-TS to promote treatment initiation among at-risk military members and Veterans (W81XWH-13-2-0032; Increasing Treatment Seeking among At-Risk Service Members Returning from Warzones, funded by the Department of Defense). Participants were recruited through media advertisements. Ads targeted individuals who were considering help seeking. Eligible participants: 1) served in the US Armed Forces after September 11, 2001, 2) were not receiving behavioral health treatment at the time of the screening, and 3) endorsed recent suicidal ideation on the PHQ-9, item 9 (i.e., score of 1 or higher on the item) or a lifetime suicide attempt. Study procedures were reviewed and approved by the appropriate institutional review boards.

Procedures Individuals deemed eligible after screening and who agreed to participate went through the informed consent process and were randomly assigned to either the control or CBT-TS condition. Participants were administered the baseline assessment with follow-up symptom and treatment utilization assessments occurring at months 1, 3, 6, and 12. All assessments were administered by telephone. Participants were compensated $25 for each assessment.

Conditions:

Cognitive Behavioral Treatment for Treatment Seeking. CBT-TS is a brief, manualized, phone-delivered, individual session lasting 45-60 minutes. CBT-TS targets a change in beliefs that influence whether someone enters treatment. A CBT-TS session has 4 distinct, successive stages. First, participants identify current symptoms. Second, participants describe strategies to manage symptoms. Third, beliefs about treatment are elicited. Fourth, participants discuss each stated belief. All participants were administered the same structured intervention; however, content discussed was personalized. For example, while participants may endorse similar beliefs about getting help (e.g., "Going to treatment would mean I am weak"), their ideas surrounding that belief and the meaning of it may differ. Therefore, while the intervention was structured, it allows for a personalized, tailored approach.

Control condition. Participants assigned to the control condition did not receive the CBT-TS session. They were administered assessment measures at all time points comparable to the experimental group.

Measures Demographic variables were assessed at baseline using a structured questionnaire.

The Perceptions about Services Scale (PASS) was administered at baseline and is a 28-item self-report measure assessing beliefs about treatment and the extent to which they intend to initiate treatment. The PASS was originally developed to inform the development of the CBT-TS intervention and has good test-retest reliability.

Measures of suicidal ideation, history of suicide attempt, and a range of clinical risk factors for suicidal ideation and behavior were obtained at baseline assessment to describe the sample, to facilitate a comparison of the CBT-TS and control group, and to guide any statistical adjustments that may be needed in the event of differences between groups. Suicidal ideation and suicide attempt were measured with the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a widely used and validated semi-structured, rater-based interview designed to assess the severity and frequency of current and past suicidal ideation and behaviors. The C-SSRS has strong psychometric properties, has been validated for administration by phone, and has been used in prior research of suicidal behavior in Veterans. Clinical risk factors for suicidal thoughts and behavior were assessed using validated, widely used, brief, structured questionnaires including assessments of: the number of days of alcohol use (5+ drinks) and non-prescribed drug use in the past 30 days (Addiction Severity Index - Alcohol and Drug Scales [ASI];, pain, sleep disturbance (Insomnia Severity Index), thwarted belonging and perceived burdensomeness (Interpersonal Needs Questionnaire), depressive symptoms (Patient Health Questionnaire-9) and post-traumatic stress disorder symptoms (PTSD Checklist for DSM-IV Military Version2).

Treatment utilization was assessed at months 1, 3, 6 and 12. There were two primary outcomes, treatment initiation to address suicidality or related conditions and the number of treatment sessions attended. Treatment initiation was assessed by asking participants if they had attended a mental health appointment. Data were collected as to the nature of the appointment, reason for the visit, whether they reported seeing a physician, psychologist, or other professional, and whether the session occurred at a VA facility or outside of VA. The other primary outcome, treatment sessions attended, was assessed by asking participants how many mental health treatment sessions they had attended.

Logistic regression was used to assess treatment initiation, a categorical outcome. Latent growth curve modeling was conducted to assess treatment sessions attended, a continuous outcome.

• Study Type: Interventional
• Enrollment (Actual): 809
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Hanover, New Hampshire, United States, 03755
      • Dartmouth College
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be in US Military current or previous after September 11, 2001
• Must indicate suicidal ideation with in the past 2 weeks or have previous suicide attempt
• Not currently receiving behavioral health treatment

Exclusion Criteria:

• No suicide ideation or history of attempt
• currently receiving behavioral health treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A	Behavioral: Experimental: Cognitive Behavior Therapy; Participants assigned to Group A were asked to participate in a talking session with a psychologist regarding thoughts about treatment. This session is designed to explore thoughts about behavioral health therapy for suicidality. The session was administered by phone, initially and again one month later. Participants discussed current functioning and their thoughts about seeking help with the goal of modifying thoughts about treatment. This phone session lasted approximately 45 to 60 minutes.
ACTIVE_COMPARATOR: Group B	Behavioral: Active comparator: National Crisis Line; Participants assigned to Group B received information about the VA's National Crisis Line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attitudes towards behavioral health treatment	Change in mean score on the Perceptions about Services Scale (a measure of attitudes to treatment)	1 month after intervention
Initiation to behavioral health treatment	Number of participants who initiated behavioral health treatment	6 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2012
• Primary Completion (ACTUAL): January 14, 2019
• Study Completion (ACTUAL): January 14, 2019

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (ACTUAL): October 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 00053847; W81XWH-13-2-032 (OTHER_GRANT: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No