Treatment Seeking Study

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077514
• Other study ID #: 00053847
• Secondary ID: W81XWH-13-2-032
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: January 14, 2019

Study information

• Verified date: October 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

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: National Crisis Line
Participants assigned to Group B received information about the VA's National Crisis Line.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Dartmouth College	Hanover	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Initiation to behavioral health treatment	Number of participants who initiated behavioral health treatment	6 months