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Suicidal IdeationNCT05077514

Treatment Seeking Study

A study testing Experimental: Cognitive Behavior Therapy and Active comparator: National Crisis Line in people with Suicidal Ideation, run by Medical University of South Carolina at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 60 years
Conditions the study is for
Suicidal Ideation
What is being tested?
Experimental: Cognitive Behavior Therapy and Active comparator: National Crisis Line
Could I receive a placebo?
No, everyone receives an active treatment
How many people
809 participants
Where
2 sitesUnited States
Study dates
1 Mar 2012to 14 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Medical University of South Carolina

    Charleston, South Carolina, 29407

  • Dartmouth College

    Hanover, New Hampshire, 03755

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Experimental: Cognitive Behavior Therapy, Active comparator: National Crisis Line
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Cognitive Behavior TherapyBehavioural

    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 LineBehavioural

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

Study groups in NCT05077514
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Behavioral: Experimental: Cognitive Behavior Therapy
Group BActive comparatorNot described
Receives: Behavioral: Active comparator: National Crisis Line

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in attitudes towards behavioral health treatment

    Change in mean score on the Perceptions about Services Scale (a measure of attitudes to treatment)

    Measured: 1 month after intervention

  2. Initiation to behavioral health treatment

    Number of participants who initiated behavioral health treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start1 Mar 2012
  3. Primary completion14 Jan 2019
  4. Study completion14 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077514
Sponsor's protocol ID
00053847
Other IDs
W81XWH-13-2-032
Status last verified
Oct 2021
First submitted
1 Oct 2021
Last updated
21 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stecker T, Allan NP, Hoge C, Ashrafioun L, Conner KR. Efficacy of CBT for Treatment Seeking (CBT-TS) in Untreated Veterans and Service Members at Risk for Suicidal Behavior. J Gen Intern Med. 2023 Sep;38(12):2639-2646. doi: 10.1007/s11606-023-08129-z. Epub 2023 Mar 24.

    PubMed 36964422

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Cognitive Behavior Therapy and Active comparator: National Crisis Line in people with Suicidal Ideation, run by Medical University of South Carolina at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in attitudes towards behavioral health treatment (time frame: 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077514, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.

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