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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Suicidal Ideation
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Behavioral: Experimental: Cognitive Behavior Therapy |
| Group B | Active comparator | Not 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.
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
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.
- First posted14 Oct 2021
- Study start1 Mar 2012
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Tracy Stecker, Medical University of South Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Treatment Seeking Among At-Risk Service Members Returning From Warzones
- ClinicalTrials.gov ID
- NCT05077514
- Acronym / sponsor ID
- 00053847
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 809 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Experimental: Cognitive Behavior Therapy |
| Group B | Active comparator | Behavioral: Active comparator: National Crisis Line |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- No suicide ideation or history of attempt
- currently receiving behavioral health treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Cognitive Behavior TherapyParticipants 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. | Behavioural | Group A |
| Active comparator: National Crisis LineParticipants assigned to Group B received information about the VA's National Crisis Line. | Behavioural | Group B |
Primary outcome
Change in attitudes towards behavioral health treatment
Time frame: 1 month after intervention
Change in mean score on the Perceptions about Services Scale (a measure of attitudes to treatment)
Initiation to behavioral health treatment
Time frame: 6 months
Number of participants who initiated behavioral health treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 36964422Stecker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.