<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04490265</url>
  </required_header>
  <id_info>
    <org_study_id>5R56MH121555</org_study_id>
    <nct_id>NCT04490265</nct_id>
  </id_info>
  <brief_title>Suicide Prevention for Patients With Chronic Pain</brief_title>
  <official_title>Suicide Prevention for Patients With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Veterans BioMedical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Veterans BioMedical Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive&#xD;
      remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits&#xD;
      through self-report, objective neuropsychological assessment and caregiver report. We have&#xD;
      used an adaptive design so that if there is strong evidence for target engagement, we will&#xD;
      continue with the trial as a fully powered clinical trial (i.e., the end of the current&#xD;
      proposal will act as the interim assessment) to the determine the efficacy of remote PST for&#xD;
      patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every day, 120 people die from suicide, that is one person every 15 minutes.1 Suicide&#xD;
      prevention treatments focus on those at highest risk and are primarily delivered as mental&#xD;
      health treatments,2-5 and yet 70% of patients with suicide risk do not attend mental health&#xD;
      treatment. Developing treatment for patients not served by existing suicide prevention&#xD;
      programs will improve access to care and is necessary to stop suicide.&#xD;
&#xD;
      Patients with chronic pain in the US (100 million) have 2.6-times greater risk of suicide and&#xD;
      those on long-term opioid treatment are at even greater risk. Unfortunately, they often do&#xD;
      not receive mental health treatment and thus do not receive suicide prevention interventions.&#xD;
      They do receive frequent healthcare for their pain providing an unmet opportunity to&#xD;
      integrate suicide prevention into their treatment for pain.&#xD;
&#xD;
      Problem-solving treatment (PST) is an evidence-based approach that is available where&#xD;
      patients want to receive treatment (e.g., primary care) and is efficacious for chronic pain.&#xD;
      Importantly, PST targets problem-solving deficits which are known to increase risk of&#xD;
      suicide, suggesting PST could be leveraged to reduce suicide risk. Deficits in&#xD;
      problem-solving (an executive function of finding solutions to difficult issues) directly&#xD;
      increase suicidal risk because they keep patients with active suicidal ideation from&#xD;
      generating solutions to their problems (e.g., chronic pain), other than through suicide.&#xD;
      Deficits in problem-solving also make it difficult to keep pain from impairing daily&#xD;
      activities and social relationships. This indirectly increases suicide risk because&#xD;
      impairment in daily activities increases feelings of burdensomeness and impairment in social&#xD;
      relationships increases feelings of not belonging. Feelings of burdensomeness and of not&#xD;
      belonging are key theoretical pathways to suicidal behavior.&#xD;
&#xD;
      Working with our clinical partners and patients, we developed a 12-week remote delivered PST&#xD;
      for patients with chronic pain and moderate suicidal risk. The treatment addresses deficits&#xD;
      in problem-solving by teaching patients strategies to address problems caused by chronic pain&#xD;
      that increase risk of suicide (e.g., impairment in daily activities leading to feelings of&#xD;
      burdensomeness). Our preliminary data suggests that PST is feasible, acceptable and may be&#xD;
      efficacious. In a national survey we found 56% of patients with chronic pain and suicide risk&#xD;
      were interested in problem-solving treatment. In a clinical pilot we were able to engage&#xD;
      Veterans with chronic pain and suicide risk with 75% completing the treatment. Finally, in a&#xD;
      clinical trial that randomized patients to 12 sessions of PST or 12 sessions of health&#xD;
      education, we found that patients with chronic pain and moderate suicide risk (n=21)&#xD;
      randomized to PST had a reduction in suicidal ideation and problem-solving deficits&#xD;
      (self-report) as compared to health education.&#xD;
&#xD;
      The goal of the current proposal (R56) is to ensure PST is engaging problem-solving deficits.&#xD;
      Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive&#xD;
      remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits&#xD;
      through self-report, objective neuropsychological assessment and caregiver report. We have&#xD;
      used an adaptive design so that if there is strong evidence for target engagement, we will&#xD;
      continue with the trial as a fully powered clinical trial (i.e., the end of the current&#xD;
      proposal will act as the interim assessment) to the determine the efficacy of remote PST for&#xD;
      patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.&#xD;
&#xD;
      Aim 1: Estimate the effect of remote-delivered PST on targets. We hypothesize that PST&#xD;
      reduces our primary target, problem-solving deficits as assessed through (H1) self-report,&#xD;
      (H2) objective neuropsychological assessment, (H3) caregiver report, as compared to&#xD;
      supportive psychotherapy. We hypothesize that PST reduces our secondary targets (H1) feelings&#xD;
      of burdensomeness and (H2) feelings of not belonging, as compared to supportive&#xD;
      psychotherapy.&#xD;
&#xD;
      Exploratory Aim 2: Explore the effect size of PST as compared to supportive psychotherapy on&#xD;
      suicide outcomes (intensity of suicidal ideation, difficulties coping with suicidal ideation)&#xD;
      and chronic pain outcomes ((H4) chronic pain, (H5) pain related disability).&#xD;
&#xD;
      Our previous preliminary data suggests that PST is feasible, acceptable and may be&#xD;
      efficacious. The goal of the current proposal (R56) is to confirm PST is engaging&#xD;
      problem-solving deficits (measured through self-report and objective measures). Deliverable:&#xD;
      At the end of the proposed trial, we will have the necessary information (in combination with&#xD;
      our previous preliminary data) to inform a go/no-go decision on converting the current&#xD;
      proposal into a fully powered clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social problem-solving inventory - patient report</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score. Scores range from 0-100 with higher scores equaling better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social problem-solving inventory - patient report</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social problem-solving inventory - caregiver report</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social problem-solving inventory - caregiver report</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Go No Go</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Measures attention and impulse inhibition. Inhibiting impulses is a key component of preventing impulsive behavior that can lead to suicide. Indeed the Go no/go has been shown to predict suicidal behavior and our preliminary data suggests it is responsive to treatment for Veterans with chronic pain and suicidal ideation. We will use the emotional go no go. Raw score correct range = 0 - 360</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Means End Problem-Solving Task</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>The Means End Problem-Solving Task consists of a series of scenarios, with each one identifying the beginning and end of a story. The subject's task is to come up with the middle of the story. Stories are scored according to how many steps to reaching the end the patient identifies. This instrument captures a crucial element of problem-solving: identifying the steps (i.e., means) that will lead to goal attainment (i.e., end). This aspect of problem-solving is directly relevant to patients with pain whose limited set of identified means includes suicide. An increase in effective means generated is expected to drive reduction in suicide ideation. The measure has been used in suicide research and has shown that suicide attempters generate fewer relevant means than both non-suicidal psychiatric controls and non-psychiatric controls. Scores range from 0-1 with higher=better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iowa Gambling Task</measure>
    <time_frame>Change from Baseline to 12-weeks</time_frame>
    <description>The Iowa gambling task is a neuropsychological task of problem-solving. The participgoal of the task is to make money. Participants are presented four decks of cards and have to choose the best deck to make money. The Iowa gambling task has been shown to change after problem-solving therapy. Scores range from -100 to 100 with higher equaling better problem-solving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Stroop</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>The emotional Stroop is a test of response inhibition, a critical skill to stop suicidal behavior. Scores range from 0-125 with higher scores equaling better problem-solving</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Needs Questionnaire</measure>
    <time_frame>Change from Baseline to 12 weeks.. The belonging subscale is 6 items and scores range from 0-42 with higher scores indicating less belonging, the burdensomeness subscale is 9 items with higher scores indicating greater burdensomeness.</time_frame>
    <description>Feelings of burdensomeness and belongingness will be measured by the Interpersonal Needs Questionnaire (INQ). This measure is 18-item self-report questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicide Ideation Questionnaire (SIQ).</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicide Ideation Questionnaire (SIQ).</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicide-Related Coping Scale</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., &quot;I recognize the circumstances that make me suicidal&quot;). Scores range from 0-68 with higher scores indicating better coping.</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicide-Related Coping Scale</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., &quot;I recognize the circumstances that make me suicidal&quot;). Scores range from 0-68 with higher scores indicating better coping.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Disability Index (PDI)</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain. The PDI ranges from 0-70 with higher scores indicating worse disability from pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Disability Index (PDI)</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain.The PDI ranges from 0-70 with higher scores indicating worse disability from pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Pain Inventory (BPI)</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Pain Inventory (BPI)</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Suicide</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Problem-Solving Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Psychotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week (&quot;A time when I felt stressed was …&quot; ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-solving treatment</intervention_name>
    <description>included in arm descriptions</description>
    <arm_group_label>Problem-Solving Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive Psychotherapy</intervention_name>
    <description>included in arm descriptions</description>
    <arm_group_label>Supportive Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria will include:&#xD;
&#xD;
          -  has a VA primary care provider and has had an in-person visit with a VA provider in&#xD;
             the past year;&#xD;
&#xD;
          -  pain that is (b1) musculoskeletal, defined as regional (joints, limbs, back, neck) or&#xD;
             more generalized (chronic widespread pain);&#xD;
&#xD;
          -  pain that is (b2) moderately severe, defined as a Brief Pain Inventory (BPI) intensity&#xD;
             item score of 5 or higher for either &quot;average&quot; or &quot;worst&quot; pain in the past week;&#xD;
&#xD;
          -  pain that is (b3) persistent, (i.e., ≥3 months)&#xD;
&#xD;
          -  active suicidal ideation defined as scoring a 2 to 4 on the C-SSRS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  life-threatening condition&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  psychotic disorder&#xD;
&#xD;
          -  pregnant or plans to become pregnant in the next year&#xD;
&#xD;
          -  suicide attempt in the past year or hospitalization for suicide risk in the past year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa M McAndrew, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA NJHCS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa M McAndrew, PhD</last_name>
    <phone>973-676-1000</phone>
    <phone_ext>1167</phone_ext>
    <email>lisa.mcandrew@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicole Anastasides, MS</last_name>
    <phone>973-676-1000</phone>
    <phone_ext>1167</phone_ext>
    <email>nicole.anastasides@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA NJHCS</name>
      <address>
        <city>East Orange</city>
        <state>New Jersey</state>
        <zip>07018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Anastasides, MS</last_name>
      <phone>973-676-1000</phone>
      <phone_ext>1167</phone_ext>
      <email>nicole.anastasides@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>If the subject agrees, their data will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many National Institute of Mental Health (NIMH) studies is stored and managed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Every 3 months data is uploaded</ipd_time_frame>
    <ipd_url>http://nda.nih.gov</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04490265
org study id: 5R56MH121555
nct id: NCT04490265
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive
      remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits
      through self-report, objective neuropsychological assessment and caregiver report. We have
      used an adaptive design so that if there is strong evidence for target engagement, we will
      continue with the trial as a fully powered clinical trial (i.e., the end of the current
      proposal will act as the interim assessment) to the determine the efficacy of remote PST for
      patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.
Every day, 120 people die from suicide, that is one person every 15 minutes.1 Suicide
      prevention treatments focus on those at highest risk and are primarily delivered as mental
      health treatments,2-5 and yet 70% of patients with suicide risk do not attend mental health
      treatment. Developing treatment for patients not served by existing suicide prevention
      programs will improve access to care and is necessary to stop suicide.

      Patients with chronic pain in the US (100 million) have 2.6-times greater risk of suicide and
      those on long-term opioid treatment are at even greater risk. Unfortunately, they often do
      not receive mental health treatment and thus do not receive suicide prevention interventions.
      They do receive frequent healthcare for their pain providing an unmet opportunity to
      integrate suicide prevention into their treatment for pain.

      Problem-solving treatment (PST) is an evidence-based approach that is available where
      patients want to receive treatment (e.g., primary care) and is efficacious for chronic pain.
      Importantly, PST targets problem-solving deficits which are known to increase risk of
      suicide, suggesting PST could be leveraged to reduce suicide risk. Deficits in
      problem-solving (an executive function of finding solutions to difficult issues) directly
      increase suicidal risk because they keep patients with active suicidal ideation from
      generating solutions to their problems (e.g., chronic pain), other than through suicide.
      Deficits in problem-solving also make it difficult to keep pain from impairing daily
      activities and social relationships. This indirectly increases suicide risk because
      impairment in daily activities increases feelings of burdensomeness and impairment in social
      relationships increases feelings of not belonging. Feelings of burdensomeness and of not
      belonging are key theoretical pathways to suicidal behavior.

      Working with our clinical partners and patients, we developed a 12-week remote delivered PST
      for patients with chronic pain and moderate suicidal risk. The treatment addresses deficits
      in problem-solving by teaching patients strategies to address problems caused by chronic pain
      that increase risk of suicide (e.g., impairment in daily activities leading to feelings of
      burdensomeness). Our preliminary data suggests that PST is feasible, acceptable and may be
      efficacious. In a national survey we found 56% of patients with chronic pain and suicide risk
      were interested in problem-solving treatment. In a clinical pilot we were able to engage
      Veterans with chronic pain and suicide risk with 75% completing the treatment. Finally, in a
      clinical trial that randomized patients to 12 sessions of PST or 12 sessions of health
      education, we found that patients with chronic pain and moderate suicide risk (n=21)
      randomized to PST had a reduction in suicidal ideation and problem-solving deficits
      (self-report) as compared to health education.

      The goal of the current proposal (R56) is to ensure PST is engaging problem-solving deficits.
      Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive
      remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits
      through self-report, objective neuropsychological assessment and caregiver report. We have
      used an adaptive design so that if there is strong evidence for target engagement, we will
      continue with the trial as a fully powered clinical trial (i.e., the end of the current
      proposal will act as the interim assessment) to the determine the efficacy of remote PST for
      patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.

      Aim 1: Estimate the effect of remote-delivered PST on targets. We hypothesize that PST
      reduces our primary target, problem-solving deficits as assessed through (H1) self-report,
      (H2) objective neuropsychological assessment, (H3) caregiver report, as compared to
      supportive psychotherapy. We hypothesize that PST reduces our secondary targets (H1) feelings
      of burdensomeness and (H2) feelings of not belonging, as compared to supportive
      psychotherapy.

      Exploratory Aim 2: Explore the effect size of PST as compared to supportive psychotherapy on
      suicide outcomes (intensity of suicidal ideation, difficulties coping with suicidal ideation)
      and chronic pain outcomes ((H4) chronic pain, (H5) pain related disability).

      Our previous preliminary data suggests that PST is feasible, acceptable and may be
      efficacious. The goal of the current proposal (R56) is to confirm PST is engaging
      problem-solving deficits (measured through self-report and objective measures). Deliverable:
      At the end of the proposed trial, we will have the necessary information (in combination with
      our previous preliminary data) to inform a go/no-go decision on converting the current
      proposal into a fully powered clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Social problem-solving inventory - patient report
time frame: Change from Baseline to 12 weeks
description: The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score. Scores range from 0-100 with higher scores equaling better problem-solving.
measure: Social problem-solving inventory - patient report
time frame: Change from Baseline to 6 months
description: The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.
measure: Social problem-solving inventory - caregiver report
time frame: Change from Baseline to 12 weeks
description: The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.
measure: Social problem-solving inventory - caregiver report
time frame: Change from Baseline to 6 months
description: The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.
measure: Emotional Go No Go
time frame: Change from Baseline to 12 weeks
description: Measures attention and impulse inhibition. Inhibiting impulses is a key component of preventing impulsive behavior that can lead to suicide. Indeed the Go no/go has been shown to predict suicidal behavior and our preliminary data suggests it is responsive to treatment for Veterans with chronic pain and suicidal ideation. We will use the emotional go no go. Raw score correct range = 0 - 360
measure: Means End Problem-Solving Task
time frame: Change from Baseline to 12 weeks
description: The Means End Problem-Solving Task consists of a series of scenarios, with each one identifying the beginning and end of a story. The subject's task is to come up with the middle of the story. Stories are scored according to how many steps to reaching the end the patient identifies. This instrument captures a crucial element of problem-solving: identifying the steps (i.e., means) that will lead to goal attainment (i.e., end). This aspect of problem-solving is directly relevant to patients with pain whose limited set of identified means includes suicide. An increase in effective means generated is expected to drive reduction in suicide ideation. The measure has been used in suicide research and has shown that suicide attempters generate fewer relevant means than both non-suicidal psychiatric controls and non-psychiatric controls. Scores range from 0-1 with higher=better problem-solving.
measure: Iowa Gambling Task
time frame: Change from Baseline to 12-weeks
description: The Iowa gambling task is a neuropsychological task of problem-solving. The participgoal of the task is to make money. Participants are presented four decks of cards and have to choose the best deck to make money. The Iowa gambling task has been shown to change after problem-solving therapy. Scores range from -100 to 100 with higher equaling better problem-solving.
measure: Emotional Stroop
time frame: Change from Baseline to 12 weeks
description: The emotional Stroop is a test of response inhibition, a critical skill to stop suicidal behavior. Scores range from 0-125 with higher scores equaling better problem-solving
measure: Interpersonal Needs Questionnaire
time frame: Change from Baseline to 12 weeks.. The belonging subscale is 6 items and scores range from 0-42 with higher scores indicating less belonging, the burdensomeness subscale is 9 items with higher scores indicating greater burdensomeness.
description: Feelings of burdensomeness and belongingness will be measured by the Interpersonal Needs Questionnaire (INQ). This measure is 18-item self-report questionnaire.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Change from Baseline to 12 weeks
description: Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Change from Baseline to 6 months
description: Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.
measure: Suicide Ideation Questionnaire (SIQ).
time frame: Change from Baseline to 12 weeks
description: Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.
measure: Suicide Ideation Questionnaire (SIQ).
time frame: Change from Baseline to 6 months
description: Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.
measure: Suicide-Related Coping Scale
time frame: Change from Baseline to 12 weeks
description: The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.
measure: Suicide-Related Coping Scale
time frame: Change from Baseline to 6 months
description: The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.
measure: Pain Disability Index (PDI)
time frame: Change from Baseline to 12 weeks
description: Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain. The PDI ranges from 0-70 with higher scores indicating worse disability from pain.
measure: Pain Disability Index (PDI)
time frame: Change from Baseline to 6 months
description: Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain.The PDI ranges from 0-70 with higher scores indicating worse disability from pain.
measure: Brief Pain Inventory (BPI)
time frame: Change from Baseline to 12 weeks
description: Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.
measure: Brief Pain Inventory (BPI)
time frame: Change from Baseline to 6 months
description: Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.
arm group label: Problem-Solving Treatment
arm group type: Experimental
description: Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring.
arm group label: Supportive Psychotherapy
arm group type: Placebo Comparator
description: Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video.
intervention type: Behavioral
intervention name: Problem-solving treatment
description: included in arm descriptions
arm group label: Problem-Solving Treatment
intervention type: Behavioral
intervention name: Supportive Psychotherapy
description: included in arm descriptions
arm group label: Supportive Psychotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lisa M McAndrew, PhD
role: Principal Investigator
affiliation: VA NJHCS
last name: Lisa M McAndrew, PhD
phone: 973-676-1000
phone ext: 1167
email: lisa.mcandrew@va.gov
last name: Nicole Anastasides, MS
phone: 973-676-1000
phone ext: 1167
email: nicole.anastasides@va.gov
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: Yes
ipd description: If the subject agrees, their data will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many National Institute of Mental Health (NIMH) studies is stored and managed.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Every 3 months data is uploaded
ipd url: http://nda.nih.gov