<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/NCT03760731</url>
  </required_header>
  <id_info>
    <org_study_id>D2854-R</org_study_id>
    <secondary_id>1I01RX002854-01A1</secondary_id>
    <nct_id>NCT03760731</nct_id>
  </id_info>
  <brief_title>Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans</brief_title>
  <official_title>Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The need for moral injury interventions is increasingly being recognized as a domain in&#xD;
      Veteran care that must be addressed. Consequences of exposure to morally injurious events&#xD;
      include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression.&#xD;
      Exposure to morally injurious events is also highly prevalent among Veterans. Thus,&#xD;
      interventions addressing moral injury are crucial to helping Veterans build meaningful lives.&#xD;
      Psychotherapies explicitly targeting moral injury and functional recovery associated with&#xD;
      this construct are limited in VHA. The proposed study serves as a first step in addressing&#xD;
      this gap in the literature through the development of a recovery-oriented, evidence-based&#xD;
      treatment approach for moral injury among warzone Veterans who report functional impairments&#xD;
      related to moral emotions. The proposed pilot study will evaluate the acceptability of this&#xD;
      intervention and the feasibility of the design for a future study to test the treatment's&#xD;
      capacity to improve patients' functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Warzone Veterans exposed to morally injurious events frequently experience numerous&#xD;
      difficulties in functioning. These Veterans often report suicidal ideation and behavior,&#xD;
      substance abuse, symptoms of depression and PTSD, and problems in resuming valued living&#xD;
      (e.g., spiritual practice, close relationships). Despite the transdiagnostic nature of moral&#xD;
      injury, there are no moral injury-specific transdiagnostic interventions. Existing&#xD;
      interventions tend to be focused on treating moral injury in the context of PTSD. In addition&#xD;
      to an emphasis on PTSD, these interventions target beliefs associated with moral injury as&#xD;
      causal factors in the development and maintenance of suffering. An emphasis on altering&#xD;
      beliefs associated with moral injury may not optimally facilitate functional recovery as&#xD;
      moral pain from moral violations may be justified. As one third of warzone Veterans endorse&#xD;
      exposure to morally injurious events, it is vital to develop interventions that can be&#xD;
      efficiently disseminated in VHA to facilitate functional recovery. The ideal intervention&#xD;
      must simultaneously address moral emotions and promote values consistent behavior in the face&#xD;
      of these emotions.&#xD;
&#xD;
      Acceptance and Commitment Therapy for moral injury (ACT-MI) is a recovery-based, psychosocial&#xD;
      treatment ideally suited for Veterans endorsing difficulties in functioning related to moral&#xD;
      injury. ACT teaches skills to help Veterans relate differently to painful thoughts, emotions,&#xD;
      urges, and sensations. Rather than focusing on symptom reduction, ACT is an evidence-based&#xD;
      intervention that directly targets functional recovery by assisting Veterans in identifying&#xD;
      and engaging in values-consistent behavior even in the presence of distress. In Veteran&#xD;
      populations specifically, ACT has been demonstrated effective in treating suicidal ideation&#xD;
      and depression and as a result, has been &quot;rolled-out&quot; as an evidence based psychotherapy for&#xD;
      depression within VHA. ACT-MI operates on the principles of ACT, with an explicit focus on&#xD;
      the social functions of moral emotions. ACT-MI is the only intervention for moral injury that&#xD;
      is based on social functionalism which purports that moral emotions (e.g., shame, pride)&#xD;
      serve evolutionary purposes essential to group survival. Thus learning to interact with moral&#xD;
      emotions differently is crucial to recovery. In ACT-MI, a group-based intervention is used to&#xD;
      facilitate in-vivo exposure to moral emotions in the context of values. The proposed two arm&#xD;
      randomized controlled pilot study will evaluate the acceptability of ACT-MI and an active&#xD;
      control treatment, and determine the feasibility of the randomized controlled trial design&#xD;
      for a future full-scale efficacy study. To accomplish this goal the investigators will&#xD;
      continue to refine ACT-MI. Veterans enrolled will be randomized to: (a) Present Centered&#xD;
      Therapy (PCT) or (b) ACT-MI, both of which will consist of 12, 90-minute group sessions. The&#xD;
      specific aims of this study are to: (1) Evaluate the acceptability of the ACT-MI intervention&#xD;
      for Veterans experiencing impairment in functioning associated with moral injury, (2)&#xD;
      Determine the feasibility of the efficacy study design, and to (3) Select measures and&#xD;
      calculate the necessary sample size for a future efficacy study. The performance of validated&#xD;
      scales will be measured, in addition to selected NIH Patient Reported Outcomes Measurement&#xD;
      Information System modules. All participants will complete a baseline assessment, post&#xD;
      treatment, and follow-up assessment one and three months after completion of ACT-MI or PCT.&#xD;
      Participants in both groups will also complete a post-treatment assessment on the&#xD;
      acceptability of the intervention. The proposed study represents a crucial first step in a&#xD;
      line of research likely to yield a recovery oriented, empirically-supported intervention for&#xD;
      moral injury among Veterans. The objectives of ACT-MI directly align with Rehabilitation&#xD;
      Research and Development's goal to improve Veteran functioning, increase community&#xD;
      reintegration, and to facilitate Veteran centered care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.&#xD;
Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor will be blind to treatment condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>Post-treatment (0-7 days after treatment completion)</time_frame>
    <description>The investigators will assess the proportion of participants who find ACT-MI acceptable, defined as 70% of participants scoring 24 on the Client Satisfaction Questionnaire (CSQ). The total for the CSQ can range from 8- to 32-points. Higher scores on the CSQ indicate greater treatment acceptability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Narrative Evaluation of Intervention Interview</measure>
    <time_frame>Post-treatment (0-7 days after treatment completion)</time_frame>
    <description>The Narrative Evaluation of Intervention Interview (NEII) will be used to inform any necessary revisions to the intervention and refinement of the treatment manual. The NEII is a semi-structured qualitative interview assessing the perspective of each participant about the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. The NEII will be used to assess acceptability and inform revisions to the treatment manuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for Termination (Client and Therapist Versions)</measure>
    <time_frame>Post-treatment (0-7 days after terminating treatment)</time_frame>
    <description>The Reasons for Termination scale is a self-report measure which assesses the impact of common reasons patients terminate therapy. The scale will be used to assess treatment acceptability. Participants who terminate treatment early and their therapists will be asked to independently rate their reasons for termination in 19 domains. Possible total scores on this scale range from 10 to 190-points. Higher scores indicate that the reason for termination had a very great influence on the participant's termination of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Valued Living Questionnaire</measure>
    <time_frame>Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up</time_frame>
    <description>The Valued Living Questionnaire is a self-report measure that assesses participants' values as well as the consistency with which they believe they have been living life according to their values. This scale will be examined as a candidate outcome measure for a future efficacy trial. A possible of 10 to 100 total points for importance of values and 10 to 100 total points for consistency of action with values is demonstrated on the Valued Living Questionnaire (VLQ). Higher scores on the VLQ are indicative of greater importance of values and greater consistency in acting on values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome Questionnaire-45 (OQ-45)</measure>
    <time_frame>Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up</time_frame>
    <description>The Outcome Questionnaire-45 (OQ-45) is a self-report measure that assesses functioning in the psychosocial domains of symptom distress (0-100 points), social relations (0-44 points), and social role functioning (0-36 points). The OQ-45 will be examined as a candidate outcome measure for a future efficacy trial. Higher scores on the OQ-45 are indicative of more symptom distress, difficulty in social relations, and difficulty in social role functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a</measure>
    <time_frame>Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up</time_frame>
    <description>This is a self-report measure that assesses ability to perform various social activities. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 8 to 40 points on this scale with higher scores associated with greater satisfaction with social roles and activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS v2.0-Social Isolation</measure>
    <time_frame>Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up</time_frame>
    <description>This is a self-report measure that assesses experience of social isolation. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 4 to 20 points with higher scores on this scale associated with greater social isolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ecological Momentary Assessment</measure>
    <time_frame>Pre-treatment (Up to 30-days before starting treatment for a 1-week period) and post-treatment (0-7 days after treatment completion for a 1-week period)</time_frame>
    <description>Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance (1 to 5 point rating for experiential avoidance during the assessment period [7 possible items with 2 to 3 administered during each assessment period], higher scores indicate more experiential avoidance), emotions (1 to 5 point rating for each emotion during the assessment period [13 possible items with 2 administered from each category-negative self-directed emotions, negative other-directed emotions, and positive emotions-during each assessment period], higher scores indicate feeling the emotion at an extreme level), and engagement in valued behavior (identify the number of domains from 0 to 10 areas in which they have engaged in the assessment period; qualitative information gathered via audio recording).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Moral Injury</condition>
  <arm_group>
    <arm_group_label>Acceptance and Commitment Therapy for Moral Injury (ACT-MI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Present Centered Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right. PCT could provide another treatment option that might be preferable to some Veterans and promote patient choice. Additionally, PCT would require less clinician training and specialization than ACT-MI. Using PCT as an active comparison condition will determine whether it is necessary to train clinicians in ACT-MI or if therapists with exposure to supportive problem-solving therapy approaches can lead a group that impacts functioning among Veterans reporting moral injury-related distress.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy for Moral Injury (ACT-MI)</intervention_name>
    <description>Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.</description>
    <arm_group_label>Acceptance and Commitment Therapy for Moral Injury (ACT-MI)</arm_group_label>
    <other_name>ACT-MI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Present Centered Therapy (PCT)</intervention_name>
    <description>Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right.</description>
    <arm_group_label>Present Centered Therapy</arm_group_label>
    <other_name>PCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for VHA care&#xD;
&#xD;
          -  Has been deployed to a warzone&#xD;
&#xD;
          -  Has experienced a morally injurious event which continues to interfere with&#xD;
             functioning&#xD;
&#xD;
          -  Willing to be randomized and participate in either of the two conditions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Inability to complete study measures, e.g.:&#xD;
&#xD;
               -  due to significant acute intoxication/withdrawal symptoms&#xD;
&#xD;
               -  mania&#xD;
&#xD;
               -  psychosis&#xD;
&#xD;
               -  aggression&#xD;
&#xD;
               -  catatonia&#xD;
&#xD;
               -  cognitive impairment&#xD;
&#xD;
          -  Imminent suicide risk&#xD;
&#xD;
          -  Membership in a vulnerable population, e.g.:&#xD;
&#xD;
               -  pregnant women&#xD;
&#xD;
          -  History of significant violence towards VA staff&#xD;
&#xD;
          -  Participation in another psychotherapy research study&#xD;
&#xD;
          -  Current participation in an EBP for a condition related to moral injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren Borges, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rocky Mountain Regional VA Medical Center, Aurora, CO</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Borges, PhD</last_name>
    <phone>(314) 566-4118</phone>
    <email>lauren.borges2@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sean M Barnes, PhD</last_name>
    <phone>(303) 399-8020</phone>
    <phone_ext>4237</phone_ext>
    <email>Sean.Barnes2@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rocky Mountain Regional VA Medical Center, Aurora, CO</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Borges, PhD</last_name>
      <phone>314-566-4118</phone>
      <email>lauren.borges2@va.gov</email>
    </contact>
    <investigator>
      <last_name>Lauren Borges, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychosocial Rehabilitation</keyword>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03760731
org study id: D2854-R
secondary id: 1I01RX002854-01A1
nct id: NCT03760731
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The need for moral injury interventions is increasingly being recognized as a domain in
      Veteran care that must be addressed. Consequences of exposure to morally injurious events
      include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression.
      Exposure to morally injurious events is also highly prevalent among Veterans. Thus,
      interventions addressing moral injury are crucial to helping Veterans build meaningful lives.
      Psychotherapies explicitly targeting moral injury and functional recovery associated with
      this construct are limited in VHA. The proposed study serves as a first step in addressing
      this gap in the literature through the development of a recovery-oriented, evidence-based
      treatment approach for moral injury among warzone Veterans who report functional impairments
      related to moral emotions. The proposed pilot study will evaluate the acceptability of this
      intervention and the feasibility of the design for a future study to test the treatment's
      capacity to improve patients' functioning.
Warzone Veterans exposed to morally injurious events frequently experience numerous
      difficulties in functioning. These Veterans often report suicidal ideation and behavior,
      substance abuse, symptoms of depression and PTSD, and problems in resuming valued living
      (e.g., spiritual practice, close relationships). Despite the transdiagnostic nature of moral
      injury, there are no moral injury-specific transdiagnostic interventions. Existing
      interventions tend to be focused on treating moral injury in the context of PTSD. In addition
      to an emphasis on PTSD, these interventions target beliefs associated with moral injury as
      causal factors in the development and maintenance of suffering. An emphasis on altering
      beliefs associated with moral injury may not optimally facilitate functional recovery as
      moral pain from moral violations may be justified. As one third of warzone Veterans endorse
      exposure to morally injurious events, it is vital to develop interventions that can be
      efficiently disseminated in VHA to facilitate functional recovery. The ideal intervention
      must simultaneously address moral emotions and promote values consistent behavior in the face
      of these emotions.

      Acceptance and Commitment Therapy for moral injury (ACT-MI) is a recovery-based, psychosocial
      treatment ideally suited for Veterans endorsing difficulties in functioning related to moral
      injury. ACT teaches skills to help Veterans relate differently to painful thoughts, emotions,
      urges, and sensations. Rather than focusing on symptom reduction, ACT is an evidence-based
      intervention that directly targets functional recovery by assisting Veterans in identifying
      and engaging in values-consistent behavior even in the presence of distress. In Veteran
      populations specifically, ACT has been demonstrated effective in treating suicidal ideation
      and depression and as a result, has been "rolled-out" as an evidence based psychotherapy for
      depression within VHA. ACT-MI operates on the principles of ACT, with an explicit focus on
      the social functions of moral emotions. ACT-MI is the only intervention for moral injury that
      is based on social functionalism which purports that moral emotions (e.g., shame, pride)
      serve evolutionary purposes essential to group survival. Thus learning to interact with moral
      emotions differently is crucial to recovery. In ACT-MI, a group-based intervention is used to
      facilitate in-vivo exposure to moral emotions in the context of values. The proposed two arm
      randomized controlled pilot study will evaluate the acceptability of ACT-MI and an active
      control treatment, and determine the feasibility of the randomized controlled trial design
      for a future full-scale efficacy study. To accomplish this goal the investigators will
      continue to refine ACT-MI. Veterans enrolled will be randomized to: (a) Present Centered
      Therapy (PCT) or (b) ACT-MI, both of which will consist of 12, 90-minute group sessions. The
      specific aims of this study are to: (1) Evaluate the acceptability of the ACT-MI intervention
      for Veterans experiencing impairment in functioning associated with moral injury, (2)
      Determine the feasibility of the efficacy study design, and to (3) Select measures and
      calculate the necessary sample size for a future efficacy study. The performance of validated
      scales will be measured, in addition to selected NIH Patient Reported Outcomes Measurement
      Information System modules. All participants will complete a baseline assessment, post
      treatment, and follow-up assessment one and three months after completion of ACT-MI or PCT.
      Participants in both groups will also complete a post-treatment assessment on the
      acceptability of the intervention. The proposed study represents a crucial first step in a
      line of research likely to yield a recovery oriented, empirically-supported intervention for
      moral injury among Veterans. The objectives of ACT-MI directly align with Rehabilitation
      Research and Development's goal to improve Veteran functioning, increase community
      reintegration, and to facilitate Veteran centered care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor will be blind to treatment condition.
measure: Client Satisfaction Questionnaire
time frame: Post-treatment (0-7 days after treatment completion)
description: The investigators will assess the proportion of participants who find ACT-MI acceptable, defined as 70% of participants scoring 24 on the Client Satisfaction Questionnaire (CSQ). The total for the CSQ can range from 8- to 32-points. Higher scores on the CSQ indicate greater treatment acceptability.
measure: Narrative Evaluation of Intervention Interview
time frame: Post-treatment (0-7 days after treatment completion)
description: The Narrative Evaluation of Intervention Interview (NEII) will be used to inform any necessary revisions to the intervention and refinement of the treatment manual. The NEII is a semi-structured qualitative interview assessing the perspective of each participant about the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. The NEII will be used to assess acceptability and inform revisions to the treatment manuals.
measure: Reasons for Termination (Client and Therapist Versions)
time frame: Post-treatment (0-7 days after terminating treatment)
description: The Reasons for Termination scale is a self-report measure which assesses the impact of common reasons patients terminate therapy. The scale will be used to assess treatment acceptability. Participants who terminate treatment early and their therapists will be asked to independently rate their reasons for termination in 19 domains. Possible total scores on this scale range from 10 to 190-points. Higher scores indicate that the reason for termination had a very great influence on the participant's termination of therapy.
measure: Valued Living Questionnaire
time frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
description: The Valued Living Questionnaire is a self-report measure that assesses participants' values as well as the consistency with which they believe they have been living life according to their values. This scale will be examined as a candidate outcome measure for a future efficacy trial. A possible of 10 to 100 total points for importance of values and 10 to 100 total points for consistency of action with values is demonstrated on the Valued Living Questionnaire (VLQ). Higher scores on the VLQ are indicative of greater importance of values and greater consistency in acting on values.
measure: Outcome Questionnaire-45 (OQ-45)
time frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
description: The Outcome Questionnaire-45 (OQ-45) is a self-report measure that assesses functioning in the psychosocial domains of symptom distress (0-100 points), social relations (0-44 points), and social role functioning (0-36 points). The OQ-45 will be examined as a candidate outcome measure for a future efficacy trial. Higher scores on the OQ-45 are indicative of more symptom distress, difficulty in social relations, and difficulty in social role functioning.
measure: PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a
time frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
description: This is a self-report measure that assesses ability to perform various social activities. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 8 to 40 points on this scale with higher scores associated with greater satisfaction with social roles and activities.
measure: PROMIS v2.0-Social Isolation
time frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
description: This is a self-report measure that assesses experience of social isolation. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 4 to 20 points with higher scores on this scale associated with greater social isolation.
measure: Ecological Momentary Assessment
time frame: Pre-treatment (Up to 30-days before starting treatment for a 1-week period) and post-treatment (0-7 days after treatment completion for a 1-week period)
description: Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance (1 to 5 point rating for experiential avoidance during the assessment period [7 possible items with 2 to 3 administered during each assessment period], higher scores indicate more experiential avoidance), emotions (1 to 5 point rating for each emotion during the assessment period [13 possible items with 2 administered from each category-negative self-directed emotions, negative other-directed emotions, and positive emotions-during each assessment period], higher scores indicate feeling the emotion at an extreme level), and engagement in valued behavior (identify the number of domains from 0 to 10 areas in which they have engaged in the assessment period; qualitative information gathered via audio recording).
arm group label: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
arm group type: Experimental
description: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
arm group label: Present Centered Therapy
arm group type: Active Comparator
description: Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right. PCT could provide another treatment option that might be preferable to some Veterans and promote patient choice. Additionally, PCT would require less clinician training and specialization than ACT-MI. Using PCT as an active comparison condition will determine whether it is necessary to train clinicians in ACT-MI or if therapists with exposure to supportive problem-solving therapy approaches can lead a group that impacts functioning among Veterans reporting moral injury-related distress.
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
description: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
arm group label: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
other name: ACT-MI
intervention type: Behavioral
intervention name: Present Centered Therapy (PCT)
description: Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right.
arm group label: Present Centered Therapy
other name: PCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Lauren Borges, PhD
role: Principal Investigator
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
last name: Lauren Borges, PhD
phone: (314) 566-4118
email: lauren.borges2@va.gov
last name: Sean M Barnes, PhD
phone: (303) 399-8020
phone ext: 4237
email: Sean.Barnes2@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No