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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252510981 | Other Grant/Funding Number | Department of Defense Awarding Office: USAMRAA |
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| Name | Class |
|---|---|
| Denver Research Institute | OTHER |
| Northern California Institute of Research and Education | OTHER |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
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Purpose of this study: The purpose of this study is to evaluate the effectiveness of two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. The main questions it aims to answer are:
Participants will be asked to:
This study plans to learn more about two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. These therapies are designed to help Veterans recover after their morals are violated in the warzone.
The main questions it aims to answer are:
Up to 436 people across the country will participate in the study.
Participants who join the study, will be asked to complete a two to two and a half hour initial assessment session online using videoconferencing and VA REDCap, in which the participants would answer questionnaires and interviews about mental health and mental health related behaviors.
At the end of the initial assessment session participants will be randomly assigned to participate in one of the two treatments: (1) ACT for Moral Injury or (2) Present Centered Therapy for Moral Injury. Randomization is a method that is similar to tossing a coin. Treatment groups will be held online using videoconferencing. Treatment groups will be small, consisting of about 8 Veterans in each cohort who also experience moral injury.
The participants in both Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury will meet in a therapy group through videoconferencing over 15- weeks. Both treatments will include 12 90-minute group therapy sessions and 3 30-minute individual therapy sessions. Treatment will take place once a week.
At the end of the 15-weeks participants will be asked to participate in a post-treatment assessment session within one week of treatment completion. During which, participants will be asked questions about their experience of participating in treatment and complete some additional questionnaires. Participants will also complete a qualitative interview about their experience of treatment, and their responses will be audio/video-recorded.
All participants will be asked to complete two additional follow-up assessment sessions (one month and three months after treatment) that can occur via phone or VA REDCap survey link. These surveys take approximately one hour.
This research study is expected to take approximately 4 years. Individual participation in the project will take around 7.5 months (around 4 and a half months of treatment and 3 additional months for follow-up assessment sessions).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-MI | Experimental | Acceptant and Commitment Therapy for Moral Injury |
|
| PCT-MI | Active Comparator | Present Centered Therapy for Moral Injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy for Moral Injury (ACT-MI) | Behavioral | ACT-MI is a 15-week hybrid group (12, 90-minute group sessions) and individual (3, 30-minute case conceptualization sessions) psychotherapy offered over telehealth. The primary goal of the clinician delivering ACT-MI is to help individuals impacted by moral injury live meaningful lives even in the presence of moral pain. This means learning to experience moral pain and connecting with values simultaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to post-treatment on Outcome Questionnaire - 45.2 | The Outcome Questionnaire-45.2 (OQ-45) is widely considered the gold standard of patient-reported outcome measures. Functioning is assessed within the last week across three psychosocial domains of symptom distress (e.g., "I feel nervous"), interpersonal relationships (e.g., "I have frequent arguments"), and social role functioning (e.g., "I find my work/school satisfying") on a scale of 0(Never) to 4(Always) generating a total score between 0 and 180. Higher scores denote greater psychological distress. | Baseline, within 1 week post-treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on Outcome Questionnaire - 45.2 to (a) one- and (b) three-months post-treatment | The Outcome Questionnaire-45.2 (OQ-45) is widely considered the gold standard of patient-reported outcome measures. Functioning is assessed within the last week across three psychosocial domains of symptom distress (e.g., "I feel nervous"), interpersonal relationships (e.g., "I have frequent arguments"), and social role functioning (e.g., "I find my work/school satisfying") on a scale of 0(Never) to 4(Always) generating a total score between 0 and 180. Higher scores denote greater psychological distress. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain VA Regional Medical Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12508337 | Background | Todd DM, Deane FP, Bragdon RA. Client and therapist reasons for termination: a conceptualization and preliminary validation. J Clin Psychol. 2003 Jan;59(1):133-47. doi: 10.1002/jclp.10123. | |
| Background | 80. Hasson-Ohayon I, Roe D, Kravetz, S. A qualitative approach to the evaluation of psychosocial interventions for persons with severe mental illness. Psychological Services. 2006;3(4):262-273. | ||
| 34767617 |
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A final Limited Data Set will be made available, in accordance with VA policy and regulations and per compliance with current IRB and VA R&D approvals in place for this project. A study-specific DUA will be required. Data requests must be made in writing. Requests for access to data obtained from this project will be considered and responded to. Data will be provided electronically, only with a DUA in place, and per VA regulations for transferring data.
After conclusion of the study and dissemination of primary and exploratory results and/or in accordance with VA policy and regulations
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Palo Alto Veterans Institute for Research |
| OTHER |
Participants will be randomly assigned to Acceptance and Commitment Therapy for Moral Injury (ACT-MI) or Present Centered Therapy for Moral Injury (PCT-MI)
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Everyone except for the biostatistician will be blind to condition until randomization at the end of the pre-treatment assessment session. Outcome assessors will remain blind to condition for the duration of the study.
|
| Present Centered Therapy for Moral Injury (PCT-MI) | Behavioral | PCT-MI is a 15-week hybrid group (12, 90-min sessions) and individual (3, 30-min sessions) psychotherapy offered over telehealth. PCT was developed as an active control in a PTSD Prolonged Exposure trial, including psychoeducation and problem-solving as the primary interventions. PCT has been used in multiple clinical trials as an active control condition for PTSD. Additionally, PCT has been used as a control condition in moral injury efficacy trials for interventions like Adaptive Disclosure and Building Spiritual Strength. However, these comparison conditions focused on the treatment of PTSD rather than moral injury. The proposed PCT-MI comparison condition has been adapted to focus specifically on moral injury. PCT-MI includes psychoeducation about moral injury and related problems and individual case conceptualization sessions that are theoretically coherent with the process-based framework and nonspecific therapeutic factors central to PCT and present in most psychotherapies. |
|
| Baseline, 1-month follow up, 3-months follow up |
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