Trial Outcomes & Findings for Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans (NCT NCT03760731)

NCT ID: NCT03760731

Last Updated: 2025-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Post-treatment (0-7 days after treatment completion)

Results posted on

2025-12-29

Participant Flow

Participant milestones

Participant milestones
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Pre-Treatment and Randomization
STARTED
38
36
Pre-Treatment and Randomization
COMPLETED
37
36
Pre-Treatment and Randomization
NOT COMPLETED
1
0
Treatment
STARTED
37
36
Treatment
COMPLETED
27
21
Treatment
NOT COMPLETED
10
15
Post-Treatment Assessment
STARTED
29
27
Post-Treatment Assessment
COMPLETED
29
27
Post-Treatment Assessment
NOT COMPLETED
0
0
One-Month Follow-Up Assessments
STARTED
25
24
One-Month Follow-Up Assessments
COMPLETED
25
24
One-Month Follow-Up Assessments
NOT COMPLETED
0
0
Three-Month Follow-up Assessments
STARTED
25
24
Three-Month Follow-up Assessments
COMPLETED
25
24
Three-Month Follow-up Assessments
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Pre-Treatment and Randomization
Withdrawal by Subject
1
0
Treatment
Attended less than 70% of sessions
10
15

Baseline Characteristics

Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=38 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Total
n=74 Participants
Total of all reporting groups
Age, Continuous
42 years
n=9 Participants
40.5 years
n=6 Participants
41.5 years
n=9 Participants
Sex: Female, Male
Female
3 Participants
n=9 Participants
4 Participants
n=6 Participants
7 Participants
n=9 Participants
Sex: Female, Male
Male
35 Participants
n=9 Participants
32 Participants
n=6 Participants
67 Participants
n=9 Participants
Race/Ethnicity, Customized
White
28 participants
n=9 Participants
28 participants
n=6 Participants
56 participants
n=9 Participants
Race/Ethnicity, Customized
Black
1 participants
n=9 Participants
2 participants
n=6 Participants
3 participants
n=9 Participants
Race/Ethnicity, Customized
Native American/Alaskan Native
1 participants
n=9 Participants
1 participants
n=6 Participants
2 participants
n=9 Participants
Race/Ethnicity, Customized
Asian
1 participants
n=9 Participants
1 participants
n=6 Participants
2 participants
n=9 Participants
Race/Ethnicity, Customized
Pacific Islander
2 participants
n=9 Participants
2 participants
n=6 Participants
4 participants
n=9 Participants
Race/Ethnicity, Customized
Multiracial
3 participants
n=9 Participants
1 participants
n=6 Participants
4 participants
n=9 Participants
Race/Ethnicity, Customized
Other
2 participants
n=9 Participants
1 participants
n=6 Participants
3 participants
n=9 Participants
Region of Enrollment
United States
38 Participants
n=9 Participants
36 Participants
n=6 Participants
74 Participants
n=9 Participants
Sexual Orientation
Heterosexual
35 participants
n=9 Participants
32 participants
n=6 Participants
67 participants
n=9 Participants
Sexual Orientation
Gay/Lesbian/Queer/Bisexual
3 participants
n=9 Participants
3 participants
n=6 Participants
6 participants
n=9 Participants
Sexual Orientation
Other
0 participants
n=9 Participants
1 participants
n=6 Participants
1 participants
n=9 Participants

PRIMARY outcome

Timeframe: Post-treatment (0-7 days after treatment completion)

Population: Post-treatment data were collected from all participants who completed at least one treatment session. 9 participants were lost to follow-up from ACT-MI and 9 participants were lost to follow-up from PCT-MI.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=29 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=27 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Client Satisfaction Questionnaire
27 Participants
22 Participants

PRIMARY outcome

Timeframe: Post-treatment (0-7 days after treatment completion)

Population: Post-treatment data were collected from all participants who completed at least one treatment session. All participants responded related to each NEII domain. 9 participants were lost to follow-up from ACT-MI and 9 participants were lost to follow-up from PCT-MI.

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. The NEII includes domains related to description of intervention process, description of intervention outcome, evaluation of intervention process, and evaluation of intervention outcome. Data provided reflects the number of participants who provided perspective feedback.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=29 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=27 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Narrative Evaluation of Intervention Interview
29 Participants
27 Participants

PRIMARY outcome

Timeframe: Post-treatment (0-7 days after terminating treatment)

Population: Data reflects those who terminated treatment.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=38 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=26 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Reasons for Termination (Client and Therapist Versions)
10 Participants
14 Participants

SECONDARY outcome

Timeframe: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

Population: The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=37 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Valued Living Questionnaire
Pre-Treatment
40.9 score on a scale
Interval 35.06 to 46.74
41.55 score on a scale
Interval 36.12 to 46.98
Valued Living Questionnaire
Post-Treatment
49.83 score on a scale
Interval 42.95 to 56.73
42.63 score on a scale
Interval 35.88 to 49.99
Valued Living Questionnaire
One-Month Follow-Up
50.16 score on a scale
Interval 42.01 to 58.31
42.01 score on a scale
Interval 34.69 to 49.33
Valued Living Questionnaire
Three-Month Follow-Up
45.77 score on a scale
Interval 38.15 to 53.39
41.82 score on a scale
Interval 35.55 to 48.09

SECONDARY outcome

Timeframe: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

Population: The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=37 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Outcome Questionnaire-45 (OQ-45)
Pre-Treatment
69.89 score on a scale
Interval 64.0 to 75.78
69.78 score on a scale
Interval 63.11 to 76.45
Outcome Questionnaire-45 (OQ-45)
Post-Treatment
53.62 score on a scale
Interval 45.22 to 62.02
63.30 score on a scale
Interval 59.79 to 78.81
Outcome Questionnaire-45 (OQ-45)
One-Month Follow-Up
60.76 score on a scale
Interval 51.34 to 70.18
66.92 score on a scale
Interval 57.69 to 76.15
Outcome Questionnaire-45 (OQ-45)
Three-Month Follow-Up
63.76 score on a scale
Interval 54.07 to 73.45
63.21 score on a scale
Interval 53.37 to 73.05

SECONDARY outcome

Timeframe: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

Population: The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=36 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
PROMIS Short Form v2.0-Satisfaction With Social Roles and Activities 8a
Pre-Treatment
21.53 score on a scale
Interval 18.84 to 24.22
21.33 score on a scale
Interval 18.84 to 23.82
PROMIS Short Form v2.0-Satisfaction With Social Roles and Activities 8a
Post-Treatment
27.14 score on a scale
Interval 24.23 to 30.05
25.33 score on a scale
Interval 21.79 to 28.87
PROMIS Short Form v2.0-Satisfaction With Social Roles and Activities 8a
One-Month Follow-Up
24.92 score on a scale
Interval 21.89 to 27.95
23.28 score on a scale
Interval 20.39 to 26.17
PROMIS Short Form v2.0-Satisfaction With Social Roles and Activities 8a
Three-Month Follow-Up
23.96 score on a scale
Interval 20.16 to 27.76
23.91 score on a scale
Interval 20.9 to 26.92

SECONDARY outcome

Timeframe: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

Population: The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.

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.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=37 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
PROMIS v2.0-Social Isolation
Pre-Treatment
14.14 score on a scale
Interval 12.9 to 15.38
14.39 score on a scale
Interval 13.36 to 15.42
PROMIS v2.0-Social Isolation
Post-Treatment
12.24 score on a scale
Interval 10.8 to 13.68
13.22 score on a scale
Interval 11.79 to 14.65
PROMIS v2.0-Social Isolation
One-Month Follow-Up
13.40 score on a scale
Interval 11.83 to 14.97
14.08 score on a scale
Interval 12.72 to 15.42
PROMIS v2.0-Social Isolation
Three-Month Follow-Up
13.48 score on a scale
Interval 11.92 to 15.04
13.78 score on a scale
Interval 11.94 to 15.62

SECONDARY outcome

Timeframe: 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)

Population: EMA procedures tested proved not to be feasible and resulted in a problematic amount of missing data. Most Veterans chose not to participate largely due to the need to present to the VA in person to return the data due to VA regulatory barriers.

Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance, emotions, and engagement in valued behavior. However, because VA regulations and use of a new application, analyses will focus on feasibility of completing the EMA and will be reported as number of participants who provided EMA data. Actual EMA responses will only be analyzed if there is sufficient participation. Actual EMA responses will only be analyzed if there are 25% or more reporting participants.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=38 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Ecological Momentary Assessment
9 Participants
5 Participants

SECONDARY outcome

Timeframe: Pre-treatment, post-treatment, one-month follow-up, and three-month follow-up

Population: The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.

Self-report measure that assesses impairment within the last 30 days across a spectrum of psychosocial domains. Will be examined as a candidate outcome measure for a future efficacy trial. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.

Outcome measures

Outcome measures
Measure
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
n=37 Participants
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 fifteen session intervention is a hybrid group and individual treatment spanning twelve, 90-minute sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. 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. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives.
Present Centered Therapy for Moral Injury (PCT-MI)
n=36 Participants
Present Centered Therapy for Moral Injury (PCT-MI) was adapted from the version of PCT used in PTSD clinical trials (Frost et al., 2014; Wattenberg et al., 2021) to include moral injury psychoeducation and individual case conceptualization sessions consistent with a process-based theoretical framework. PCT-MI is a fifteen session intervention consisting of a hybrid of twelve 90-minute group psychotherapy sessions and three 30-minute individual case conceptualization sessions at the beginning, middle, and end of treatment. PCT-MI group sessions are process-based and emphasize problem-solving moral injury-related life issues.
Inventory of Psychosocial Functioning
Pre-Treatment
2.78 score on a scale
Interval 2.56 to 3.0
2.77 score on a scale
Interval 2.58 to 2.96
Inventory of Psychosocial Functioning
Post-Treatment
2.41 score on a scale
Interval 2.17 to 2.65
2.57 score on a scale
Interval 2.33 to 2.81
Inventory of Psychosocial Functioning
One-Month Follow-Up
2.43 score on a scale
Interval 2.14 to 2.72
2.74 score on a scale
Interval 2.4 to 3.08
Inventory of Psychosocial Functioning
Three-Month Follow-Up
2.51 score on a scale
Interval 2.21 to 2.81
2.64 score on a scale
Interval 2.39 to 2.89

Adverse Events

Acceptance and Commitment Therapy for Moral Injury (ACT-MI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Present Centered Therapy for Moral Injury (PCT-MI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lauren Michelle Borges, PhD

Rocky Mountain Regional VA Medical Center

Phone: 303-916-0128

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place