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The purpose of this project is to develop an intervention to improve psychosocial functioning and quality of life for older Veterans with partial or full PTSD.
This project will develop, implement, and evaluate a group protocol geared toward restoring older Veterans to better, fuller functioning. This project will determine the feasibility and acceptability of such an intervention. The intervention developed will then be compared to a support group control condition. Primary outcomes are psychosocial functioning and quality of life, with PTSD and depressive symptoms as secondary outcomes. A complementary objective is to improve attitudes toward mental health treatment and to increase readiness for change and engagement in evidence-based psychotherapies, as appropriate. Results from this study will provide feasibility data for future development and testing of the intervention protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developed psychosocial intervention | Active Comparator | The active intervention in this study that will be compared to support group control |
|
| Support group control | Placebo Comparator | This is the comparison group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial intervention | Behavioral | This intervention is to be developed during the study. It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support. In addition, psychoeducation about behavioral activation and stress management will likely be included |
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | The IPF is an 80-item self-report measure designed to assess functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Respondents have the option to skip sections that do not apply to them. The IPF has excellent internal consistency reliability (overall alpha = .93) and the scale correlates with other self-report measures of quality of life and functional impairment, such as the QOLI (r = .59). Reporting on romantic relationships (range = 0-66), family (range = 0-42), and friends/socializing (range = 0-48) functioning subscales here. Higher scores indicate more impairment. | Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
| Quality of Life Inventory (QOLI) | The QOLI is a 32 item self-report measure that assesses life satisfaction across 16 life domains (e.g., health, work, recreation). For each domain, the respondent rates how important the domain is on a 0-2 scale and how satisfied he or she is in this area of life on a 7-point scale. Satisfaction scores on the measure are weighted based on the respondent's rating of the importance of the life domain in order to achieve a total score with higher scores indicating higher quality of life. The measure was validated across a number of samples, including psychiatric inpatient and outpatient VA samples. Test-retest reliability was excellent over a one-month interval (r = .91) as was the internal consistency of the measure (alphas ranged from .86-.89). The measure also demonstrated convergent and discriminant validity with other measures of life satisfaction. T scores were used with range 0 - 100, Mean (of reference population) =50, Standard deviation = 10 | Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
| Veterans Rand 12-item (VR-12) Health Survey |
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Inclusion Criteria:
Focus groups:
Pilot:
Comparison:
Exclusion Criteria:
Focus groups:
Pilot:
Comparison:
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| Name | Affiliation | Role |
|---|---|---|
| Anica Pless Kaiser, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40569724 | Derived | Pless Kaiser A, Ream M, Spiro A, Sloan DM, Cook JM, Vogt D, Moye JA. Feasibility, acceptability, and outcomes: A pilot trial of the enhancing social function in older veterans with PTSD (ESVP) group intervention. Psychol Serv. 2026 May;23(2):293-306. doi: 10.1037/ser0000962. Epub 2025 Jun 26. | |
| 38432471 | Derived |
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Any data to be shared will be coded data within a limited dataset, with appropriate Data Use Agreement (DUA) in place.
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| ID | Title | Description |
|---|---|---|
| FG000 | Developed Psychosocial Intervention | The active intervention in this study that will be compared to support group control Psychosocial intervention: This intervention is to be developed during the study. It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support. In addition, psychoeducation about behavioral activation and stress management will likely be included |
| FG001 | Support Group Control | This is the comparison group Support group control: The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention. In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Developed Psychosocial Intervention | The active intervention in this study that will be compared to support group control Psychosocial intervention: This intervention is to be developed during the study. It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support. In addition, psychoeducation about behavioral activation and stress management will likely be included |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | The IPF is an 80-item self-report measure designed to assess functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Respondents have the option to skip sections that do not apply to them. The IPF has excellent internal consistency reliability (overall alpha = .93) and the scale correlates with other self-report measures of quality of life and functional impairment, such as the QOLI (r = .59). Reporting on romantic relationships (range = 0-66), family (range = 0-42), and friends/socializing (range = 0-48) functioning subscales here. Higher scores indicate more impairment. | Veterans who completed baseline and post-group assessments (assessed at the final group session). The number analyzed is different from the number who completed the study because not all participants completed enough items of each measure to be included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
Data to inform adverse event reporting were collected during the entire data collection process that included participants. Monitoring/assessment for adverse events for each participant was completed through study completion, an average of about 8-9 months per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Developed Psychosocial Intervention | The active intervention in this study that will be compared to support group control Psychosocial intervention: This intervention is to be developed during the study. It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support. In addition, psychoeducation about behavioral activation and stress management will likely be included |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anica Pless Kaiser, PhD | VA Boston Healthcare System | 857-364-5309 | Anica.PlessKaiser@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2021 | Sep 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2020 | Sep 13, 2023 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Support group control | Behavioral | The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention. In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members |
|
The VR-12 is a 12-item scale that assesses the effects of physical and mental health on well-being, and is often used to assess quality of life. Item scores are used to compute two broad component scores: the physical component score (PCS) and the mental component score (MCS). The component scores are standardized T-Scores and the population standard for this measure was recently updated. Higher scores indicate better functioning. T scores were used with range 0 - 100, Mean (of reference population) = 50, Standard deviation = 10 |
| Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
| Pless Kaiser A, Daks JS, Korsun L, Heintz H, Moye J, Sloan DM, Cook JM, Vogt D, Spiro A 3rd. Enhancing social functioning in older veterans with PTSD: Rationale and design of an intervention and initial RCT. Contemp Clin Trials. 2024 Apr;139:107485. doi: 10.1016/j.cct.2024.107485. Epub 2024 Mar 2. |
| BG001 | Support Group Control | This is the comparison group Support group control: The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention. In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Inventory of Psychosocial Functioning - Romantic | Lower scores indicate less impairment; Range = 0 - 66. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life Inventory | Higher scores indicate greater quality of life; T scores values (e.g., range 0 - 100, 50 indicates the population mean with a standard deviation of 10). | Mean | Standard Deviation | T-score |
|
| VR-12 | T-scores (e.g., range 0 - 100, 50 indicates the population mean with a standard deviation of 10); Higher scores indicate better functioning | Mean | Standard Deviation | T-score |
|
|
|
|
| Primary | Quality of Life Inventory (QOLI) | The QOLI is a 32 item self-report measure that assesses life satisfaction across 16 life domains (e.g., health, work, recreation). For each domain, the respondent rates how important the domain is on a 0-2 scale and how satisfied he or she is in this area of life on a 7-point scale. Satisfaction scores on the measure are weighted based on the respondent's rating of the importance of the life domain in order to achieve a total score with higher scores indicating higher quality of life. The measure was validated across a number of samples, including psychiatric inpatient and outpatient VA samples. Test-retest reliability was excellent over a one-month interval (r = .91) as was the internal consistency of the measure (alphas ranged from .86-.89). The measure also demonstrated convergent and discriminant validity with other measures of life satisfaction. T scores were used with range 0 - 100, Mean (of reference population) =50, Standard deviation = 10 | Baseline and post-group assessments (assessed at the last session of the intervention). The number analyzed is different from the number who completed the study because not all participants completed enough items of each measure to be included in the analysis. | Posted | Mean | Standard Deviation | T-scores | Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
|
|
|
| Primary | Veterans Rand 12-item (VR-12) Health Survey | The VR-12 is a 12-item scale that assesses the effects of physical and mental health on well-being, and is often used to assess quality of life. Item scores are used to compute two broad component scores: the physical component score (PCS) and the mental component score (MCS). The component scores are standardized T-Scores and the population standard for this measure was recently updated. Higher scores indicate better functioning. T scores were used with range 0 - 100, Mean (of reference population) = 50, Standard deviation = 10 | Baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline). The number analyzed is different from the number who completed the study because not all participants completed enough items of each measure to be included in the analysis. | Posted | Mean | Standard Deviation | T-scores | Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Support Group Control | This is the comparison group Support group control: The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention. In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members | 0 | 16 | 0 | 16 | 0 | 16 |
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