Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, Aging, Veteran, Intervention
Brief summary
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.
Detailed description
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.
Interventions
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
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
Sponsors
Study design
Eligibility
Inclusion criteria
Focus groups: * Veterans need to be at least 60 years old to be eligible to participate in the focus groups. * Potential participants will be assessed with the Primary Care Posttraumatic Stress Disorder Screener (PC-PTSD-5) prior to being invited to participate. * Inclusion criteria include endorsement of a military-related criterion A event and a score of 3 or higher on the PC-PTSD-5. Pilot: * Veterans need to be at least 60 years old to be eligible to participate in the study. * Potential participants will be assessed for PTSD symptoms. * Inclusion criteria include endorsement of a military-related criterion A event and several PTSD symptoms. Comparison: * Veterans need to be at least 60 years old to be eligible to participate in the study. * For both intervention and support groups, participants (who will be assessed for PTSD), must endorse a military-related criterion A event and several PTSD symptoms.
Exclusion criteria
Focus groups: * Veterans who are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder. * Potential participants will also be excluded if they do not agree to be audio recorded. Pilot: * Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder. * Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study. * Potential participants will also be excluded if they do not agree to be audio recorded. Comparison: * Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder. * Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study. * Potential participants will also be excluded if they do not agree to be audio recorded. * In addition, Veterans who participated in the pilot phase of the study will be excluded from participating in the comparison condition phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline) | 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. |
| Quality of Life Inventory (QOLI) | Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) | 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 |
| Veterans Rand 12-item (VR-12) Health Survey | Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Developed Psychosocial Intervention | Support Group Control | Total |
|---|---|---|---|
| Age, Continuous | 70.56 years STANDARD_DEVIATION 5.56 | 73.56 years STANDARD_DEVIATION 4.41 | 71.97 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Inventory of Psychosocial Functioning - Romantic | 27.5 units on a scale STANDARD_DEVIATION 11 | 17.0 units on a scale STANDARD_DEVIATION 12.3 | 24.34 units on a scale STANDARD_DEVIATION 11.84 |
| Quality of Life Inventory | 32.83 T-score STANDARD_DEVIATION 2.58 | 34.38 T-score STANDARD_DEVIATION 2.63 | 33.48 T-score STANDARD_DEVIATION 2.69 |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unanswered | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 14 Participants | 15 Participants | 29 Participants |
| Region of Enrollment United States | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
| VR-12 Mental Health Summary | 41.31 T-score STANDARD_DEVIATION 8.85 | 42.36 T-score STANDARD_DEVIATION 7.96 | 41.75 T-score STANDARD_DEVIATION 8.37 |
| VR-12 Physical Health Summary | 39.01 T-score STANDARD_DEVIATION 8.27 | 35.04 T-score STANDARD_DEVIATION 10.78 | 37.34 T-score STANDARD_DEVIATION 9.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
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.
Time frame: Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Developed Psychosocial Intervention | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - romantic | 24.1 units on a scale | Standard Deviation 10 |
| Developed Psychosocial Intervention | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - Family | 12.2 units on a scale | Standard Deviation 9.9 |
| Developed Psychosocial Intervention | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - Friends/Social | 12.5 units on a scale | Standard Deviation 6.4 |
| Support Group Control | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - romantic | 15.7 units on a scale | Standard Deviation 4 |
| Support Group Control | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - Family | 17.5 units on a scale | Standard Deviation 7.7 |
| Support Group Control | Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales | IPF - Friends/Social | 15.4 units on a scale | Standard Deviation 5.2 |
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
Time frame: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Developed Psychosocial Intervention | Quality of Life Inventory (QOLI) | 34.69 T-scores | Standard Deviation 2.63 |
| Support Group Control | Quality of Life Inventory (QOLI) | 33.6 T-scores | Standard Deviation 1.9 |
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
Time frame: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Developed Psychosocial Intervention | Veterans Rand 12-item (VR-12) Health Survey | Mental Health Summary | 44.59 T-scores | Standard Deviation 9.55 |
| Developed Psychosocial Intervention | Veterans Rand 12-item (VR-12) Health Survey | Physical Health Summary | 42.08 T-scores | Standard Deviation 8.15 |
| Support Group Control | Veterans Rand 12-item (VR-12) Health Survey | Mental Health Summary | 40.37 T-scores | Standard Deviation 9.14 |
| Support Group Control | Veterans Rand 12-item (VR-12) Health Survey | Physical Health Summary | 37.44 T-scores | Standard Deviation 9.34 |