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Improving Psychosocial Functioning in Older Veterans With PTSD

Improving Psychosocial Functioning in Older Veterans With PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02803125
Enrollment
34
Registered
2016-06-16
Start date
2017-11-14
Completion date
2022-09-23
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

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

BEHAVIORALPsychosocial 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

BEHAVIORALSupport 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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesReporting 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 SurveyReporting 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

ArmCount
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
Total34

Baseline characteristics

CharacteristicDeveloped Psychosocial InterventionSupport Group ControlTotal
Age, Continuous70.56 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 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants14 Participants32 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Inventory of Psychosocial Functioning - Romantic27.5 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 Inventory32.83 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 Participants1 Participants4 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Unanswered
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
14 Participants15 Participants29 Participants
Region of Enrollment
United States
18 Participants16 Participants34 Participants
Sex: Female, Male
Female
2 Participants0 Participants2 Participants
Sex: Female, Male
Male
16 Participants16 Participants32 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 16
other
Total, other adverse events
0 / 180 / 16
serious
Total, serious adverse events
0 / 180 / 16

Outcome results

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.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Developed Psychosocial InterventionInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - romantic24.1 units on a scaleStandard Deviation 10
Developed Psychosocial InterventionInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - Family12.2 units on a scaleStandard Deviation 9.9
Developed Psychosocial InterventionInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - Friends/Social12.5 units on a scaleStandard Deviation 6.4
Support Group ControlInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - romantic15.7 units on a scaleStandard Deviation 4
Support Group ControlInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - Family17.5 units on a scaleStandard Deviation 7.7
Support Group ControlInventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing SubscalesIPF - Friends/Social15.4 units on a scaleStandard Deviation 5.2
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

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.

ArmMeasureValue (MEAN)Dispersion
Developed Psychosocial InterventionQuality of Life Inventory (QOLI)34.69 T-scoresStandard Deviation 2.63
Support Group ControlQuality of Life Inventory (QOLI)33.6 T-scoresStandard Deviation 1.9
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

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.

ArmMeasureGroupValue (MEAN)Dispersion
Developed Psychosocial InterventionVeterans Rand 12-item (VR-12) Health SurveyMental Health Summary44.59 T-scoresStandard Deviation 9.55
Developed Psychosocial InterventionVeterans Rand 12-item (VR-12) Health SurveyPhysical Health Summary42.08 T-scoresStandard Deviation 8.15
Support Group ControlVeterans Rand 12-item (VR-12) Health SurveyMental Health Summary40.37 T-scoresStandard Deviation 9.14
Support Group ControlVeterans Rand 12-item (VR-12) Health SurveyPhysical Health Summary37.44 T-scoresStandard Deviation 9.34

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026