Trial Outcomes & Findings for Improving Psychosocial Functioning in Older Veterans With PTSD (NCT NCT02803125)

Last Updated: 2024-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)

Results posted on

2024-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	18	16
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Psychosocial Functioning in Older Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Developed Psychosocial Intervention n=18 Participants 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	Support Group Control n=16 Participants 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	Total n=34 Participants Total of all reporting groups
VR-12 Physical Health Summary	39.01 T-score STANDARD_DEVIATION 8.27 • n=5 Participants	35.04 T-score STANDARD_DEVIATION 10.78 • n=7 Participants	37.34 T-score STANDARD_DEVIATION 9.45 • n=5 Participants
Age, Continuous	70.56 years STANDARD_DEVIATION 5.56 • n=5 Participants	73.56 years STANDARD_DEVIATION 4.41 • n=7 Participants	71.97 years STANDARD_DEVIATION 5.20 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unanswered	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Inventory of Psychosocial Functioning - Romantic	27.5 units on a scale STANDARD_DEVIATION 11.0 • n=5 Participants	17.0 units on a scale STANDARD_DEVIATION 12.3 • n=7 Participants	24.34 units on a scale STANDARD_DEVIATION 11.84 • n=5 Participants
Quality of Life Inventory	32.83 T-score STANDARD_DEVIATION 2.58 • n=5 Participants	34.38 T-score STANDARD_DEVIATION 2.63 • n=7 Participants	33.48 T-score STANDARD_DEVIATION 2.69 • n=5 Participants
VR-12 Mental Health Summary	41.31 T-score STANDARD_DEVIATION 8.85 • n=5 Participants	42.36 T-score STANDARD_DEVIATION 7.96 • n=7 Participants	41.75 T-score STANDARD_DEVIATION 8.37 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Developed Psychosocial Intervention n=7 Participants 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	Support Group Control n=3 Participants 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
Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales IPF - romantic	24.1 units on a scale Standard Deviation 10.0	15.7 units on a scale Standard Deviation 4.0
Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales IPF - Family	12.2 units on a scale Standard Deviation 9.9	17.5 units on a scale Standard Deviation 7.7
Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales IPF - Friends/Social	12.5 units on a scale Standard Deviation 6.4	15.4 units on a scale Standard Deviation 5.2

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Developed Psychosocial Intervention n=13 Participants 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	Support Group Control n=10 Participants 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
Quality of Life Inventory (QOLI)	34.69 T-scores Standard Deviation 2.63	33.6 T-scores Standard Deviation 1.90

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Developed Psychosocial Intervention n=13 Participants 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	Support Group Control n=10 Participants 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
Veterans Rand 12-item (VR-12) Health Survey Physical Health Summary	42.08 T-scores Standard Deviation 8.15	37.44 T-scores Standard Deviation 9.34
Veterans Rand 12-item (VR-12) Health Survey Mental Health Summary	44.59 T-scores Standard Deviation 9.55	40.37 T-scores Standard Deviation 9.14

Adverse Events

Developed Psychosocial Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Support Group Control

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

Anica Pless Kaiser, PhD

VA Boston Healthcare System

Phone: 857-364-5309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place