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Trial record 4 of 122 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Massachusetts, United States ) | NIH, U.S. Fed

Improving Psychosocial Functioning in Older Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT02803125
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Psychosocial intervention Behavioral: Support group control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Psychosocial Functioning in Older Veterans With PTSD
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
Active Comparator: Developed psychosocial intervention
The active intervention in this study that will be compared to support group control
Behavioral: 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

Placebo Comparator: Support group control
This is the comparison group
Behavioral: 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




Primary Outcome Measures :
  1. Change in the Quality of Life Inventory (QOLI) [ Time Frame: Change from baseline to follow-up at 6 months ]
    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. 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.

  2. Change in the Inventory of Psychosocial Functioning [ Time Frame: Change from baseline to follow-up at 6 months ]
    The IPF is an 80-item self-report measure designed to assess multiple domains of 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 and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning. 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).

  3. Change in the Veterans Rand 12-item Health Survey [ Time Frame: Change from baseline to follow-up at 6 months ]
    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 (M = 50, SD = 10) and the population standard for this measure was recently updated



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants included in the current study will be male Veterans.
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803125


Contacts
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Contact: Anica Pless Kaiser, PhD (857) 364-5309 anica.plesskaiser@va.gov
Contact: Avron Spiro, PhD MS (857) 364-2888 avron.spiro@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maria Higgins    857-364-4802    maria.higgins@va.gov   
Principal Investigator: Anica Pless Kaiser, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Anica Pless Kaiser, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02803125     History of Changes
Other Study ID Numbers: D1832-W
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
Aging
Veteran
Intervention

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders