NCT03563820

Brief Summary

It is common for Veterans with injuries, illnesses, or physical disabilities to experience depression, post-traumatic stress disorder (PTSD), chronic pain, and other concerns. They may also have goals like becoming happier or better able to cope with challenges that life brings. The purpose of this research study is to learn whether Veterans like and benefit from a 5-week, group-based positive psychology program aimed at improving mental health, resilience, well-being, and quality of life. Participants will be asked to complete several assessments (surveys/interviews) over the course of the study that are not considered part of standard care. Additionally, participants will be asked to participate in a focus group at the end of the study to provide feedback about their experiences in the group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

June 8, 2018

Last Update Submit

January 22, 2020

Conditions

Keywords

Positive PsychologyResilienceWell-Being

Outcome Measures

Primary Outcomes (1)

  • Change in Depression from Pre-Group to 5-Weeks Post-Group

    Change in depression will be measured using the PROMIS Depression Short Form-8A. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of depression.

    Pre-Group (up to 2-weeks prior to Session 1 of group program), Post-Group (immediately after Session 5 of group program, window open up to 4 weeks after), 5-Week Follow-Up (5 weeks after Session 5 of program, window open up to 4 weeks after)

Interventions

The Resilience and Well-Being Program is offered through VA Puget Sound Rehabilitation Care Services as part of standard clinical care offerings. The program includes five (5) positive psychology group sessions once a week for five weeks. Participants will use strengths-based strategies, narrative strategies, and prospective strategies to learn ways to deal with stressful life challenges and improve their mental health and well-being. Each participant will be given a brief rating sheet at the end of each session to fill out. The rating sheet will ask participants to rate different aspects of the session (e.g., how helpful or interesting the session was to the participant), if home practice activities were assigned, whether the participant completed the home practice assignment, as well as feedback to improve that session.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be Veterans enrolled in the VA Puget Sound Resilience and Well-Being Program, which is offered through VA Puget Sound Rehabilitation Care Services as part of standard clinical care.

You may qualify if:

  • Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs)
  • years of age or older
  • Enrolled, or eligible and willing to enroll, in the Resilience and Well-Being group treatment program (offered as part of standard clinical care in VA Puget Sound Rehabilitation Care Services)
  • Able to read, speak, and understand English
  • Has been seen at least once in the past 12 months in a VAPSHCS clinic that provides rehabilitation services to individuals with rehabilitation needs related to conditions including (but not limited to) multiple sclerosis (MS), traumatic brain injury (TBI), amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), stroke, myocardial infarction, limb loss, polytrauma, neuromuscular conditions, musculoskeletal problems, impairing but medically unexplained symptoms, and/or pain, OR has a diagnosis of such a condition
  • Positive screen for depression, PTSD, or chronic pain

You may not qualify if:

  • Primary psychotic or major thought disorder as listed in participant's medical record or self-reported
  • Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months
  • Any behavioral, cognitive, or psychiatric issues that would indicate the participant may be inappropriate in a group setting or for this particular group-format intervention, subject to clinician discretion
  • Difficulties or limitations communicating over the telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Chronic PainDepressionStress Disorders, Post-TraumaticWounds and InjuriesChronic Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersDisease AttributesPathologic Processes

Study Officials

  • Rhonda Williams, Ph.D.

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Psychologist

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

June 15, 2018

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations