Evaluating a New Program for Successfully Coping With Adversity

NCT05354492 | Unknown

• 1 other identifier: IRB00024316
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

You are invited to participate in a research study involving a new program designed to support people with navigating the changes that can happen after difficult life events. The program activities are aimed at helping you move forward and raise your well-being after experiencing one of life's challenges. This study should not be considered an alternative to any treatment or medication for any disorder or problem.

Conditions

Trauma; Distress, Emotional; Psychological Distress

Outcome Measures

Primary Outcomes (9)

• Post-Traumatic Growth

  We will use the Current-Standing Post-Traumatic Growth Inventory (C-PTGI)

  12 weeks

• Depression

  We will use the Patient Health Questionnaire-8 (PHC-8)

  12 weeks

• Anxiety

  We will use the Generalized Anxiety Disorder 7-item Scale (GAD-7)

  12 weeks

• Wellbeing

  We will use Mental Health Checklist-Short Form (MHC-SF)

  12 weeks

• Vulnerability

  We will use the Multidimensional Scale of Perceived Social Support (MSPSS)

  12 weeks

• Wisdom

  We will use the Claremont Purpose Scale

  12 weeks

• Strength

  We will use the State Hope Scale

  12 weeks

• Morality

  We will use the Compassion Scale

  12 weeks

• Narrative Identity

  We will code short qualitative responses for Personal Growth, Meaning-Making, Resolution, and Emotional Processing (Positive Reframing)

  12 weeks

Study Arms (2)

Active Program Participant

EXPERIMENTAL

You will actively take part in the group program via Zoom with our program facilitators.

Other: Program to Support Well-Being after Adversity

Program Wait List

NO INTERVENTION

You will be placed on a wait list to take part in the program.

Interventions

Program to Support Well-Being after Adversity OTHER

You will be asked to meet on Zoom weekly for 6 weeks with our trained program facilitators along with the other 6-10 members of the intervention group. Meetings will last approximately 75-90 minutes each, and will involve a variety of discussions and activities related to navigating the changes you may face after experiencing a difficult life event. These sessions will be audio-recorded for research purposes and to ensure that facilitators are doing a good job delivering the program.

Active Program Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old
• Have experienced trauma within the last 3 months to 5 years
• Feeling some level of subjective distress as a result of the trauma
• Read and understand English
• Have consistent access to the internet

You may not qualify if:

• Suicide risk
• Cognitive Impairment
• Diagnosed with a Psychotic Disorder
• Diagnosed with moderate to severe PTSD

Sponsors & Collaborators

• Wake Forest University: lead
• John Templeton Foundation: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Eranda Jayawickreme, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Keller, MA

CONTACT

336-758-5786; kellerc@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: February 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

US (1)