Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05354492
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2022-04-25
Brief Title:
Evaluating a New Program for Successfully Coping With Adversity
Sponsor:
Wake Forest University
Organization:
Wake Forest University
Study Overview
Official Title:
Evaluation of a New Program to Support Well-Being After Adversity
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lifes challenges This study should not be considered an alternative to any treatment or medication for any disorder or problem
Detailed Description:
Adversity is an inevitable part of human life and can potentially lead to great suffering However facing lifes challenges also presents the opportunity for lasting and meaningful change This phenomenon is referred to as posttraumatic growth PTG and has been defined as positive psychological change experienced as the result of the struggle with highly challenging life circumstances Tedeschi Calhoun 2004 There are several existing psychosocial interventions eg expressive writing that have been shown to promote PTG despite not being intentionally designed to do so Additionally there have been several interventions developed more recently that specifically target the cultivation of PTG although many of them have not been extensively tested Dolbier Jaggars Steinhardt 2010 Shakespeare-Finch et al 2014 SecondStory 20 is an online group-format intervention that was augmented from the original program SecondStory which was designed to promote PTG and well-being in the face of adversity SecondStory 20 incorporates narratives of moral exemplars who have overcome adversity drawing from recent philosophical explorations that have highlighted the pedagogical functions of such exemplars eg Zagzebski 2017 This research has focused on their potential to model virtues that consistently characterize individuals who have overcome adversity eg strength vulnerability wisdom love trust Brady 2018 By including experiences of adversity in these exemplarist narratives we can theoretically increase an individuals admiration for the exemplar and in turn enable effective emulation while also broadening hisher understanding of the moral foundations of the human condition Kidd 2018
This study will take place remotely via phone and zoom The initial interviewscreening will take place via an online Qualtrics survey follow-up by phone with the study coordinator and the intervention sessions will be held online via Zoom with our trained intervention facilitators licensed therapists We will also be providing intervention support via a text messaging platform called Mobile Coach The messages will be the same for all of the participants and they will all receive them at the same time point in the program All of the questionnaires will be completed online via a link that will be texted andor emailed to the participant Once participants see an advertisement and reach out to our study coordinator about their interest in the study they will be directed to complete an online prescreening survey via Qualtrics to assess their eligibility for study participation The study coordinator will then review the online survey and complete the cognitive screener and mental health questions by phone If participants are eligible after the phone screen with the study coordinator they will be scheduled to do a safety assessment via phone with one of our study clinicians Once participants are deemed eligible they will complete the consent form and be randomized into one of two conditions active program or control If a participant is randomized into the control condition they will be placed on a wait list to receive the intervention at a later date If a participant is randomized into the active program condition they will be given the schedule for the group sessions and sent a Zoom link for participation The group intervention sessions will be guided by our trained facilitators for 75-90 minutes weekly for six weeks After week 6 participants who were in the active program group will be asked complete a feedback form as well as to take part in a semi-structured group interview to determine the acceptability and feasibility of the program They will then enter the follow-up period of the study Regardless of condition participants will complete a set of questionnaires at Weeks 0 3 6 9 and 12
After week 12 participants who were randomized to the control condition will receive access to a recorded version of the intervention online The recorded version will include the intervention developer talking through the intervention content and materials on video No study participants will be included in this video
This data will help to inform us whether the new improvements made to the SecondStory protocol are effective in improving participants overall well-being and response to trauma and will guide any future changes made to the intervention protocol
This study will take place remotely via phone and zoom The initial interviewscreening will take place via an online Qualtrics survey follow-up by phone with the study coordinator and the intervention sessions will be held online via Zoom with our trained intervention facilitators licensed therapists We will also be providing intervention support via a text messaging platform called Mobile Coach The messages will be the same for all of the participants and they will all receive them at the same time point in the program All of the questionnaires will be completed online via a link that will be texted andor emailed to the participant Once participants see an advertisement and reach out to our study coordinator about their interest in the study they will be directed to complete an online prescreening survey via Qualtrics to assess their eligibility for study participation The study coordinator will then review the online survey and complete the cognitive screener and mental health questions by phone If participants are eligible after the phone screen with the study coordinator they will be scheduled to do a safety assessment via phone with one of our study clinicians Once participants are deemed eligible they will complete the consent form and be randomized into one of two conditions active program or control If a participant is randomized into the control condition they will be placed on a wait list to receive the intervention at a later date If a participant is randomized into the active program condition they will be given the schedule for the group sessions and sent a Zoom link for participation The group intervention sessions will be guided by our trained facilitators for 75-90 minutes weekly for six weeks After week 6 participants who were in the active program group will be asked complete a feedback form as well as to take part in a semi-structured group interview to determine the acceptability and feasibility of the program They will then enter the follow-up period of the study Regardless of condition participants will complete a set of questionnaires at Weeks 0 3 6 9 and 12
After week 12 participants who were randomized to the control condition will receive access to a recorded version of the intervention online The recorded version will include the intervention developer talking through the intervention content and materials on video No study participants will be included in this video
This data will help to inform us whether the new improvements made to the SecondStory protocol are effective in improving participants overall well-being and response to trauma and will guide any future changes made to the intervention protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None