TraumaNCT05354492
Evaluating a New Program for Successfully Coping With Adversity
A study testing Program to Support Well-Being after Adversity in people with Trauma and Distress, Emotional, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Distress, Emotional, Psychological Distress
- What is being tested?
- Program to Support Well-Being after Adversity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suicide risk
- Cognitive Impairment
- Diagnosed with a Psychotic Disorder
- Diagnosed with moderate to severe PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Casey Keller, MA
About this study
Official title: Evaluation of a New Program to Support Well-Being After Adversity
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.
Read the detailed description
Adversity is an inevitable part of human life and can potentially lead to great suffering. However, facing life's 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 (e.g., 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 2.0 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 2.0 incorporates narratives of moral exemplars who have overcome adversity, drawing from recent philosophical explorations that have highlighted the pedagogical functions of such exemplars (e.g. Zagzebski, 2017). This research has focused on their potential to model virtues that consistently characterize individuals who have overcome adversity (e.g. strength, vulnerability, wisdom, love, trust) (Brady, 2018). By including experiences of adversity in these exemplarist narratives, we can theoretically increase an individual's admiration for the exemplar, and in turn enable effective emulation while also broadening his/her understanding of the moral foundations of the human condition (Kidd, 2018).
This study will take place remotely via phone and zoom. The initial interview/screening 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 and/or 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.
- Conditions
- Trauma, Distress, Emotional, Psychological Distress
- Being tested
- Program to Support Well-Being after Adversity
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program to Support Well-Being after AdversityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Program Participant | Experimental | You will actively take part in the group program via Zoom with our program facilitators. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Growth
We will use the Current-Standing Post-Traumatic Growth Inventory (C-PTGI)
Measured: 12 weeks
Depression
We will use the Patient Health Questionnaire-8 (PHC-8)
Measured: 12 weeks
Anxiety
We will use the Generalized Anxiety Disorder 7-item Scale (GAD-7)
Measured: 12 weeks
Wellbeing
We will use Mental Health Checklist-Short Form (MHC-SF)
Measured: 12 weeks
Vulnerability
We will use the Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 12 weeks
Wisdom
We will use the Claremont Purpose Scale
Measured: 12 weeks
Strength
We will use the State Hope Scale
Measured: 12 weeks
Morality
We will use the Compassion Scale
Measured: 12 weeks
Narrative Identity
We will code short qualitative responses for Personal Growth, Meaning-Making, Resolution, and Emotional Processing (Positive Reframing)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Feb 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- John Templeton Foundation
- Responsible party
- Sponsor
- Investigators
- Eranda Jayawickreme, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354492
- Sponsor's protocol ID
- IRB00024316
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Program to Support Well-Being After Adversity
- ClinicalTrials.gov ID
- NCT05354492
- Acronym / sponsor ID
- IRB00024316
- Conditions
- Trauma, Distress, Emotional, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- John Templeton Foundation
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adversity is an inevitable part of human life and can potentially lead to great suffering. However, facing life's 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 (e.g., 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 2.0 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 2.0 incorporates narratives of moral exemplars who have overcome adversity, drawing from recent philosophical explorations that have highlighted the pedagogical functions of such exemplars (e.g. Zagzebski, 2017). This research has focused on their potential to model virtues that consistently characterize individuals who have overcome adversity (e.g. strength, vulnerability, wisdom, love, trust) (Brady, 2018). By including experiences of adversity in these exemplarist narratives, we can theoretically increase an individual's admiration for the exemplar, and in turn enable effective emulation while also broadening his/her understanding of the moral foundations of the human condition (Kidd, 2018).
This study will take place remotely via phone and zoom. The initial interview/screening 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 and/or 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Program Participant | Experimental | Other: Program to Support Well-Being after AdversityYou will actively take part in the group program via Zoom with our program facilitators. |
| Program Wait List | No intervention | –You will be placed on a wait list to take part in the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Suicide risk
- Cognitive Impairment
- Diagnosed with a Psychotic Disorder
- Diagnosed with moderate to severe PTSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program to Support Well-Being after AdversityYou 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. | Other | Active Program Participant |
Primary outcome
Post-Traumatic Growth
Time frame: 12 weeks
We will use the Current-Standing Post-Traumatic Growth Inventory (C-PTGI)
Depression
Time frame: 12 weeks
We will use the Patient Health Questionnaire-8 (PHC-8)
Anxiety
Time frame: 12 weeks
We will use the Generalized Anxiety Disorder 7-item Scale (GAD-7)
Wellbeing
Time frame: 12 weeks
We will use Mental Health Checklist-Short Form (MHC-SF)
Vulnerability
Time frame: 12 weeks
We will use the Multidimensional Scale of Perceived Social Support (MSPSS)
Wisdom
Time frame: 12 weeks
We will use the Claremont Purpose Scale
Strength
Time frame: 12 weeks
We will use the State Hope Scale
Morality
Time frame: 12 weeks
We will use the Compassion Scale
Narrative Identity
Time frame: 12 weeks
We will code short qualitative responses for Personal Growth, Meaning-Making, Resolution, and Emotional Processing (Positive Reframing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eranda Jayawickreme, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program to Support Well-Being after Adversity in people with Trauma and Distress, Emotional, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casey Keller, MA (336-758-5786, kellerc@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Growth (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.