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BereavementNCT05352243

Bereaved Young Adults Study

A study testing Expressive Disclosure, Expressive Helping and Fact-Writing in people with Bereavement, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bereaved adolescents and emerging adults are at risk for developing psychological disorders and complicated grief. Clinical grief interventions and conventional wisdom reflect an implicit assumption that sharing and expressing one's feelings surrounding a loss (i.e., emotional disclosure) facilitates psychological… Read more about this study

Who is it for?
Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Bereavement
What is being tested?
Expressive Disclosure, Expressive Helping and Fact-Writing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
1 siteUnited States
Study dates
24 Jan 2022to 1 Sep 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 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Experienced the death of a loved one within the last 5 years, but more than 6 months ago.
  • Endorse having close relationship with loved one at time of their death (i.e., 5 or above on 1-10 likert scale with 1 being not at all close, and 10 being extremely close).
  • Endorse moderate to severe distress about the loss (i.e., 5 or above on 1-10 likert scale with 1 being not at all distressed, and 10 being extremely distressed).
  • Feel comfortable writing in English (due to the linguistic nature of the writing sessions).
  • Have access to the Internet and a computer to complete the assessments and writing sessions.

Who cannot join

  • 1. Express active psychosis or suicidal ideation, or any other circumstances that, in the opinion of the investigators, compromise participant safety.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Combined Expressive Disclosure and Prosocial Writing to Promote Well-Being and Decrease Psychological Distress Among Bereaved Emerging Adults: Examining The Roles of Psychological Distancing, Universality, and Generativity

Bereaved adolescents and emerging adults are at risk for developing psychological disorders and complicated grief. Clinical grief interventions and conventional wisdom reflect an implicit assumption that sharing and expressing one's feelings surrounding a loss (i.e., emotional disclosure) facilitates psychological adjustment. However, studies of emotional disclosure have yielded null results in bereaved samples. Individuals who have encountered stressful life events, including interpersonal loss, often report a desire to "give back" to others in similar situations. Empirical evidence suggests that providing support to others can be equally, if not more, beneficial than receiving support. The opportunity to support others experiencing stressful circumstances may address common feelings of powerlessness and engender a sense of meaning, enhancing positive affect and reducing distress. Interventions that leverage prosocial behaviors are associated with positive effects, including increases in wellbeing in non-bereaved populations. To date, no research has examined the utility of prosocial interventions for bereaved individuals.

The present study tests a novel expressive helping intervention that combines elements of expressive disclosure and prosocial writing. Expressive helping will be compared to traditional expressive disclosure and a neutral writing control condition in a sample of bereaved young adults. Participants (N=156) will be randomized to one of three conditions-expressive disclosure, expressive helping, or a neutral writing control-and complete three weekly 20-minute writing sessions. Measures of psychological distress, well-being, and hypothesized mediators will be administered before, immediately following (within 48 hours of the final writing session), one month, and two months after the writing sessions. It is hypothesized that the participants in the expressive helping condition will evidence greater increases in well-being and decreases in grief-related distress at the one and two-month follow-ups, as compared to the other two groups.

Conditions
Bereavement
Being tested
Expressive Disclosure, Expressive Helping, Fact-Writing
Keywords
Expressive Disclosure, Prosocial, Expressive Writing, Peer Helping, Young Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive DisclosureBehavioural

    Prior to each writing session, participants will receive general instructions for completing the writing (e.g., write continuously for 20 minutes, do not worry about grammar, sentence structure, repetition), and be reminded that their writing will remain confidential. Three writing sessions will be spaced 1-2 weeks apart. A weekly writing prompt will instruct participants to write about their deepest thoughts and feelings surrounding their bereavement experience.

  • Expressive HelpingBehavioural

    Prior to each writing session, participants will receive general instructions for completing the writing (e.g., write continuously for 20 minutes, do not worry about grammar, sentence structure, repetition), and be reminded that their first two writing will remain confidential, and their final essay will be de-identified before being provided to newly bereaved young adults. Three writing sessions will be spaced 1-2 weeks apart. In the first two writing sessions, participants will receive a writing prompt that will instruct them to write about their deepest thoughts and feelings surrounding their bereavement experience. For the final writing session, participants will receive a writing prompt instructing them to provide advice and support for a newly bereaved young adult.

  • Fact-WritingBehavioural

    Prior to each writing session, participants will receive general instructions for completing the writing (e.g., write continuously for 20 minutes, do not worry about grammar, sentence structure, repetition), and be reminded that their writing will remain confidential. Three writing sessions will be spaced 1-2 weeks apart. A weekly writing prompt will instruct participants to write objectively about different time frames (e.g., routine for getting up in the morning, routine for going to sleep at night).

Study groups in NCT05352243
Study groupRoleWhat they receive
Expressive DisclosureActive comparatorParticipants will be instructed to write about their deepest thoughts and feelings surrounding their bereavement experience.
Receives: Behavioral: Expressive Disclosure
Expressive HelpingExperimentalParticipants will be instructed to write about their deepest thoughts and feeling surrounding their bereavement experience in their first two essays and to provide advice and support for someone who recently experienced a loss in their final essay.
Receives: Behavioral: Expressive Helping
Fact-WritingSham comparatorParticipants will be instructed to write objectively about different time frames (e.g., routine for getting up in the morning, routine for going to sleep at night).
Receives: Behavioral: Fact-Writing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Wellbeing

    Wellbeing within the past two weeks will be measured at baseline, post-intervention, and the 1-month follow-up via the 14-item Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.

    Measured: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.

  2. Change in Grief Reactions

    Grief-related distress within the past two weeks will be measured using the 18-item Traumatic-Grief Inventory Self-Report version (TGI-SR; Boelen et al., 2019). The TGI-SR includes items that reflect the criteria for Prolonged Grief Disorder (PGD) and Persistent Complex Bereavement Disorder set forth by the Diagnostic and Statistical Manual of Mental Disorders and International Classification of Diseases, respectively. Higher scores (range: 18-90) indicate more severe potentially impairing grief reactions.

    Measured: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.

Secondary outcomes (3)
  1. Change in Physical Symptoms

    Physical symptoms within the past two weeks will be measured using the Pennebaker Inventory of Limbic Languidness (PILL; Pennebaker et al., 1982). The PILL contains 54 items measured using a 5-point scale for the frequency of a variety of common physical symptoms (1 = never, 5 = more than once every week). Higher total scores (range, 0-216) indicate greater symptomatology.

    Measured: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.

  2. Change in Anxiety

    Anxiety symptoms over the past 2 weeks will be measured using the 7-item PROMIS - Anxiety Short Form (Pilkonis, 2011). Higher scores (range: 7-35) on this scale indicate greater severity of anxiety symptoms.

    Measured: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.

  3. Change in Depressive Symptoms

    Depressive symptoms over the past two weeks will be measured using the 20-item Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977). The CES-D is a measure of symptom severity. Higher scores (range: 0-60) on this scale indicate greater depressive symptom severity.

    Measured: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start24 Jan 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352243
Sponsor's protocol ID
21-001728
Status last verified
May 2023
First submitted
22 Apr 2022
Last updated
16 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ayduk O, Kross E. From a distance: implications of spontaneous self-distancing for adaptive self-reflection. J Pers Soc Psychol. 2010 May;98(5):809-29. doi: 10.1037/a0019205.

    PubMed 20438226
  • Boelen PA, Djelantik AAAMJ, de Keijser J, Lenferink LIM, Smid GE. Further validation of the Traumatic Grief Inventory-Self Report (TGI-SR): A measure of persistent complex bereavement disorder and prolonged grief disorder. Death Stud. 2019;43(6):351-364. doi: 10.1080/07481187.2018.1480546. Epub 2018 Jul 17.

    PubMed 30015568
  • Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.

    PubMed 2926629
  • Eisenberg SA, Shen BJ, Schwarz ER, Mallon S. Avoidant coping moderates the association between anxiety and patient-rated physical functioning in heart failure patients. J Behav Med. 2012 Jun;35(3):253-61. doi: 10.1007/s10865-011-9358-0. Epub 2011 Jun 10.

    PubMed 21660588
  • Gruenewald TL, Tanner EK, Fried LP, Carlson MC, Xue QL, Parisi JM, Rebok GW, Yarnell LM, Seeman TE. The Baltimore Experience Corps Trial: Enhancing Generativity via Intergenerational Activity Engagement in Later Life. J Gerontol B Psychol Sci Soc Sci. 2016 Jul;71(4):661-70. doi: 10.1093/geronb/gbv005. Epub 2015 Feb 25.

    PubMed 25721053
  • Keyes, C. L. M. (2009). Atlanta: Brief description of the mental health continuum short form (MHC-SF).

  • Libby LK, Eibach RP. Looking back in time: self-concept change affects visual perspective in autobiographical memory. J Pers Soc Psychol. 2002 Feb;82(2):167-79.

    PubMed 11831407
  • Pennebaker JW, Gonder-Frederick L, Stewart H, Elfman L, Skelton JA. Physical symptoms associated with blood pressure. Psychophysiology. 1982 Mar;19(2):201-10. doi: 10.1111/j.1469-8986.1982.tb02547.x. No abstract available.

    PubMed 7071299
  • Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

    PubMed 21697139
  • Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401.

  • Ross M, Wilson AE. It feels like yesterday: self-esteem, valence of personal past experiences, and judgments of subjective distance. J Pers Soc Psychol. 2002 May;82(5):792-803.

    PubMed 12003478
  • Stanton AL, Kirk SB, Cameron CL, Danoff-Burg S. Coping through emotional approach: scale construction and validation. J Pers Soc Psychol. 2000 Jun;78(6):1150-69. doi: 10.1037//0022-3514.78.6.1150.

    PubMed 10870915
  • Weinberg, N., Uken, J. S., Schmale, J., & Adamek, M. (1995). Therapeutic factors: Their presence in a computer-mediated support group. Social Work with Groups, 18, 57-69.

  • Yalom, I. D. (1995). The theory and practice of group psychotherapy. Basic Books.

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Disclosure, Expressive Helping and Fact-Writing in people with Bereavement, run by University of California, Los Angeles 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 1 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: finished, as of the sponsor's last update on 16 May 2023. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wellbeing (time frame: Baseline (≤2 weeks of starting the intervention), post-intervention survey (≤1 week after the final writing assignment), the 1-month follow-up, and 2-month follow up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352243, which also lists 14 linked publications.

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 16 May 2023.

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