Suicidal IdeationNCT05351645
Digital Narrative Bibliotherapy as a Scalable Intervention for Suicidal Thoughts
A study testing Treatment in people with Suicidal Ideation, run by Harvard University at 1 site in United States.
Trial summary
The goal of this study was to determine whether reading about others' experiences with suicide can help reduce suicidal thoughts. To investigate this issue, the investigators recruited users from an internet support community. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 14 Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or above
- English as primary language
- Having thought about suicide in the past 12 months
Who cannot join
- a high level of suicide intent (as indicated by a 7 or greater on a 10-point scale of intent to act on suicidal thoughts)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Narrative Bibliotherapy as a Scalable Intervention for Suicidal Thoughts: A Randomized Controlled Trial (Testing Whether Selected Blog Posts Can Improve Well-being)
The goal of this study was to determine whether reading about others' experiences with suicide can help reduce suicidal thoughts. To investigate this issue, the investigators recruited users from an internet support community. The investigators randomized participants to two separate groups: a Treatment group and a Control group. Participants in the treatment group read one first-person narrative about suicide each day for 14 days, and answered questions before and after reading the narrative. Participants in the Control group answered questions once per day during the 14-day trial period and did not receive the narrative intervention until after the initial study ended. All participants completed a follow-up questionnaire two weeks after the end of the 14-day trial period.
Read the detailed description
BACKGROUND In the US, suicide is the 10th leading cause of death among all age groups, and the second leading cause of death of individuals 14 to 34. Despite the enormity of this public health concern, scientific progress has not led to lasting reductions in the suicide rate, which in 2019 was nearly identical to that in the US 100 years prior. Looking beyond the scope of traditional medicine and psychotherapy to identify novel treatments may be critical for improving our ability to ameliorate the problem of suicide.
Scholars have discussed the act of reading as an effective treatment for psychiatric concerns, a concept within narrative therapy known as bibliotherapy, for centuries. Studies investigating the effectiveness of bibliotherapy have found that reading about others' experiences with struggles can be therapeutic. For example, bibliotherapy has been shown to improve hopefulness, reduce symptoms of anxiety, and reduce depressive symptoms. Only a small number of studies have examined narrative-based bibliotherapy as a therapeutic tool to help those struggling with suicidal thoughts, and of these sample sizes are small. However, one such study found that bibliotherapy significantly reduced the number of suicide attempts and nonsuicidal self-harm episodes among adolescents and adults who had recently received treatment for these behaviors. Another such study found that bibliotherapy conducted adjunctively with traditional psychotherapy for depressed adults significantly reduced suicidal ideation for three months following the intervention.
Bibliotherapy has numerous practical benefits when compared with traditional psychotherapies. It is low-cost, brief, and can be conducted easily when face-to-face interventions are not plausible, such as during the current COVID-19 pandemic. The positive effects of bibliotherapy are also generally long-lasting, persisting for anywhere between 3 months and 3 years. Further, bibliotherapy has been shown to be as effective as face-to-face psychotherapy for reducing depression and anxiety symptoms in one large systematic review. Finally, bibliotherapy is shown to normalize the experience of mental health struggles, thereby reducing stigma and allowing patients to feel that they are not alone. Due to the lack of large-scale randomized controlled trials examining the effectiveness of bibliotherapy, there may be additional unknown benefits to this practice, perhaps especially in easily-scalable, online peer-to-peer modalities, as with the present study.
Three key aspects of suicide-related narrative bibliotherapy may be particularly beneficial to those struggling with suicidal thoughts. For one, the first-person perspective of narrative content conveys experiential knowledge about a subject area that is not often discussed openly. By sharing a first-hand experience with challenges, the author of the narrative can communicate specific challenges to be overcome, identify gaps in the reader's knowledge, propose strategies that were beneficial, and provide the reader with a plan for recovery. In doing so, suicide narratives, especially those that showcase recovery-related behaviors and activities (e.g., seeking support), could help people by illustrating the possibility of recovery. Indeed, inspiring optimism is shown to be a key benefit of narrative-sharing for individuals experiencing psychological distress.
Second, suicide narratives may lead to improvements in mental health and wellbeing by increasing social connectedness to a broader community. This may be especially important for suicidal people who face stigma and social isolation that may further exacerbate distress. Moreover, improving connectedness may be critical in remediating problems associated with social isolation caused by the COVID-19 pandemic.
Third, narratives are implicitly engaging and naturally constructed to make sense of complex circumstances and emotions. Narrative-based bibliotherapy may therefore hold particular value in healthcare communications and in interventions for which patients are expected to learn and apply new knowledge, skills, or behavioral strategies. Likewise, bibliotherapy may be able to support patients' abilities to verbalize their thoughts and feelings by helping these individuals develop a semantic representation of complex psychological processes.
Recently, a growing number of studies have revealed therapeutic benefits of digital mental health resources for people at risk for suicide. Such resources include peer-to-peer internet support networks, web-based individual psychotherapy platforms, and smartphone apps designed to improve the user's sense of self worth. The internet may be a fruitful domain for the development of new suicide interventions, as people with suicidal thoughts may be more likely to seek support online to avoid stigma, readily available methods for the detection of suicide-related discussions online have been validated, and digital interventions can reach a broader population more easily than traditional psychotherapies, including those unable or unwilling to attend in-person appointments. In short, society is in need of effective suicide interventions that are low-cost, engaging, and highly scalable, and internet-based resources seem poised to host such interventions.
Social media platforms provide an opportunity for users to discuss their experiences with mental health difficulties and allow other users to read, comment on, and share these stories with others at no monetary cost. People with suicidal thoughts, behaviors, and related self-injurious concerns tend to utilize social media platforms as a way to communicate and find information about these concerns. The content posted on these platforms, therefore, represents an opportunity to explore whether this form of digital bibliotherapy can help people struggling with suicide. Several recent studies have provided preliminary evidence that digital bibliotherapies can be beneficial for suicidal thoughts. However, many of these studies are qualitative in nature, all examined small sample sizes, and none to our knowledge have employed a randomized controlled design to systematically examine the influence of narrative bibliotherapy on suicidal thoughts.
In the present study, the investigators aimed to fill this gap in the field's knowledge by testing whether reading user-generated stories about suicide posted to a digital social media platform leads to a reduction in the suicidal thoughts of at-risk individuals. The investigators further aimed to test whether such stories are beneficial for people experiencing suicidal thoughts by helping these individuals feel more optimistic (less hopeless) and more connected to others (less isolated).
PARTICIPANTS \& RECRUITMENT
Participants were recruited from the web platform, The Mighty, an online community dedicated to supporting those who face health challenges. Users of The Mighty can subscribe to content posted within sub-communities organized by specific challenges. Website moderators placed a "popup" advertisement for this study on pages that featured content about and related to suicide. Interested users, who had already established a user account with The Mighty, completed an online screening questionnaire that assessed age, race/ethnicity, history of suicidal thoughts, and current intent to act on suicidal thoughts. Participants qualified if they were age 18 or above, reported English as their primary language, thought about suicide in the past year, and reported current suicidal intent of six or lower on a 10-point scale. Eight hundred sixty-four participants met screening criteria and provided informed consent. Of this group, a final sample of 528 participants completed at least one survey including the main outcome of interest, desire to die, during the trial period. Participants were randomized into one of two study groups after providing informed consent, a Treatment condition and a Control condition.
TRIAL PROCEDURES All trial procedures were approved by the Harvard University Institutional Review Board. Qualified participants received instructions about all study procedures by email prior to beginning the trial. Participants randomized to the Treatment condition received one email each day during a 14-day trial period. The email contained a link, which first asked participants to complete a three-item survey assessing self-reported feelings of (a) connectedness, (b) hopefulness, and (c) desire to die. Treatment condition participants were then instructed to read a single user-generated narrative about suicide, confirm the narrative was read, and finally complete the same three-item survey again. Participants in the Control condition received one email each day during the 14-day trial period that contained the three-item survey assessing connectedness, hopefulness, and desire to die only. Participants responded to all survey items using an 10-point Likert-type scale ranging from 1 ("not at all") to 10 ("definitely").
Two weeks after the conclusion of the 14-day trial period, participants in both the Treatment and Control conditions were asked to complete the three-item survey assessing connectedness, hopefulness, and desire to die. After completing the follow-up survey, participants in the Control condition received the same suicide narrative bibliotherapy intervention provided to those in the Treatment condition.
The 14 narratives provided to participants in the Treatment condition each described first-hand experiences with suicidal thoughts and behaviors and highlighted a range of issues related to the authors' struggles. This set of 14 narratives was selected based on pilot research suggesting that they were associated with reductions in suicidal thoughts, included a positive conclusion (e.g., the author discussed recovery), and described the experience of struggle in a relatable way (e.g., "feeling this way is common").
HYPOTHESES The authors tested four a priori hypotheses. First, the authors hypothesized that participants receiving the digital bibliotherapy intervention (treatment condition) would report lower desire to die over the course of the trial period than participants on the waitlist (control condition). Second, the authors hypothesized that the effect of the treatment would be maintained at the 2-week follow-up period. Third, the authors hypothesized that participants assigned to the treatment condition who completed more days of the trial would report lower desire to die (i.e., dose response effect). Fourth, the authors hypothesized that reductions in suicidal thoughts for participants who received the digital bibliotherapy intervention (treatment condition) would be mediated by increased perceptions of connectedness and increased feelings of optimism.
- Conditions
- Suicidal Ideation
- Being tested
- Treatment
- Keywords
- Suicide, suicidal ideation, daily diary, randomized controlled trial
- Medical subject headings
- Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
Once per day for a 14-day trial period, participants in the Treatment group were assigned to read a first-person narrative about a past issue with suicidal thoughts or behaviors. These narratives each contained positive elements, such as providing details about how the author had overcome issues with suicide, suggesting that people with suicidal thought are "not alone," or encouraging people with suicidal thoughts/behaviors to have hope.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Participants in the Treatment arm were assigned to read one each day during the two-week trial period. These articles described a personal experience suicide from a first-person perspective, and included positive messages. Before and after reading these articles, participants in the Treatment arm answered brief questions assessing current suicidal thoughts and other constructs. Participants in the Treatment group were administered follow-up questionnaires 14 days after the completion of the trial period to assess suicidal thoughts and other constructs. Receives: Behavioral: Treatment |
| Control | No intervention | Participants in the Control arm answered questionnaires one time per day assessing suicidal thoughts and among other constructs (the same items as the Treatment group) during the two-week trial. Control participants did not receive the positive suicide related stories during the two-week trial period. Participants in the control group completed follow-up questionnaires 14 days after the completion of the trial period to assess suicidal thoughts and other constructs (the same items as the Treatment group). After the follow-up phase was complete, participants in the Control group received the same intervention as those in the Treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Thoughts
Participants self-reported their current desire to die on a Likert-type scale. Responses were made using a 9-point Likert-type scale ranging from 1 (not at all) to 10 (definitely). Higher scores indicate higher feelings of suicidal thoughts.
Measured: 14-day trial period with a follow-up assessment two weeks later
Secondary outcomes (2)
Optimism
Participants self-reported their feelings of optimism (like the problems they have might get better). Responses were made using a 9-point Likert-type scale ranging from 1 (not at all) to 10 (definitely). Higher scores indicate higher feelings of optimism.
Measured: 14-day trial period with a follow-up assessment two weeks later
Connectedness
Participants self-reported their feelings of being connected to others (like they are not the only ones with their problems). Responses were made using a 9-point Likert-type scale ranging from 1 (not at all) to 10 (definitely). Higher scores indicate higher feelings of connectedness.
Measured: 14-day trial period with a follow-up assessment two weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Nov 2020
- Primary completion14 Mar 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants were randomized to one of two groups (Treatment and Control) after providing informed consent. Participants in the Treatment group received the digital bibliotherapy intervention, and participants in the Control group were assigned to a waitlist.
- Masking
- None (open label)
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Franz, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351645
- Sponsor's protocol ID
- IRB19-0843
- Status last verified
- Apr 2022
- First submitted
- 11 Jan 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because data were collected with the help of a private organization, authors will make a determination about sharing of data on a case-by-case basis, in consultation with the organization
Publications
Akhouri, D. (2018). Bibliotherapy as a Self Management Method to Treat Mild to Moderate Level of Depression. International Journal of Research in Social Sciences. Vol. 8 Issue 7, July 2018.
Anderson L, Lewis G, Araya R, Elgie R, Harrison G, Proudfoot J, Schmidt U, Sharp D, Weightman A, Williams C. Self-help books for depression: how can practitioners and patients make the right choice? Br J Gen Pract. 2005 May;55(514):387-92.
PubMed 15904559Berkley-Patton J, Goggin K, Liston R, Bradley-Ewing A, Neville S. Adapting effective narrative-based HIV-prevention interventions to increase minorities' engagement in HIV/AIDS services. Health Commun. 2009 Apr;24(3):199-209. doi: 10.1080/10410230902804091.
PubMed 19415552Berry N, Lobban F, Belousov M, Emsley R, Nenadic G, Bucci S. #WhyWeTweetMH: Understanding Why People Use Twitter to Discuss Mental Health Problems. J Med Internet Res. 2017 Apr 5;19(4):e107. doi: 10.2196/jmir.6173.
PubMed 28381392Betzalel, N., & Shechtman, Z. (2017). The impact of bibliotherapy superheroes on youth who experience parental absence. School Psychology International, 38(5), 473-490.
Bietti LM, Tilston O, Bangerter A. Storytelling as Adaptive Collective Sensemaking. Top Cogn Sci. 2019 Oct;11(4):710-732. doi: 10.1111/tops.12358. Epub 2018 Jun 28.
PubMed 29954043Booker, J.A., & Dunsmore, J.C.. (2017). Expressive Writing and Well-Being During the Transition to College: Comparison of Emotion-Disclosing and Gratitude-Focused Writing Jordan A. Journal of Social and Clinical Psychology. 36(7), 580-606.
Bower P, Richards D, Lovell K. The clinical and cost-effectiveness of self-help treatments for anxiety and depressive disorders in primary care: a systematic review. Br J Gen Pract. 2001 Oct;51(471):838-45.
PubMed 11677710Centers for Disease Control and Prevention: National Center for Injury Prevention and Control. (2019). 10 Leading Causes of Death, United States. Retrieved from www.cdc.gov/ncipc/wisqars
Crimp, D. (1987) How to have promiscuity in an epidemic. AIDS: Cultural Analysis/Cultural Activism, 43: 237-271. Https:// doi:10.2307/3397576
Cuijpers P. Bibliotherapy in unipolar depression: a meta-analysis. J Behav Ther Exp Psychiatry. 1997 Jun;28(2):139-47. doi: 10.1016/s0005-7916(97)00005-0.
PubMed 9194011Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.
PubMed 20406528Curtin, S.C., Warner, M. (2016). Increase in Suicide in the United States, 1999-2014. National Center for Health Statistics, Center for Disease Control.
Davies F, Shepherd HL, Beatty L, Clark B, Butow P, Shaw J. Implementing Web-Based Therapy in Routine Mental Health Care: Systematic Review of Health Professionals' Perspectives. J Med Internet Res. 2020 Jul 23;22(7):e17362. doi: 10.2196/17362.
PubMed 32706713Eichenberg C. Internet message boards for suicidal people: a typology of users. Cyberpsychol Behav. 2008 Feb;11(1):107-13. doi: 10.1089/cpb.2007.9924.
PubMed 18275323
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Narrative Bibliotherapy as a Scalable Intervention for Suicidal Thoughts: A Randomized Controlled Trial (Testing Whether Selected Blog Posts Can Improve Well-being)
- ClinicalTrials.gov ID
- NCT05351645
- Acronym / sponsor ID
- IRB19-0843
- Conditions
- Suicidal Ideation
- Keywords
- Suicide, suicidal ideation, daily diary, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 28 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.
The goal of this study was to determine whether reading about others' experiences with suicide can help reduce suicidal thoughts. To investigate this issue, the investigators recruited users from an internet support community. The investigators randomized participants to two separate groups: a Treatment group and a Control group. Participants in the treatment group read one first-person narrative about suicide each day for 14 days, and answered questions before and after reading the narrative. Participants in the Control group answered questions once per day during the 14-day trial period and did not receive the narrative intervention until after the initial study ended. All participants completed a follow-up questionnaire two weeks after the end of the 14-day trial period.
Detailed description
BACKGROUND In the US, suicide is the 10th leading cause of death among all age groups, and the second leading cause of death of individuals 14 to 34. Despite the enormity of this public health concern, scientific progress has not led to lasting reductions in the suicide rate, which in 2019 was nearly identical to that in the US 100 years prior. Looking beyond the scope of traditional medicine and psychotherapy to identify novel treatments may be critical for improving our ability to ameliorate the problem of suicide.
Scholars have discussed the act of reading as an effective treatment for psychiatric concerns, a concept within narrative therapy known as bibliotherapy, for centuries. Studies investigating the effectiveness of bibliotherapy have found that reading about others' experiences with struggles can be therapeutic. For example, bibliotherapy has been shown to improve hopefulness, reduce symptoms of anxiety, and reduce depressive symptoms. Only a small number of studies have examined narrative-based bibliotherapy as a therapeutic tool to help those struggling with suicidal thoughts, and of these sample sizes are small. However, one such study found that bibliotherapy significantly reduced the number of suicide attempts and nonsuicidal self-harm episodes among adolescents and adults who had recently received treatment for these behaviors. Another such study found that bibliotherapy conducted adjunctively with traditional psychotherapy for depressed adults significantly reduced suicidal ideation for three months following the intervention.
Bibliotherapy has numerous practical benefits when compared with traditional psychotherapies. It is low-cost, brief, and can be conducted easily when face-to-face interventions are not plausible, such as during the current COVID-19 pandemic. The positive effects of bibliotherapy are also generally long-lasting, persisting for anywhere between 3 months and 3 years. Further, bibliotherapy has been shown to be as effective as face-to-face psychotherapy for reducing depression and anxiety symptoms in one large systematic review. Finally, bibliotherapy is shown to normalize the experience of mental health struggles, thereby reducing stigma and allowing patients to feel that they are not alone. Due to the lack of large-scale randomized controlled trials examining the effectiveness of bibliotherapy, there may be additional unknown benefits to this practice, perhaps especially in easily-scalable, online peer-to-peer modalities, as with the present study.
Three key aspects of suicide-related narrative bibliotherapy may be particularly beneficial to those struggling with suicidal thoughts. For one, the first-person perspective of narrative content conveys experiential knowledge about a subject area that is not often discussed openly. By sharing a first-hand experience with challenges, the author of the narrative can communicate specific challenges to be overcome, identify gaps in the reader's knowledge, propose strategies that were beneficial, and provide the reader with a plan for recovery. In doing so, suicide narratives, especially those that showcase recovery-related behaviors and activities (e.g., seeking support), could help people by illustrating the possibility of recovery. Indeed, inspiring optimism is shown to be a key benefit of narrative-sharing for individuals experiencing psychological distress.
Second, suicide narratives may lead to improvements in mental health and wellbeing by increasing social connectedness to a broader community. This may be especially important for suicidal people who face stigma and social isolation that may further exacerbate distress. Moreover, improving connectedness may be critical in remediating problems associated with social isolation caused by the COVID-19 pandemic.
Third, narratives are implicitly engaging and naturally constructed to make sense of complex circumstances and emotions. Narrative-based bibliotherapy may therefore hold particular value in healthcare communications and in interventions for which patients are expected to learn and apply new knowledge, skills, or behavioral strategies. Likewise, bibliotherapy may be able to support patients' abilities to verbalize their thoughts and feelings by helping these individuals develop a semantic representation of complex psychological processes.
Recently, a growing number of studies have revealed therapeutic benefits of digital mental health resources for people at risk for suicide. Such resources include peer-to-peer internet support networks, web-based individual psychotherapy platforms, and smartphone apps designed to improve the user's sense of self worth. The internet may be a fruitful domain for the development of new suicide interventions, as people with suicidal thoughts may be more likely to seek support online to avoid stigma, readily available methods for the detection of suicide-related discussions online have been validated, and digital interventions can reach a broader population more easily than traditional psychotherapies, including those unable or unwilling to attend in-person appointments. In short, society is in need of effective suicide interventions that are low-cost, engaging, and highly scalable, and internet-based resources seem poised to host such interventions.
Social media platforms provide an opportunity for users to discuss their experiences with mental health difficulties and allow other users to read, comment on, and share these stories with others at no monetary cost. People with suicidal thoughts, behaviors, and related self-injurious concerns tend to utilize social media platforms as a way to communicate and find information about these concerns. The content posted on these platforms, therefore, represents an opportunity to explore whether this form of digital bibliotherapy can help people struggling with suicide. Several recent studies have provided preliminary evidence that digital bibliotherapies can be beneficial for suicidal thoughts. However, many of these studies are qualitative in nature, all examined small sample sizes, and none to our knowledge have employed a randomized controlled design to systematically examine the influence of narrative bibliotherapy on suicidal thoughts.
In the present study, the investigators aimed to fill this gap in the field's knowledge by testing whether reading user-generated stories about suicide posted to a digital social media platform leads to a reduction in the suicidal thoughts of at-risk individuals. The investigators further aimed to test whether such stories are beneficial for people experiencing suicidal thoughts by helping these individuals feel more optimistic (less hopeless) and more connected to others (less isolated).
PARTICIPANTS \& RECRUITMENT
Participants were recruited from the web platform, The Mighty, an online community dedicated to supporting those who face health challenges. Users of The Mighty can subscribe to content posted within sub-communities organized by specific challenges. Website moderators placed a "popup" advertisement for this study on pages that featured content about and related to suicide. Interested users, who had already established a user account with The Mighty, completed an online screening questionnaire that assessed age, race/ethnicity, history of suicidal thoughts, and current intent to act on suicidal thoughts. Participants qualified if they were age 18 or above, reported English as their primary language, thought about suicide in the past year, and reported current suicidal intent of six or lower on a 10-point scale. Eight hundred sixty-four participants met screening criteria and provided informed consent. Of this group, a final sample of 528 participants completed at least one survey including the main outcome of interest, desire to die, during the trial period. Participants were randomized into one of two study groups after providing informed consent, a Treatment condition and a Control condition.
TRIAL PROCEDURES All trial procedures were approved by the Harvard University Institutional Review Board. Qualified participants received instructions about all study procedures by email prior to beginning the trial. Participants randomized to the Treatment condition received one email each day during a 14-day trial period. The email contained a link, which first asked participants to complete a three-item survey assessing self-reported feelings of (a) connectedness, (b) hopefulness, and (c) desire to die. Treatment condition participants were then instructed to read a single user-generated narrative about suicide, confirm the narrative was read, and finally complete the same three-item survey again. Participants in the Control condition received one email each day during the 14-day trial period that contained the three-item survey assessing connectedness, hopefulness, and desire to die only. Participants responded to all survey items using an 10-point Likert-type scale ranging from 1 ("not at all") to 10 ("definitely").
Two weeks after the conclusion of the 14-day trial period, participants in both the Treatment and Control conditions were asked to complete the three-item survey assessing connectedness, hopefulness, and desire to die. After completing the follow-up survey, participants in the Control condition received the same suicide narrative bibliotherapy intervention provided to those in the Treatment condition.
The 14 narratives provided to participants in the Treatment condition each described first-hand experiences with suicidal thoughts and behaviors and highlighted a range of issues related to the authors' struggles. This set of 14 narratives was selected based on pilot research suggesting that they were associated with reductions in suicidal thoughts, included a positive conclusion (e.g., the author discussed recovery), and described the experience of struggle in a relatable way (e.g., "feeling this way is common").
HYPOTHESES The authors tested four a priori hypotheses. First, the authors hypothesized that participants receiving the digital bibliotherapy intervention (treatment condition) would report lower desire to die over the course of the trial period than participants on the waitlist (control condition). Second, the authors hypothesized that the effect of the treatment would be maintained at the 2-week follow-up period. Third, the authors hypothesized that participants assigned to the treatment condition who completed more days of the trial would report lower desire to die (i.e., dose response effect). Fourth, the authors hypothesized that reductions in suicidal thoughts for participants who received the digital bibliotherapy intervention (treatment condition) would be mediated by increased perceptions of connectedness and increased feelings of optimism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to one of two groups (Treatment and Control) after providing informed consent. Participants in the Treatment group received the digital bibliotherapy intervention, and participants in the Control group were assigned to a waitlist.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Behavioral: TreatmentParticipants in the Treatment arm were assigned to read one each day during the two-week trial period. These articles described a personal experience suicide from a first-person perspective, and included positive messages. Before and after reading these articles, participants in the Treatment arm answered brief questions assessing current suicidal thoughts and other constructs. Participants in the Treatment group were administered follow-up questionnaires 14 days after the completion of the trial period to assess suicidal thoughts and other constructs. |
| Control | No intervention | –Participants in the Control arm answered questionnaires one time per day assessing suicidal thoughts and among other constructs (the same items as the Treatment group) during the two-week trial. Control participants did not receive the positive suicide related stories during the two-week trial period. Participants in the control group completed follow-up questionnaires 14 days after the completion of the trial period to assess suicidal thoughts and other constructs (the same items as the Treatment group). After the follow-up phase was complete, participants in the Control group received the same intervention as those in the Treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above
- English as primary language
- Having thought about suicide in the past 12 months
Key exclusion criteria (1 listed)
- a high level of suicide intent (as indicated by a 7 or greater on a 10-point scale of intent to act on suicidal thoughts)
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 |
|---|---|---|
| TreatmentOnce per day for a 14-day trial period, participants in the Treatment group were assigned to read a first-person narrative about a past issue with suicidal thoughts or behaviors. These narratives each contained positive elements, such as providing details about how the author had overcome issues with suicide, suggesting that people with suicidal thought are "not alone," or encouraging people with suicidal thoughts/behaviors to have hope. | Behavioural | Treatment |
Primary outcome
Suicidal Thoughts
Time frame: 14-day trial period with a follow-up assessment two weeks later
Participants self-reported their current desire to die on a Likert-type scale. Responses were made using a 9-point Likert-type scale ranging from 1 (not at all) to 10 (definitely). Higher scores indicate higher feelings of suicidal thoughts.
2 secondary outcomes
Optimism
Time frame: 14-day trial period with a follow-up assessment two weeks later
Connectedness
Time frame: 14-day trial period with a follow-up assessment two weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- BackgroundAkhouri, D. (2018). Bibliotherapy as a Self Management Method to Treat Mild to Moderate Level of Depression. International Journal of Research in Social Sciences. Vol. 8 Issue 7, July 2018.
- Background: PubMed 15904559Anderson L, Lewis G, Araya R, Elgie R, Harrison G, Proudfoot J, Schmidt U, Sharp D, Weightman A, Williams C. Self-help books for depression: how can practitioners and patients make the right choice? Br J Gen Pract. 2005 May;55(514):387-92.
- Background: PubMed 19415552Berkley-Patton J, Goggin K, Liston R, Bradley-Ewing A, Neville S. Adapting effective narrative-based HIV-prevention interventions to increase minorities' engagement in HIV/AIDS services. Health Commun. 2009 Apr;24(3):199-209. doi: 10.1080/10410230902804091.
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- Individual participant dataSharing planned: Yes. Because data were collected with the help of a private organization, authors will make a determination about sharing of data on a case-by-case basis, in consultation with the organization
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Suicidal Ideation, run by Harvard 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 3 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 28 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?
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?
Suicidal Thoughts (time frame: 14-day trial period with a follow-up assessment two weeks later). 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 NCT05351645, which also lists 48 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 28 Apr 2022.