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Suicidal IdeationNCT06225531

An Autobiographical Memory-Based Intervention for Suicidality

A study testing Autobiographical Memory Based Intervention in people with Suicidal Ideation and Mental Health Disorder, run by Lancaster University at 1 site in United Kingdom.

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

The study involves a short therapy intervention for people who are experiencing thoughts of suicide. The intervention will focus upon different memories from the person's life. These memories will vary in the emotions they evoke - some memories will be associated with neutral emotions, whereas others will bring up… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Suicidal Ideation, Mental Health Disorder
What is being tested?
Autobiographical Memory Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited Kingdom
Study dates
15 May 2024to 21 Aug 2024
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individual has experienced suicidal ideation and/or suicidal behaviours within the previous 3 months. This will be screened for by asking the questions:
  • Have you had thoughts or images of ending your life within the past three months? or
  • Have you attempted to end your life within the past 3 months?
  • Currently under a Community Mental Health Team (CMHT) within which supervisory support can be arranged.

Who cannot join

  • Moderate/severe learning disability
  • Organic cerebral disease/injury which significantly affects language comprehension or expression
  • Non-English speaking
  • Acute psychosis which would affect engagement
  • Receiving psychological treatment or participating in another research intervention
  • At imminent risk of acting upon thoughts of suicide or of harm to others. This will be screened for by assessing for the presence of active intent or plans to harm themselves or others within the next month. If these individuals consent to be contacted again after a month, the researcher will consider approaching them again to assess for changes to imminent risk. If the individual met the eligibility criteria at this point, the individual would be invited to take part in the study.
  • A history of violence or harm to others to a degree in which clinicians have assessed one-to-one sessions to be unsafe
  • Currently within an inpatient setting or open to a home-based treatment team.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, M25 3BL

Other trials in United Kingdom

About this study

Official title: Exploring the Feasibility and Acceptability of an Autobiographical Memory-Based Intervention for People With Suicidality: A Case Series

The study involves a short therapy intervention for people who are experiencing thoughts of suicide. The intervention will focus upon different memories from the person's life. These memories will vary in the emotions they evoke - some memories will be associated with neutral emotions, whereas others will bring up positive emotions. The intervention will have a particular focus upon memories of times when the participants have moved away from thinking about suicide, with the aim of reinforcing memories of what helped them to reconnect with life. The intervention will also introduce relaxation techniques, in addition to involving a safety planning component. The project aims to consider whether this intervention is acceptable and feasible for this population.

Read the detailed description

This study is looking at whether an autobiographical memory-based intervention is acceptable and suitable for people with thoughts of suicide within a secondary mental health population. Autobiographical memory involves the recollection of past events in a person's own life, and this has been linked to a person's sense of identity, goals, and orientation in the present. Memories linked to negative emotions have been shown to be durable, accessible, and easily and vividly remembered. The power that memories of suicidal ideation and suicide attempts hold is therefore concerning. This intervention aims to support participants to more readily access positive and neutral autobiographical memories, using memory tasks and worksheets. By focusing upon individuals' moves away from suicidal thinking, it also aims to shift the focus onto remembering what led people to reconnect with life.

The study is an experimental case series using a non-concurrent A-B multiple baseline design, in which the participants first attend 3-5 baseline sessions prior to attending 6 intervention sessions. Sessions are one-to-one. The initial baseline session and all intervention sessions will take place face-to-face. The follow-up baseline sessions can be conducted in-person, online via Microsoft Teams, or via telephone, depending on participant preference.

The initial baseline session will involve assessing risk and updating participants' safety plan. The intervention involves 6 sessions of approximately one hour. The first session will focus upon familiarisation to concepts in the intervention, using imagery-based metaphors to support understanding. Sessions 2-4 will focus on different memories - neutral, positive, and memories of moves away from suicidal thinking. Memory tasks will broadly follow the 5 stages outlined in the broad-minded affective coping (BMAC) procedure, but with a focus on these specific memories. In the final 2 sessions, participants will have a choice around which memory to focus on. The final session will also involve post-intervention planning. Outcome measures will be completed in all baseline and intervention sessions.

The study aims to recruit 5-7 participants from community mental health teams (CMHTs) in which supervisory support can be arranged. The intervention will be conducted by the principle investigator (AP), a trainee psychologist, under the supervision of clinical psychologists within the CMHTs (JK and NI) who are also members of the research team.

Being tested
Autobiographical Memory Based Intervention
Keywords
Suicide, Autobiographical Memory
Medical subject headings
Suicidal Ideation, Mental Disorders, Suicide

What participants receive

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

  • Autobiographical Memory Based InterventionOther

    The intervention involves 6 sessions of therapeutic input based around autobiographical memories. Memory based activities will broadly follow the 5 stages outlines in the broad-minded affective coping (BMAC) procedure, but with a focus on specific memories. It will follow the following structure:

    Session 1 - Introduction and Familiarisation Session 2 - Neutral Memories Session 3 - Positive Memories Session 4 - Memories of Moves Away from Suicidality Session 5 - Practice of Preferred Memory (from Sessions 2-4) Session 6 - Continued Practice and Post-Intervention Planning

Study groups in NCT06225531
Study groupRoleWhat they receive
Autobiographical Memory Based InterventionExperimentalAll participants will be placed into the intervention arm, in which the participants will receive 6 autobiographical memory based intervention sessions, lasting approximately one hour. Baseline lengths will vary from 3 - 5 sessions, with the initial session lasting approximately one hour, and follow up sessions lasting approximately 30 minutes. This randomisation is 1) to enable the effects of treatment to be separated from the effects of time seen clinically and 2) in order to control for the therapeutic value of contact.
Receives: Other: Autobiographical Memory Based Intervention

What is being measured

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

  1. Acceptability - Therapeutic Alliance

    This is to consider the therapeutic relationship between the practitioner and participant. Measured using the Working Alliance Inventory - Short Revised, scored out of 60 where a high score indicates strong alliance.

    Measured: Up to 14 weeks

  2. Acceptability - Adverse effects

    This is to assess for any negative outcomes of the intervention. Measured using the Adverse Effects in Psychotherapy questionnaire, with statements scored on a 5 point scale from 'not at all' to 'very much'

    Measured: Up to 14 weeks

  3. Acceptability - Clinical Global Impression

    This is a measure of the practitioner's overall clinical impression of the participant during the session. This is measured using the Clinical Global Impressions Scale, where severity is scored on a scale of 1-7 (where 7 indicates a negative impression/change).

    Measured: Up to 14 weeks

  4. Acceptability - Overall

    The overall acceptability of the intervention will be measured using an adapted Acceptability Scale. This includes measures of multiple key areas which are important for an intervention to be classified as acceptable by a participant. Statements are assessed on a 5 point scale from 'strongly disagree' to 'strongly agree'.

    Measured: Up to 14 weeks

  5. Acceptability - Qualitative Feedback

    Qualitative feedback around the acceptability of the intervention - collected at the end of the Adverse Effects in Psychotherapy Scale with the question 'If you would like to describe your experience of taking part in the study in your own words, please use the following space'.

    Measured: Up to 14 weeks

  6. Feasibility - rates of recruitment, attendance, and completion

    To assess whether the intervention is feasible within this population, the investigators will consider the proportion of participants approached who met the eligibility criteria, and proportion of these who consent to taking part in the study. The investigators will also collect data on attendance rates, where reasonable attendance will be set as ≥ 3 sessions out of the 6-session intervention, in accordance with the criteria set out in a similar case series study. Therapy completion rates will also be recorded, where the investigators will look at the number of participants who completed the final set of therapy measures.

    Measured: Up to 14 weeks

Secondary outcomes (3)
  1. Suicidality

    Measured using the Columbia Suicide Severity Rating Scale. The scale uses yes/no questions, plus an overall score of actual lethality (where 0 is least severe and 5 is most) and of potential severity (where 0 is lowest risk and 2 is highest risk) in relation to the individual's i) most recent suicide attempt, ii) most lethal attempt, and iii) first attempt.

    Measured: Up to 14 weeks

  2. Entrapment

    Entrapment has been closely linked to suicidal ideation and suicide risk. The investigators will measure this using a 4-item Entrapment Scale - Short-Form. This is scored out of 16, where a high score indicates high levels of entrapment.

    Measured: Up to 14 weeks

  3. Perceived Burdensomeness / Thwarted Belonging

    Interpersonal factors have also been linked to suicidal ideation and suicide risk. This will be measured using the Interpersonal Needs Questionnaire. This is scored out of 105, where a high score indicates greater levels of perceived burdensomeness and thwarted belonging.

    Measured: Up to 14 weeks

Timeline

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

  1. First posted26 Jan 2024
  2. Study start15 May 2024
  3. Primary completion21 Aug 2024
  4. Study completion21 Aug 2024

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Experimental case series, with a non-concurrent multiple baseline design. This will involve a baseline period which varies in length between participants (3-5 sessions), followed by an intervention period (6 sessions for all)
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225531
Sponsor's protocol ID
316697
Status last verified
Nov 2024
First submitted
5 Jan 2024
Last updated
12 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gershman SJ. Predicting the Past, Remembering the Future. Curr Opin Behav Sci. 2017 Oct;17:7-13. doi: 10.1016/j.cobeha.2017.05.025. Epub 2017 Jun 9.

    PubMed 28920071
  • Johnson, J., Gooding, P.A., Wood, A.M. et al. A Therapeutic Tool for Boosting Mood: The Broad-Minded Affective Coping Procedure (BMAC). Cogn Ther Res 37, 61-70 (2013). https://doi.org/10.1007/s10608-012-9453-8

  • Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the working alliance inventory. Psychotherapy Research, 16(1), 12-25. https://doi.org/10.1080/10503300500352500

  • Hutton, P. (2016). Positive Clinical Psychology and the Promotion of Happiness, Compassion, and Autonomy in People with Psychosis. In The Wiley Handbook of Positive Clinical Psychology (pp. 245-260). https://doi.org/https://doi.org/10.1002/9781118468197.ch17

  • Gilbert P, Allan S. The role of defeat and entrapment (arrested flight) in depression: an exploration of an evolutionary view. Psychol Med. 1998 May;28(3):585-98. doi: 10.1017/s0033291798006710.

    PubMed 9626715
  • De Beurs D, Cleare S, Wetherall K, Eschle-Byrne S, Ferguson E, B O'Connor D, C O'Connor R. Entrapment and suicide risk: The development of the 4-item Entrapment Scale Short-Form (E-SF). Psychiatry Res. 2020 Feb;284:112765. doi: 10.1016/j.psychres.2020.112765. Epub 2020 Jan 9.

    PubMed 31945600
  • Talmi D, Anderson AK, Riggs L, Caplan JB, Moscovitch M. Immediate memory consequences of the effect of emotion on attention to pictures. Learn Mem. 2008 Mar 5;15(3):172-82. doi: 10.1101/lm.722908. Print 2008 Mar.

    PubMed 18323572
  • Williams JM, Barnhofer T, Crane C, Herman D, Raes F, Watkins E, Dalgleish T. Autobiographical memory specificity and emotional disorder. Psychol Bull. 2007 Jan;133(1):122-48. doi: 10.1037/0033-2909.133.1.122.

    PubMed 17201573
  • Williams SE, Ford JH, Kensinger EA. The power of negative and positive episodic memories. Cogn Affect Behav Neurosci. 2022 Oct;22(5):869-903. doi: 10.3758/s13415-022-01013-z. Epub 2022 Jun 14.

    PubMed 35701665
  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

    PubMed 28126032
  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

    PubMed 20526405
  • Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.

    PubMed 32264985
  • Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19.

    PubMed 21928908
  • Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

    PubMed 22193671

Questions about this trial

What is this clinical trial studying?

A study testing Autobiographical Memory Based Intervention in people with Suicidal Ideation and Mental Health Disorder, run by Lancaster University at 1 site in United Kingdom.

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 4 inclusion and 8 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 12 Nov 2024. 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 Kingdom. 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?

Acceptability - Therapeutic Alliance (time frame: Up to 14 weeks). The study lists 6 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 NCT06225531, 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 12 Nov 2024.

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