- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06225531
An Autobiographical Memory-Based Intervention for Suicidality
Exploring the Feasibility and Acceptability of an Autobiographical Memory-Based Intervention for People With Suicidality: A Case Series
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M25 3BL
- Greater Manchester Mental Health NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Autobiographical Memory Based Intervention
All 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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability - Therapeutic Alliance
Time Frame: Up to 14 weeks
|
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.
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Up to 14 weeks
|
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Acceptability - Adverse effects
Time Frame: Up to 14 weeks
|
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'
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Up to 14 weeks
|
|
Acceptability - Clinical Global Impression
Time Frame: Up to 14 weeks
|
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).
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Up to 14 weeks
|
|
Acceptability - Overall
Time Frame: Up to 14 weeks
|
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'.
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Up to 14 weeks
|
|
Acceptability - Qualitative Feedback
Time Frame: Up to 14 weeks
|
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'.
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Up to 14 weeks
|
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Feasibility - rates of recruitment, attendance, and completion
Time Frame: Up to 14 weeks
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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.
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Up to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidality
Time Frame: Up to 14 weeks
|
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.
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Up to 14 weeks
|
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Entrapment
Time Frame: Up to 14 weeks
|
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.
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Up to 14 weeks
|
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Perceived Burdensomeness / Thwarted Belonging
Time Frame: Up to 14 weeks
|
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.
|
Up to 14 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sessional Mood Scale
Time Frame: Up to 14 weeks
|
Participants' mood from 1-10 will be rated at the start of each session to assess for weekly changes, where 10 indicates the most positive mood.
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Up to 14 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Kelly, ClinPsyD, Lancaster University
Publications and helpful links
General Publications
- 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.
- 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.
- Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 316697
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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