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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06225531
Other study ID # 316697
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2024
Est. completion date August 31, 2024

Study information

Verified date January 2024
Source Lancaster University
Contact Alexandra C Powell, MSc
Phone 07972446384
Email a.powell6@lancaster.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date August 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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: 1. Have you had thoughts or images of ending your life within the past three months? or 2. 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 Design


Intervention

Other:
Autobiographical Memory Based Intervention
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

Locations

Country Name City State
United Kingdom Greater Manchester Mental Health NHS Foundation Trust Manchester

Sponsors (1)

Lead Sponsor Collaborator
Lancaster University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Sessional Mood Scale 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. Up to 14 weeks
Primary 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. Up to 14 weeks
Primary 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' Up to 14 weeks
Primary 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). Up to 14 weeks
Primary 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'. Up to 14 weeks
Primary 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'. Up to 14 weeks
Primary 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. Up to 14 weeks
Secondary 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. Up to 14 weeks
Secondary 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. Up to 14 weeks
Secondary 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. Up to 14 weeks
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