NCT06225531

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

January 5, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

SuicideAutobiographical Memory

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Suicidality

    Up to 14 weeks

  • Entrapment

    Up to 14 weeks

  • Perceived Burdensomeness / Thwarted Belonging

    Up to 14 weeks

Other Outcomes (1)

  • Sessional Mood Scale

    Up to 14 weeks

Study Arms (1)

Autobiographical Memory Based Intervention

EXPERIMENTAL

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.

Other: Autobiographical Memory Based Intervention

Interventions

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

Autobiographical Memory Based Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Manchester Mental Health NHS Foundation Trust

Manchester, M25 3BL, United Kingdom

Location

Related Publications (14)

  • 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.

    PMID: 28920071BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 9626715BACKGROUND
  • 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.

    PMID: 31945600BACKGROUND
  • 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.

    PMID: 18323572BACKGROUND
  • 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.

    PMID: 17201573BACKGROUND
  • 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.

    PMID: 35701665BACKGROUND
  • 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.

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

    PMID: 20526405BACKGROUND
  • 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.

    PMID: 32264985BACKGROUND
  • 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.

    PMID: 21928908BACKGROUND
  • 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.

    PMID: 22193671BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationMental DisordersSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • James Kelly, ClinPsyD

    Lancaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 26, 2024

Study Start

May 15, 2024

Primary Completion

August 21, 2024

Study Completion

August 21, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations