NCT07065071

Brief Summary

The investigators would like to find out if Mentalization-Based Therapy (MBT) is effective for people aged 60+ who struggle in relationships. The study aims to understand whether MBT helps older people to build better relationships and feel better about themselves. There is currently no research with people over 60 and MBT, yet MBT is being offered to the older adult population by NHS trusts throughout the UK without evidence for its effectiveness. As well as developing knowledge about how MBT can help at this point in life, the study aims to improve the quality of care offered. MBT targets mentalization, which is the ability to make sense of one's own and other people's thoughts, feelings, actions and beliefs. Current research suggests that the ability to mentalize changes over the lifespan and may be influenced by many factors, some of which are specific to later life. For example, changes in relationships during later life and biological changes in the brain may impact mentalization systems. The investigators would also like to understand what difficulties MBT may be effective for in later life. The diagnosis of borderline personality disorder (BPD), which MBT was developed to treat, was, until recently, assumed to disappear with age. However, growing evidence suggests that symptoms change, rather than disappear. Given these unknowns, the study will use a Hermeneutic Single-Case Efficacy Design (HSCED). Up to six participants, up to six people who know the participants, and clinicians delivering the MBT interventions will be recruited. Data in the form of questionnaires, self-report and therapy documents will be gathered, and everyone will be interviewed. For each participant, the data will be used to compile both an affirmative (yes, MBT was effective) case, and a sceptic case (no, MBT was not effective). Cases will then be reviewed by an adjudication panel comprising one service user expert by experience, one MBT expert and one expert in another therapeutic modality. For each case, each expert will decide if the affirmative or sceptic case was more likely. Finally, findings will be synthesised and used to draw conclusions about the effectiveness of MBT. The HSCED lends itself to theory-building, as it gathers in-depth data from individuals and facilitates comparison within and between cases. Further, participants' contribution to their own 'rich case record' through change interviews recognises people as taking an active role in their own healing.

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 all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

March 3, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

mentalisationmentalizationlater lifeolder adultsattachment traumaborderline personality disorderattachmentbpdmbtmentalisation-based therapymentalization-based therapy

Outcome Measures

Primary Outcomes (9)

  • Generalized Anxiety Disorder 7-item questionnaire (GAD-7)

    The GAD-7 is a self-report measure of 7 questions pertaining to frequency of symptoms of anxiety experienced over the past 2 weeks. Responses are given on a Likert scale ranging from 0-3, where 0 = 'not at all' and 3 = 'nearly every day', with higher scores indicating greater severity of symptoms of anxiety. Administered to participants.

    Administered at baseline, the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this.

  • Personal Health Questionnaire, 9-item (PHQ-9)

    The PHQ-9 is a self-report measure of 9 questions pertaining to frequency of symptoms of depression experienced over the past 2 weeks. Responses are given on a Likert scale ranging from 0-3, where 0 = 'not at all' and 3 = 'nearly every day', with higher scores indicating greater severity of symptoms of depression. Administered to participants.

    Administered at baseline, the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this.

  • Recovering Quality of Life 10 (ReQoL-10)

    The ReQoL-10 is a self-report measure of 10 questions pertaining to the respondent's frequency of thoughts, feelings and activities relevant to quality of life over the last week. Responses are given on a Likert scale ranging from 0-4, where 0 = 'none of the time' and 4 = 'most or all of the time', with higher scale scores indicating higher quality of life. Administered to participants.

    Administered at baseline, the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this. Also administered weekly at the start of MBT sessions for the duration of the MBT intervention (6 months and 7 weeks).

  • Certainty About Mental States Questionnaire (CAMSQ)

    The CAMSQ is a self-report measure of 20 questions exploring respondent's interpretations of the thoughts, feelings and behaviours of themselves and others. Responses are given on a Likert scale ranging from 0-6, where 0 = 'never' and 6 = 'always'. For scoring, items are divided into two subscales, Certainty about Self and Certainty about Others. High scores on Self-Certainty and middling scores on Other-Certainty are considered to reflect adaptive mentalizing. Administered to participants.

    Administered at baseline, the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this. Also administered weekly at the end of MBT sessions for the duration of the MBT intervention (6 months and 7 weeks).

  • Brief Reflective Functioning Interview (BRFI; adapted)

    The Brief Reflective Functioning Interview (BRFI) is a short semi-standardized interview that is based on the Adult Attachment Interview (AAI), in which participants are asked to reflect on any relationship with someone they have known for a long time. This adapted version is based on Rudden (2010). There are 9 questions, including 'Can you tell me about a specific memory with that person from when you were younger that shows something about your relationship?' and 'Why did you choose to speak about this person?'. Administered to participants. Responses will be coded using the Reflective Functioning Scale to ascertain levels of mentalizing.

    Administered at baseline, the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this.

  • Helpful Aspects of Therapy Questionnaire (HAT)

    The HAT is a qualitative self-report measure of 7 questions exploring helpful and hindering events during therapy sessions. Respondents are asked to briefly write their answers to questions such as 'Of the events which occurred during this session, which one do you feel was the most helpful or important for you personally?', 'Did anything happen during the session that might have been hindering?', 'About where in the session did this event occur?' and 'How long did this event last?'. Respondents are also invited to quantitatively rate the helpfulness of the event using a Likert scale ranging from 1-9, where 1 = 'extremely hindering' and 9 = 'extremely helpful'. Administered to participants and clinicians.

    Administered weekly at the end of MBT sessions for the duration of the MBT intervention (6 months and 7 weeks).

  • Mentalization-Based Therapy (MBT) Adherence & Competence Scale

    The MBT Adherence \& Competence Scale is a self-report measure of 18 items pertaining to fidelity to the MBT model. Ratings are given on a Likert scale ranging from 0-7, where 0 = 'not at all' and 7= 'extensively', where higher scores indicate higher fidelity to MBT. The scale accounts for Frequency, Extensiveness and Quality of interventions, including whether an intervention is absent when it should have been used. Completed by clinicians.

    Administered weekly at the end of MBT sessions for the duration of the MBT intervention (6 months and 7 weeks).

  • Change Interview Schedule

    The Change Interview Schedule is a semi-structured interview schedule exploring change, adapted from Elliot (1996) and Elliot (1999). There are 11 questions including 'What has the MBT group been like for you (so far)?' and 'In general, what do you attribute these various changes to? In other words, what do you think might have brought them about? Both outside and inside of being in the group.' Administered to participants, informants and clinicians.

    Administered at the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this.

  • MBT Documents

    Any documents or paperwork completed or created by participants during MBT will be analysed for change over time and/or themes related to mentalization.

    Administered at the end of the introduction to MBT phase (roughly 7 weeks), and 6 months subsequent to this.

Study Arms (1)

Older adults

People aged 60+ who are eligible for Derbyshire Healthcare NHS Foundation Trust's Later Life MBT group

Other: Mentalization-Based Therapy

Interventions

Group MBT that takes place as part of treatment as usual within Derbyshire Healthcare NHS Foundation Trust's Older Adult Community Mental Health Team's service.

Also known as: MBT, Mentalisation-Based Therapy
Older adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to six participants will be recruited via purposive convenience sampling from people enrolled on one of Derbyshire Healthcare Foundation Trust's (DHCFT's) Later Life MBT interventions. The MBT group interventions take place in a secondary care outpatient setting. Once participants have been recruited, they will be asked to invite someone with whom they have a close relationship to participate in the study, known as the informant. Up to six informants will be recruited in this way via purposive convenience sampling. Up to four clinicians running the Later Life MBT intervention will be recruited via purposive convenience sampling, since they will be the people already running the group.

You may qualify if:

  • Participants - people who:
  • Have been referred into and assessed as suitable for a Derbyshire Healthcare NHS Foundation Trust's Later Life MBT Group
  • Have persistent (i.e. 1 year+) and pervasive (i.e. multiple relationships) difficulties in relationships and so stand to benefit from the intervention
  • Those aged 60+
  • Have the ability to complete measures
  • Can communicate comfortably in spoken and written English
  • Informants - people who:
  • Are identified by the participant
  • Are aged 18+
  • The participant considers themselves to have a close relationship with
  • Have the ability to complete appropriate measures
  • Can communicate comfortably in spoken and written English
  • Clinicians - people who:
  • Are involved in delivering/facilitating the MBT interventions with participants

You may not qualify if:

  • Participants - people who:
  • Are undertaking any other psychological intervention
  • Do not have the capacity to give informed consent; since capacity is dynamic, this will be assessed by clinicians and the independent outcome assessor on an ongoing basis according to their clinical judgement. If lack of capacity is identified during an interview, clinical judgement would be used around rescheduling and the information would be fed back to the individual's clinical team or escalated as necessary
  • Informants - people who:
  • Do not have the capacity to give informed consent; since capacity is dynamic, this will be assessed by the independent outcome assessor according to their clinical judgement. If lack of capacity was identified during an interview, clinical judgement would be used around rescheduling and the information would be escalated as necessary
  • Clinicians - people who:
  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derbyshire Healthcare NHS Foundation Trust

Derby, Derbyshire, DE22 3LZ, United Kingdom

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thomas Schröder, PhD

    University of Nottingham

    STUDY DIRECTOR
  • Heather Cogger-Ward, DClinPsy

    University of Nottingham

    PRINCIPAL INVESTIGATOR
  • Helen Philpott, DClinPsy

    Derbyshire Healthcare NHS Foundation Trust

    STUDY DIRECTOR
  • Laura Hayward, DClinPsy

    Derbyshire Healthcare NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

July 15, 2025

Study Start

April 1, 2025

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Locations