Mental Health Intervention for Transdiagnostic Groups in the Community

NCT05491174 | Completed

• 1 other identifier: R&D2022/045
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to evaluate a new protocol-based intervention that is informed by Dialectical Behaviour Therapy (DBT), known as a DBT-informed intervention, delivered in routine mental health settings within South London and Maudsley NHS foundation trust. The intervention is delivered to a group of transdiagnostic service users with a severe mental illness (SMI). It is delivered by a junior workforce who will be referred to as Protocol-Based Intervention Facilitators (P-BIFs). Successful delivery by a less expert workforce has potential to increase routine implementation, compared to delivery by expert staff, where costs of both salary and training are higher. Dialectical Behaviour Therapy (DBT) is a type of psychological treatment recommended for people with a diagnosis of emotionally unstable personality disorder (EUPD). Individuals with a diagnosis of EUPD commonly experience difficulties with managing and responding to their emotions. This is known as emotion dysregulation. Difficulties with emotion dysregulation are thought to play a role in many mental health difficulties. The evidence base for using interventions that are informed by DBT, known of as DBT informed interventions with other mental health diagnoses, is emerging. The current research aims to investigate whether it is possible (feasible) to conduct a randomised control trial evaluating the transdiagnostic DBT-informed skills group for individuals representative of SMI presentations seen within community mental health settings. The study will also examine whether it is possible for junior staff to deliver the manualised group intervention. Service user participants will be randomised to either a 10-week DBT-informed intervention delivered by the P-BIFs, or a waitlist. Those on the waitlist will access the intervention once their involvement in the study has ended. The study will last for up to 1 year. The maximum duration to complete trial participation from consent to completion will be 18 weeks. It is hypothesized that the DBT informed intervention, delivered by junior staff, will be feasible and acceptable with this client population.

Conditions

Severe Mental Illness

Keywords

Severe Mental Illness; Dialectical Behavioural Therapy; Emotion Regulation

Outcome Measures

Primary Outcomes (16)

• Feasibility - Recruitment to the target sample of 30 participants

  Predetermined count data: a. Recruitment to the target sample of 30 participants (15 per arm).

  Within 5 months.

• Feasibility - Retention rates

  Progression criteria for retention rates will be evaluated using a 'traffic light system'. Green: Retention rate of ≥80%. Retention rates are considered feasible to conduct large scale RCT Amber: Retention rate between 41-79%. Explore methods of increasing retention rates before proceeding to large scale RCT Red: Retention rate ≤40%. Retention rates are not considered feasible to conduct large scale RCT

  Through participant pathway, on average 18 weeks.

• Feasibility - Outcome measure completion rates

  Green: Completion of ≥80%. Completion rates of outcome measures are considered feasible to conduct large scale RCT Amber: Completion between 41-79%. Explore methods of increasing outcome measure completion rates before proceeding to large scale RCT. Red: Completion ≤40%. Completion rates of outcome measures are not considered feasible to conduct large scale RCT

  Through participant pathway, on average 18 weeks.

• Feasibility - Adherence to group intervention.

  Completion of the group intervention is operationalised as attending 50% or more of the groups. Green: Intervention completed by ≥80% of participants. Percentage of participants considered to have completed the group is considered feasible to conduct large scale RCT Amber: Intervention completed by between 41-79% of participants. Explore methods of increasing intervention completion rates before proceeding to large scale RCT Red: Intervention completed by ≤40% of participants. Percentage of participants considered to have completed the group not considered feasible to conduct large scale RCT

  Through group intervention, 10 weeks.

• Feasibility - Satisfaction Questionnaire

  'Neutral' ratings and positive ratings of 'agree' and 'strongly agree' will indicate acceptability of the intervention. Satisfaction questionnaire (SQ) adapted for the current research. The brief measure consists of 5 questions that are rated on a 5-point Likert scale, with total score ranging from 5 to 25 where a higher score indicates a higher level of satisfaction. The questionnaire also provides space to enter free text.

  at 18 weeks

• Feasibility - Recruitment to the target sample of between 5 and 10 P-BIFS

  Predetermined count data

  within 5 months.

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 1 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 2 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 3 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 4 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 5 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 6 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 7 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 8 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 9 of DBT-informed intervention

• Feasibility - P-BIF adherence to intervention protocol

  Adherent delivery is defined as meeting ≥90% of checklist. P-BIF attendance at supervision will be recorded as an additional measure of treatment adherence. Green: ≥90% of all sessions rated as adherent. Attending ≥90% of supervision sessions Amber: Between 80- 89% of all sessions rated as adherent. Attending 80-89% of supervision sessions Red: ≤79% of all sessions rated as adherent. Attending ≤79% of supervision sessions

  Week 10 of DBT-informed intervention

Secondary Outcomes (5)

• Change in scores on the Clinical Outcomes of Routine Evaluation -10

  Between week 1 and week 18

• Change in ratings on DIALOG Scale

  Between week 1 and week 18

• Change in scores on Difficulties with Emotional Regulation Scale- 16

  Between week 1 and week 18

• Change in scores on DBT- Ways of Coping Checklist - DBT Skills Subscale

  Between week 1 and week 18

• Change in score on Distress Tolerance Scale

  Between week 1 and week 18

Study Arms (2)

DBT-Informed Intervention

EXPERIMENTAL

The DBT-informed group intervention, known as the 'Managing Emotions Group', will consist of 90-minute sessions, run weekly over 10 weeks.

Behavioral: DBT-Informed skills group

Wait-list control

NO INTERVENTION

Participants will be placed on a wait-list for up to 18 weeks.

Interventions

DBT-Informed skills group BEHAVIORAL

10 session group ran weekly by junior staff (P-BIFs) following a standardised manual-based protocol which can be delivered either face-to-face or via video-call. The groups will be skills-based, covering each of the four modules of DBT: Mindfulness, Distress Tolerance, Emotion Regulation and Interpersonal Effectiveness.

Also known as: Managing Emotions Group

DBT-Informed Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently accessing secondary care mental health services within South London and Maudsley NHS Foundation Trust Services, specifically Lambeth Adult Mental Health services.
• Primary diagnosis considered a severe mental illness according to clinical team.
• Sufficient English language ability to understand group intervention
• Anticipate availability for the duration of the study.
• Capacity to provide informed consent according to clinical team
• Working at South London and Maudsley NHS Foundation Trust with permission granted by their clinical supervisor to participate.
• Hold an undergraduate degree in psychology and/or a minimum of 1-year experience working in mental health settings.
• Capacity to provide informed consent.
• Have completed, or will complete training to deliver the DBT-informed group intervention as part of routine clinical practice.

You may not qualify if:

• Inability to interact in a group setting for 90 minutes
• Not available for study duration
• Difficulties thought to be the result of an organic disorder
• Lack capacity to consent to participation in the study (assessed by clinical team)
• Insufficient English language to understand the group intervention
• a) Inability to commit for the duration of the trial

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either the intervention arm (DBT-informed skills group) or a wait-list control.

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 8, 2022
• Study Start: August 1, 2022
• Primary Completion: January 27, 2023
• Study Completion: July 20, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)