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Mental Health Intervention for Transdiagnostic Groups in the Community

NCT05491174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

DBT-Informed skills group

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-01-27
Completion
2023-07-20

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491174 on ClinicalTrials.gov