Feasibility and Acceptability of a Randomised Controlled Trial, Examining a Transdiagnostic DBT-informed Skills Group Intervention Delivered by Protocolised Based Intervention Facilitators (P-BIFS) for Adults in Community Mental Health Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King's College London
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Feasibility - Adherence to group intervention.
Study Overview
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.
Detailed Description
Primary objectives of the research are:
- To determine the feasibility and acceptability of conducting a double-arm randomised control trial (RCT) of a transdiagnostic Dialectical Behavioural Therapy informed (DBT-informed) group intervention within secondary care mental health settings.
- To determine feasibility and acceptability of training Protocol Based Intervention facilitators (P-BIFs), to deliver the intervention as per the protocol.
Feasibility will be measured using pre-specified criteria.
A secondary objective is to explore change in assessment scores between the treatment and control group.
The research will utilise an experimental, open-label double-arm randomised design investigating feasibility. Service user participants will be randomly allocated to either the intervention group or the waitlist control group using randomisation software. Pairwise randomisation will be used whereby participants will be randomised in pairs for an approximately equal number of participants in each arm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for service users:
- •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
- •Inclusion Criteria for P-BIFs:
- •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.
Exclusion Criteria
- •for service users:
- •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
- •Exclusion Criteria for P-BIFs:
- •a) Inability to commit for the duration of the trial
Arms & Interventions
DBT-Informed Intervention
The DBT-informed group intervention, known as the 'Managing Emotions Group', will consist of 90-minute sessions, run weekly over 10 weeks.
Intervention: DBT-Informed skills group (Behavioral)
Wait-list control
Participants will be placed on a wait-list for up to 18 weeks.
Outcomes
Primary Outcomes
Feasibility - Adherence to group intervention.
Time Frame: Through group intervention, 10 weeks.
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
Feasibility - Satisfaction Questionnaire
Time Frame: at 18 weeks
'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.
Feasibility - Recruitment to the target sample of 30 participants
Time Frame: Within 5 months.
Predetermined count data: a. Recruitment to the target sample of 30 participants (15 per arm).
Feasibility - Recruitment to the target sample of between 5 and 10 P-BIFS
Time Frame: within 5 months.
Predetermined count data
Feasibility - Retention rates
Time Frame: Through participant pathway, on average 18 weeks.
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
Feasibility - Outcome measure completion rates
Time Frame: Through participant pathway, on average 18 weeks.
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 10 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 1 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 2 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 3 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 4 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 5 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 6 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 7 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 8 of DBT-informed intervention
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
Feasibility - P-BIF adherence to intervention protocol
Time Frame: Week 9 of DBT-informed intervention
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
Secondary Outcomes
- Change in scores on the Clinical Outcomes of Routine Evaluation -10(Between week 1 and week 18)
- Change in score on Distress Tolerance Scale(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)