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Clinical Trials/NCT03524196
NCT03524196CompletedNot Applicable

Understanding What is Helpful and Unhelpful in Intervention With Online Relational Agent MYLO: An Intervention Process Study.

University of Manchester1 site in 1 country17 target enrollmentStarted: November 19, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
MOL helpfulness ratings questionnaire.

Study Overview

Brief Summary

Mental health problems such as anxiety and depression are common. Services are finding it difficult to treat people quickly. This has led to computers being used to treat common problems.

Research has shown that around half of people who have mental health problems have more than one difficulty (e.g.low mood and worry). Many of the computer interventions available are not designed to work with more than one problem at a time. This can make them less helpful and can lead to people stopping intervention early.

A talking intervention called the Method of Levels is suitable for people with more than one problem. A new computer programme that aims to emulate this type of intervention is called Manage Your Life Online (MYLO). MYLO is accessed online. Users have conversations with MYLO by typing on a computer keyboard. MYLO aims to help people to talk freely and experience feelings related to a problem. In this way, people can find new ways of thinking about their problem. MYLO can be used as often as the person wants.

MYLO has been tested twice before with student volunteers. Participants said that it was helpful in solving an everyday problem. The investigators are not aware of any research that has tested a programme like MYLO for people experiencing mental health problems.

24 adult service users will be recruited from Self Help Services, a participating organisation in Manchester contracted to provide primary care mental health provision for NHS patients. Participants will use MYLO for a two week period.

The investigators aim to conduct a detailed examination of what questions service users find helpful and unhelpful in intervention with MYLO and whether service user perceptions are related to key mechanisms of psychological change identified in MOL. The information gathered from this study will help to increase understanding of how this type of intervention works and what makes it most helpful to service users. These findings will inform improvements to the MYLO programme to improve its acceptability to service users.

Detailed Description

BACKGROUND

Mental health problems such as anxiety and depression are prevalent and related to significant personal and economic burden. Discrepancy between supply and demand of effective psychological therapies has led to the proliferation of computerised therapies for psychological intervention. Computerised cognitive behaviour therapy (cCBT) packages such as 'Fearfighter' and 'Beating the Blues' are recommended by NICE for the treatment of depression and phobias. However, studies have demonstrated high levels of attrition and although active telephone support seems to facilitate their effectiveness this has led to concerns about their efficiency and cost effectiveness.

Most available cCBT interventions are disorder specific and may not provide a good fit for the estimated 50% of service users who experience comorbidities. Transdiagnostic psychological interventions delivered in traditional and computerised formats have been shown to provide equivalent effects to disorder specific interventions of their type and have the potential to improve acceptability and efficiency.

A transdiagnostic form of cognitive therapy called the Method of Levels (MOL) has been used in the treatment of a wide range of psychological problems and is suitable for service users experiencing more than one problem and problems that do not fit into pre-defined diagnostic categories. MOL is differentiated from other cognitive therapies as it originates from a unifying theoretical approach known as Perceptual Control Theory (PCT). PCT posits that psychological distress is due to sustained conflict in internal control systems that are essential to all living things. Therefore, the aim of MOL is to increase a client's sense of control through enabling them to talk freely whilst supporting experiences of emotional distress necessary to increase awareness of internal conflict.

The acceptability of computerised interventions to service users is paramount if increased uptake, adherence and 'reach' are to be achieved whilst improving efficiency. Computerised intervention that offers greater collaboration has the potential to increase its acceptability. The investigators propose that one way of achieving greater collaboration in computerised interventions is through relational agents. Relational agents are computer programmes that simulate conversation. A relational online agent called MYLO (Manage Your Life Online) has been developed at the University of Manchester and uses artificial intelligence to simulate a MOL style conversation with a user via typed text. MYLO has been evaluated in two feasibility trials using student samples and has shown promising results.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Able to converse, read and write in English proficiently
  • Service user considers the MYLO programme to offer a potentially helpful format of intervention
  • Service user has access to a device connected to the internet

Exclusion Criteria

  • A higher intensity (step 3) psychological intervention has been recommended
  • Service user has current suicidal intent or persistent self-injury
  • Service user is currently psychotic
  • Service user has current substance dependence identified as a primary problem
  • There is a known neurological or organic basis for their presentation (e.g. dementia)
  • Service user has a moderate to severe learning disability which would impair their ability to use the computer programme and take part
  • Service user has a sight difficulty which would impair their ability to use the computer programme and take part

Arms & Interventions

MYLO

Experimental

Manage Your Life Online (MYLO) is accessed online using a username and password. Client's type into the MYLO conversation box about a problem they are currently experiencing. MYLO operates by analysing the client's input of text for key terms and themes. It responds with questions about the problem aimed at encouraging higher level awareness.

Participants will decide how often to use the MYLO programme over a two week period. This is likely to be a reasonable length of time to allow at least one use of the programme with no upper limit on usage.

Intervention: Manage Your Life Online (MYLO) (Other)

Outcomes

Primary Outcomes

MOL helpfulness ratings questionnaire.

Time Frame: 2 weeks post baseline

Participants will read their first MYLO conversation transcript and be asked to choose two questions which they found helpful and two questions which they found unhelpful. Participants will be interviewed about why they have chosen each of the four questions and this will be audio taped. Participants will complete a MOL helpfulness rating scale for each of the 4 questions. Ratings of helpfulness are on an 11-point likert scale (0, not helpful at all to 10, extremely helpful) and ratings of the degree to which the question enabled 1) a sense of control over what is happening 2) the ability to talk freely 3) the ability to experience emotion and 4) to see the problem in a new way.

Secondary Outcomes

  • Duration of MYLO use(2 weeks post baseline)
  • Patient Health Questionnaire (PHQ-9)(Baseline & two weeks post)
  • Qualitative feedback about the MYLO interface(2 weeks post baseline)
  • Frequency of MYLO use(2 weeks post baseline)
  • Generalised Anxiety Disorder Questionnaire (GAD-7)(Baseline & two weeks post)
  • Psychological Outcome Profiles questionnaire (PSYCHLOPS)(Baseline & two weeks post)
  • Reorganisation of Conflict Scale (RoC)(Baseline & two weeks post)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hannah Gaffney

Trainee Clinical Psychologist

University of Manchester

Study Sites (1)

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