NCT03524196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

April 20, 2018

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • MOL helpfulness ratings questionnaire.

    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.

    2 weeks post baseline

Secondary Outcomes (7)

  • Reorganisation of Conflict Scale (RoC)

    Baseline & two weeks post

  • Patient Health Questionnaire (PHQ-9)

    Baseline & two weeks post

  • Generalised Anxiety Disorder Questionnaire (GAD-7)

    Baseline & two weeks post

  • Psychological Outcome Profiles questionnaire (PSYCHLOPS)

    Baseline & two weeks post

  • Qualitative feedback about the MYLO interface

    2 weeks post baseline

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: Manage Your Life Online (MYLO)

Interventions

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.

MYLO

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 16+
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, United Kingdom

Location

Related Publications (14)

  • Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.

    PMID: 28768327BACKGROUND
  • Bennion MR, Hardy G, Moore RK, Millings A. E-therapies in England for stress, anxiety or depression: what is being used in the NHS? A survey of mental health services. BMJ Open. 2017 Jan 23;7(1):e014844. doi: 10.1136/bmjopen-2016-014844.

    PMID: 28115336BACKGROUND
  • Bohannon J. Artificial intelligence. The synthetic therapist. Science. 2015 Jul 17;349(6245):250-1. doi: 10.1126/science.349.6245.250. No abstract available.

    PMID: 26185240BACKGROUND
  • Carey, T. (2006). The method of levels : how to do psychotherapy without getting in the way. Living Control Systems Pub.

    BACKGROUND
  • Carey, T. a., & Mullan, R. J. (2008). Evaluating the method of levels. Counselling Psychology Quarterly, 21(October 2014), 247-256. https://doi.org/10.1080/09515070802396012

    BACKGROUND
  • Cocklin AA, Mansell W, Emsley R, McEvoy P, Preston C, Comiskey J, Tai S. Client Perceptions of Helpfulness in Therapy: a Novel Video-Rating Methodology for Examining Process Variables at Brief Intervals During a Single Session. Behav Cogn Psychother. 2017 Nov;45(6):647-660. doi: 10.1017/S1352465817000273. Epub 2017 May 22.

    PMID: 28528592BACKGROUND
  • Duarte A, Walker S, Littlewood E, Brabyn S, Hewitt C, Gilbody S, Palmer S. Cost-effectiveness of computerized cognitive-behavioural therapy for the treatment of depression in primary care: findings from the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial. Psychol Med. 2017 Jul;47(10):1825-1835. doi: 10.1017/S0033291717000289. Epub 2017 Feb 23.

    PMID: 28228182BACKGROUND
  • Gaffney H, Mansell W, Edwards R, Wright J. Manage Your Life Online (MYLO): a pilot trial of a conversational computer-based intervention for problem solving in a student sample. Behav Cogn Psychother. 2014 Nov;42(6):731-46. doi: 10.1017/S135246581300060X. Epub 2013 Jul 30.

    PMID: 23899405BACKGROUND
  • Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G; REEACT collaborative. Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362-367. doi: 10.1192/bjp.bp.116.192435. Epub 2017 Mar 2.

    PMID: 28254959BACKGROUND
  • Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.

    PMID: 19378696BACKGROUND
  • Knowles SE, Toms G, Sanders C, Bee P, Lovell K, Rennick-Egglestone S, Coyle D, Kennedy CM, Littlewood E, Kessler D, Gilbody S, Bower P. Qualitative meta-synthesis of user experience of computerised therapy for depression and anxiety. PLoS One. 2014 Jan 17;9(1):e84323. doi: 10.1371/journal.pone.0084323. eCollection 2014.

    PMID: 24465404BACKGROUND
  • Lamers F, van Oppen P, Comijs HC, Smit JH, Spinhoven P, van Balkom AJ, Nolen WA, Zitman FG, Beekman AT, Penninx BW. Comorbidity patterns of anxiety and depressive disorders in a large cohort study: the Netherlands Study of Depression and Anxiety (NESDA). J Clin Psychiatry. 2011 Mar;72(3):341-8. doi: 10.4088/JCP.10m06176blu. Epub 2011 Jan 25.

    PMID: 21294994BACKGROUND
  • Newby JM, Mewton L, Andrews G. Transdiagnostic versus disorder-specific internet-delivered cognitive behaviour therapy for anxiety and depression in primary care. J Anxiety Disord. 2017 Mar;46:25-34. doi: 10.1016/j.janxdis.2016.06.002. Epub 2016 Jun 23.

    PMID: 27396841BACKGROUND
  • Powers, W. (1973). Behavior: The control of perception. Chicago: Aldine publishing co. Retrieved from http://doi.wiley.com/10.1002/bs.3830190609

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 14, 2018

Study Start

November 19, 2018

Primary Completion

May 1, 2019

Study Completion

July 11, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations