NCT04291547

Brief Summary

The primary aim of this non-randomised feasibility study is to 1) examine the acceptability of a newly developed computerised Behavioural Activation programme (BALM) in treating young people experiencing low mood/depression and 2) assess the feasibility of undertaking a pilot Randomised Controlled Trial (RCT) of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

February 25, 2020

Last Update Submit

April 9, 2021

Conditions

Low MoodDepression

Keywords

Young people

Outcome Measures

Primary Outcomes (6)

  • Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates

    Assessed by examining questionnaire response rates

    4 months

  • Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented

    Assessed by examining the percentage of those eligible who consented to the study

    4 months

  • Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal

    Assessed by examining number and reasons for withdrawal

    4 months

  • Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance

    Assessed by examining session attendance

    4 months

  • To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence

    Assessed by examining session adherence

    4 months

  • To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire

    Assessed by examining responses on an evaluation questionnaire comprising 15 short questions

    4 months

Study Arms (1)

Computerised Behavioural Activation Programme

EXPERIMENTAL

All recruited young people will be given the BALM (Behavioural Activation for Low Mood) programme to work through

Device: BALM

Interventions

BALMDEVICE

An online Behavioural Activation programme for young people with mild to moderate low mood/depression. The programme comprises 10 treatment sessions lasting 30 to 45 minutes

Computerised Behavioural Activation Programme

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 11 to 16 years at the date of consent
  • Experiencing low mood or depression symptoms as defined by a score of ≥20 on the Mood and Feelings Questionnaire
  • In agreement that their primary care provider and a parent/guardian can be informed of any concerns the lead researcher has about their wellbeing during participation

You may not qualify if:

  • Within the normal range on the measure of depressive symptoms (i.e. attaining a score of ≤19 on the Mood and Feelings Questionnaire)
  • Experiencing severe low mood or depression symptoms
  • Having a comorbid mental health diagnosis of Bipolar Disorder or Psychosis.
  • Non-English speaking (due to the small scope of this study, the option of providing translated versions of BALM and the outcome measures was not feasible)
  • Deemed to be actively at risk of self harm or suicide
  • Have no access to the internet and therefore no programme access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tees Esk and Wear Valleys NHS Foundation Trust

York, United Kingdom

Location

MeSH Terms

Conditions

Consciousness DisordersDepression

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Barry Wright

    University of York

    STUDY CHAIR

  • Dean McMillan

    University of York

    STUDY CHAIR

  • Antonina Mikocka-Walus

    Deakin University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 2, 2020

Study Start

June 10, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)