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Computerised Intervention/Treatment for Adolescent Depression and Low Mood: (CITADAL)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Stressbusters
Websites
Sponsored by
Leeds and York Partnership NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Computerised Cognitive Behaviour Therapy, Adolescents, Depression, Low Mood

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 12 to 18 years
  • Low mood/depression
  • co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety

Exclusion Criteria:

  • Suicidality
  • Postnatally depressed
  • Suffering psychotic symptoms

Sites / Locations

  • Limetrees Child Adolescent and Family Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stressbsuters

Websites

Arm Description

Computerised Cognitive Behaviour package consisting of eight 30-45 minute sessions of CBT designed for 12-18 year olds. Each Stressbusters session is an interactive presentation featuring narration synchronised with videos, animations, graphics and printouts. The programme has a narrator guiding individuals through each of the eight sessions in a linear progression. Each session builds on the knowledge gained in previous sessions and on tasks carried out at home. Sessions contain flexible "add-ons" such as written fact sheets (for example about bullying, sleep problems) which can be printed out and taken away together with home practice related handouts from the programme (for example mood diary sheets). Session topics include getting activated, relapse prevention, challenging negative thoughts and problem solving

Any individuals randomised to arm 2 of the trial will spend the equivalent time accessing currently available self help websites that provide information about low mood/depression. These four websites will be the same as those used in our initial feasibility study of which, based on our preliminary data, there is evidence for their usefulness.

Outcomes

Primary Outcome Measures

Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up

Secondary Outcome Measures

Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up
The Short Mood and Feelings Questionnaire
Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up
Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up
The number of health services used by participants between baseline, 4 months and 12 months follow up

Full Information

First Posted
June 25, 2014
Last Updated
February 19, 2020
Sponsor
Leeds and York Partnership NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02186730
Brief Title
Computerised Intervention/Treatment for Adolescent Depression and Low Mood:
Acronym
CITADAL
Official Title
Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2014 (Actual)
Primary Completion Date
April 27, 2015 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leeds and York Partnership NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study forms the second phase of previous work to examine the effectiveness of computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low mood/depression. Depression affects around 2% of adolescents. Antidepressants are not recommended for this age range as a first line treatment because of concerns about their usefulness and side effects. Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is effective and one of the main treatments recommended for depression. It has been suggested that computerised versions of CBT (cCBT) may be effective for treating depression in young people who may prefer this to seeing a therapist face-to-face, but little research exists to date to support this. This study examines the feasibility of running a large scale randomised controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help websites for adolescents with low mood and depression (LMD). Eligible and consenting participants will complete several questionnaires to assess their mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to selected websites providing self help for LMD. Participants will complete further mood questionnaires 4 and 12 months after treatment completion/withdrawal. We have already recruited 97 individuals to this trial but aim to recruit a further 48 participants to collect further information. We are also keen to find out whether sending participants text messages before sessions and around follow up periods will increase attendance/completion. Therefore all trial participants will receive text messages from the research team during their participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Computerised Cognitive Behaviour Therapy, Adolescents, Depression, Low Mood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stressbsuters
Arm Type
Experimental
Arm Description
Computerised Cognitive Behaviour package consisting of eight 30-45 minute sessions of CBT designed for 12-18 year olds. Each Stressbusters session is an interactive presentation featuring narration synchronised with videos, animations, graphics and printouts. The programme has a narrator guiding individuals through each of the eight sessions in a linear progression. Each session builds on the knowledge gained in previous sessions and on tasks carried out at home. Sessions contain flexible "add-ons" such as written fact sheets (for example about bullying, sleep problems) which can be printed out and taken away together with home practice related handouts from the programme (for example mood diary sheets). Session topics include getting activated, relapse prevention, challenging negative thoughts and problem solving
Arm Title
Websites
Arm Type
Active Comparator
Arm Description
Any individuals randomised to arm 2 of the trial will spend the equivalent time accessing currently available self help websites that provide information about low mood/depression. These four websites will be the same as those used in our initial feasibility study of which, based on our preliminary data, there is evidence for their usefulness.
Intervention Type
Behavioral
Intervention Name(s)
Stressbusters
Intervention Description
cCBT
Intervention Type
Behavioral
Intervention Name(s)
Websites
Intervention Description
Self help websites
Primary Outcome Measure Information:
Title
Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up
Time Frame
baseline, 4 months follow up, 12 months follow up
Secondary Outcome Measure Information:
Title
Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
The Short Mood and Feelings Questionnaire
Time Frame
up to 8 weeks
Title
Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
Time Frame
Baseline, 4 months follow up and 12 months follow up
Title
Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up
Time Frame
Baseline, 4 months follow up and 12 months follow up
Title
The number of health services used by participants between baseline, 4 months and 12 months follow up
Time Frame
Baseline, 4 months follow up, 12 months follow up
Other Pre-specified Outcome Measures:
Title
Further mental health support received during trial participation
Time Frame
12 months
Title
Number of self-harm episodes during trial participation
Time Frame
12 months
Title
Number of inpatient admissions during trial participation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12 to 18 years Low mood/depression co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety Exclusion Criteria: Suicidality Postnatally depressed Suffering psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Wright
Organizational Affiliation
LYPFT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limetrees Child Adolescent and Family Unit
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO30 5RE
Country
United Kingdom

12. IPD Sharing Statement

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Computerised Intervention/Treatment for Adolescent Depression and Low Mood:

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