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

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ClinicalTrials.gov Identifier: NCT02186730
Recruitment Status : Unknown
Verified September 2016 by Leeds and York Partnership NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Leeds and York Partnership NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Stressbusters Behavioral: Websites Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2
Study Start Date : March 2014
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stressbsuters

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

Behavioral: Stressbusters
cCBT

Active Comparator: Websites
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.
Behavioral: Websites
Self help websites




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. The Short Mood and Feelings Questionnaire [ Time Frame: up to 8 weeks ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 Outcome Measures:
  1. Further mental health support received during trial participation [ Time Frame: 12 months ]
  2. Number of self-harm episodes during trial participation [ Time Frame: 12 months ]
  3. Number of inpatient admissions during trial participation [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186730


Locations
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United Kingdom
Limetrees Child Adolescent and Family Unit
York, North Yorkshire, United Kingdom, YO30 5RE
Sponsors and Collaborators
Leeds and York Partnership NHS Foundation Trust
Investigators
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Principal Investigator: Barry Wright LYPFT

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Responsible Party: Leeds and York Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02186730     History of Changes
Other Study ID Numbers: CITADAL
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Leeds and York Partnership NHS Foundation Trust:
Computerised Cognitive Behaviour Therapy
Adolescents
Depression
Low Mood

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders