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Completed

NCT Number: NCT02186730

Computerised Intervention/Treatment for Adolescent Depression and Low Mood:

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limetrees Child Adolescent and Family Unit

York, North Yorkshire, YO30 5RE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stressbusters

Behavioral

cCBT

Websites

Behavioral

Self help websites

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Leeds and York Partnership NHS Foundation Trust

Other Gov

Registry information

Official study title

Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2

Acronym: CITADAL

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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