Computerised Intervention/Treatment for Adolescent Depression and Low Mood:

Depression Clinical Trial

— CITADAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186730
• Other study ID #: CITADAL
• Status: Completed
• Phase: N/A
• Start date: April 3, 2014
• Est. completion date: August 1, 2016

Study information

• Verified date: February 2020
• Source: Leeds and York Partnership NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2016
• Est. primary completion date: April 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Stressbusters
cCBT
• Websites
Self help websites

Locations

Country	Name	City	State
United Kingdom	Limetrees Child Adolescent and Family Unit	York	North Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Leeds and York Partnership NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Further mental health support received during trial participation		12 months
Other	Number of self-harm episodes during trial participation		12 months
Other	Number of inpatient admissions during trial participation		12 months
Primary	Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up		baseline, 4 months follow up, 12 months follow up
Secondary	Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up		Baseline, 4 months follow up, 12 months follow up
Secondary	The Short Mood and Feelings Questionnaire		up to 8 weeks
Secondary	Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up		Baseline, 4 months follow up and 12 months follow up
Secondary	Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up		Baseline, 4 months follow up, 12 months follow up
Secondary	Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up		Baseline, 4 months follow up and 12 months follow up
Secondary	The number of health services used by participants between baseline, 4 months and 12 months follow up		Baseline, 4 months follow up, 12 months follow up