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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Stressbusters; Behavioral: Websites

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO30 5RE
      • Limetrees Child Adolescent and Family Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
The Short Mood and Feelings Questionnaire	up to 8 weeks
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
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
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
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

Other Outcome Measures

Outcome Measure	Time Frame
Further mental health support received during trial participation	12 months
Number of self-harm episodes during trial participation	12 months
Number of inpatient admissions during trial participation	12 months

Collaborators and Investigators

• Sponsor: Leeds and York Partnership NHS Foundation Trust
• Investigators: Principal Investigator: Barry Wright, LYPFT

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2014
• Primary Completion (Actual): April 27, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; Depression; Computerised Cognitive Behaviour Therapy; Low Mood
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: CITADAL