Computerised Intervention/Treatment for Adolescent Depression and Low Mood:

NCT02186730 | Completed DMC

• 1 other identifier: CITADAL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Computerised Cognitive Behaviour Therapy; Adolescents; Depression; Low Mood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

Stressbsuters

EXPERIMENTAL

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

Websites

ACTIVE COMPARATOR

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

Interventions

Stressbusters BEHAVIORAL

cCBT

Stressbsuters

Websites BEHAVIORAL

Self help websites

Websites

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Suicidality
• Postnatally depressed
• Suffering psychotic symptoms

Sponsors & Collaborators

• Leeds and York Partnership NHS Foundation Trust: lead

Study Sites (1)

Limetrees Child Adolescent and Family Unit

York, North Yorkshire, YO30 5RE, United Kingdom

Location

MeSH Terms

Conditions

Depression; Consciousness Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Barry Wright

  LYPFT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: July 10, 2014
• Study Start: April 3, 2014
• Primary Completion: April 27, 2015
• Study Completion: August 1, 2016
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

GB (1)