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

Leeds and York Partnership NHS Foundation Trust

Status: Completed

Conditions: Depression

Treatments: Behavioral: Websites; Behavioral: Stressbusters

Study type: Interventional

Funder types: Other

Identifiers

NCT02186730

CITADAL

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Stressbsuters

Experimental group

Description:

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

Treatment:

Behavioral: Stressbusters

Websites

Active Comparator group

Description:

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.

Treatment:

Behavioral: Websites