Clinical trial NCT02186730: Computerised Intervention/Treatment for Adolescent Depression and Low Mood:
Official title: Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Computerised Cognitive Behaviour Therapy
Adolescents
Depression
Low Mood
Lead sponsor: Leeds and York Partnership NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2014-07-10
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up
timeFrame: baseline, 4 months follow up, 12 months follow up
Secondary outcomes:
measure: Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: The Short Mood and Feelings Questionnaire
timeFrame: up to 8 weeks
measure: Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
timeFrame: Baseline, 4 months follow up and 12 months follow up
measure: Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up
timeFrame: Baseline, 4 months follow up and 12 months follow up
measure: The number of health services used by participants between baseline, 4 months and 12 months follow up
timeFrame: Baseline, 4 months follow up, 12 months follow up
Other outcomes:
measure: Further mental health support received during trial participation
timeFrame: 12 months
measure: Number of self-harm episodes during trial participation
timeFrame: 12 months
measure: Number of inpatient admissions during trial participation
timeFrame: 12 months
Locations:
city: York
country: United Kingdom
facility: Limetrees Child Adolescent and Family Unit
state: North Yorkshire
Study officials:
affiliation: LYPFT
name: Barry Wright
role: PRINCIPAL_INVESTIGATOR
References: