DepressionCITADALNCT02186730
Computerised Intervention/Treatment for Adolescent Depression and Low Mood:
A study testing Stressbusters and Websites in people with Depression, run by Leeds and York Partnership NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Stressbusters and Websites
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2014to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12 to 18 years
- Low mood/depression
- co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety
Who cannot join
- Suicidality
- Postnatally depressed
- Suffering psychotic symptoms
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Limetrees Child Adolescent and Family Unit
York, North Yorkshire, YO30 5RE
About this study
Official title: 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).
Read more
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
- Being tested
- Stressbusters, Websites
- Keywords
- Computerised Cognitive Behaviour Therapy, Adolescents, Depression, Low Mood
- Medical subject headings
- Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressbustersBehavioural
cCBT
WebsitesBehavioural
Self help websites
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Websites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up
Measured: 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
Measured: Baseline, 4 months follow up, 12 months follow up
The Short Mood and Feelings Questionnaire
Measured: up to 8 weeks
Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 4 months follow up, 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study start3 Apr 2014
- Primary completion27 Apr 2015
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leeds and York Partnership NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Barry Wright, Principal investigator, LYPFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186730
- Sponsor's protocol ID
- CITADAL
- Acronym
- CITADAL
- Status last verified
- Feb 2020
- First submitted
- 25 Jun 2014
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2
- ClinicalTrials.gov ID
- NCT02186730
- Acronym / sponsor ID
- CITADAL / CITADAL
- Conditions
- Depression
- Keywords
- Computerised Cognitive Behaviour Therapy, Adolescents, Depression, Low Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Leeds and York Partnership NHS Foundation TrustOther government
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 27 Apr 2015 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stressbsuters | Experimental | Behavioral: StressbustersComputerised 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 |
| Websites | Active comparator | Behavioral: WebsitesAny 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12 to 18 years
- Low mood/depression
- co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety
Key exclusion criteria (3 listed)
- Suicidality
- Postnatally depressed
- Suffering psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressbusterscCBT | Behavioural | Stressbsuters |
| WebsitesSelf help websites | Behavioural | Websites |
Primary outcome
Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up
Time frame: baseline, 4 months follow up, 12 months follow up
6 secondary outcomes
Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up
Time frame: Baseline, 4 months follow up, 12 months follow up
The Short Mood and Feelings Questionnaire
Time frame: up to 8 weeks
Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 4 months follow up, 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Wright principal investigator
LYPFT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stressbusters and Websites in people with Depression, run by Leeds and York Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up (time frame: baseline, 4 months follow up, 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.