Adolescent depression Mental and Behavioural Disorders
Conditions
Interventions
This study is a multi-school, assessor-blind, parallel-group, randomized, controlled trial in adolescents in England comparing two psychological interventions. Both interventions consist of individual
NDS) are assigned with a 1:1 allocation ratio. Following the baseline visit, eligible participants will be randomised using an online Kings Clinical Trials Unit (KCTU) randomisation system.
IMAGINE:
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
16 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16-18 2. Able to provide Informed consent 3. Willing and able to engage in psychological therapy and complete assessments 4. Scoring above the clinical cut-off on the Mood and Feelings Questionnaire at both screen and baseline assessment (MFQ of 29 items at the screen, clinical cut-off =17; MFQ of 33 items at baseline, clinical cut-off =20)
Exclusion criteria
Exclusion criteria: 1. Diagnosis of learning disability or significant head injury, neurological disorder or epilepsy 2. Unable to fluently communicate in spoken English 3. Currently receiving another psychological intervention (including school counselling) 4. Moderate to high levels of risk. This will be verbally assessed by the participant at the first interview and discussed under supervision with the Chief Investigator (VP). This will be based on clinical judgement, but an outline is that Imagery Rescripting is unlikely to be appropriate for young people presenting with current and/or significant self-harm (e.g., which requires medical attention); active suicidal ideation and an active plan to harm themselves and; those presenting with significant risk to others. The clinical decision will be informed by their history of risk. 5. Current diagnosis of bipolar disorder, PTSD or psychosis. This will be stated in the information sheet and verbally assessed by the participant at the first interview 6. Other significant conditions or factors that contraindicate the individual's participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured using the Mood and Feelings Questionnaire (MFQ). The primary endpoint is 8 weeks following randomization. The MFQ will be collected at four-time points: pre-randomisation/baseline, 8, 16 and 24 weeks after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes measures of therapeutic mechanisms: All measures will be collected at four time points: pre-randomisation/baseline, 8, 16 and 24 weeks after randomisation. 1. Anxiety measured using the anxiety subscales on the Revised Children’s Anxiety and Depression scale (RCADS) 2. Self-worth measured using the Harter Self-Perception Scale Self-worth subscale (SPPC) 3. Sleep difficulties measured using the Insomnia Severity Index (ISI) 4. School and social impairment, activity levels and rumination measured using the Behavioural Activation for Depression Scale (BADS) 5. Mental Imagery measured using the Assessing Mental Imagery in Youth (AMI-Y) Questionnaire 6. Distress/post-traumatic stress symptoms to a negative event measured using Child Revised Impact of Event Scale (CRIES) 7. Future imagery vividness measured using Prospective Imagery Task (PIT) 8. Memory specificity measured using Autobiographical Memory Task (AMT) 9. Self-Compassion measured using the Self-Compassion Scale- Short Form (SCS) Acceptability, Safety and Adherence, Fidelity and Contamination: 1. Recruitment and retention will be recorded in a CONSORT diagram. The number of participants who drop out at each stage of the trial and the reasons for this will be recorded. 2. Acceptability will be measured using a feedback questionnaire (including quantitative and written responses). The feedback questionnaire will also ask questions probing peer-to-peer contamination, the therapeutic relationship and therapist motivation. 3. Risk to self and to/from others (e.g., self-harm; suicidal ideation) is measured in a semi-structured clinical interview at each assessment and monitored throughout. This semi-structured interview will also assess clinical history (e.g. diagnoses, medication). All adverse events will be recorded and reported. 4. The range and average number of sessions completed, total contact time and homework adherence will indicate participant compliance. 5. Adherence and competenc | — |
Countries
England, United Kingdom
Outcome results
None listed