Condition category
Mental and Behavioural Disorders
Date applied
03/04/2017
Date assigned
04/04/2017
Last edited
04/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Depression is one of the most common mental health conditions worldwide. The symptoms of depression can vary greatly from person to person, but generally include low mood, problems with sleeping and/or eating, and loss of interest in life. If a person experiences depression during adolescence, it can impact the rest of their life. Adolescent depression is often associated with mental health and social difficulties that often continue into adulthood, including higher social dysfunction, poorer academic performance, more physical ill health complaints and more completed suicides. The aim of this study is to assess the possibility of running a trial of a brief talking therapy in schools for adolescents with symptoms of depression. The study will take place in several secondary schools and sixth form colleges in the UK.

Who can participate?
Adolescents aged 16-18 who are showing signs of depression.

What does the study involve?
Participants are randomly allocated to one of two groups, who each receive a different type of talking therapy. Those in the first group receive an ‘imagery-based cognitive behavioural intervention’ and those in the second group receive ‘non-directive supportive therapy’. Both therapies involve three to four face to face sessions, lasting for up to 90 minutes. Participants in both groups are asked to complete three assessments: one before therapy, one after therapy and one three months later. Each assessment takes around an hour to complete.

What are the possible benefits and risks of participating?
Both talking therapies are likely to have some benefit as both aim to reduce low mood and improve self-esteem. There are no known risks of taking part in the study.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
April 2015 to May 2019

Who is funding the study?
1. Health Education England (UK)
2. National Institute for Health Research (UK)

Who is the main contact?
Dr Victoria Pile (public)
victoria.pile@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Victoria Pile

ORCID ID

http://orcid.org/0000-0002-9177-2844

Contact details

Department of Psychology
Institute of Psychiatry
Psychology and Neuroscience
Kings College London
Denmark Hill
London
SE5 8AF
United Kingdom
+44 20 7848 0389
victoria.pile@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A brief early intervention for adolescent depression that targets emotional memories: a feasibility randomised controlled trial

Acronym

IMAGINE

Study hypothesis

The aim of this study is to establish the practicality and acceptability of implementing a new early intervention for adolescent depression that targets emotional memories, within a school setting.

Ethics approval

Psychiatry, Nursing and Midwifery Research Ethics Subcommittee of the College Research Ethics Committee (CREC) at Kings College London, 21/10/2016, ref: HR-16/17-3548

Study design

Intreventional feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Eligible participants will be randomised by the Kings Clinical Trials Unit (KCTU). Participants will be randomised using block randomisation via a web interface. Randomly varying block sizes will reduce the predictability of the sequence. There will be two arms and allocation will be 1:1.

Both interventions will be delivered via individual therapy sessions and consist of three to four sessions, delivered by a clinical psychologist. Sessions will last up to a maximum of 90 minutes, with the possibility of young people taking breaks during the session if needed.

‘Imagery-based cognitive behavioural intervention’ (ICBI): The intervention will combine components of (A) imagery rescripting to reduce the distress associated with negative images and build positive future images and (B) memory specificity training to increase specificity and access to memories. ICBI will follow a treatment manual and will be accompanied by a therapy workbook.

‘Non-directive supportive therapy’ (NDST): NDST will involve planned delivery of individual sessions with an empathic, concerned professional for emotional support and discussion of participant-initiated options for addressing problems. This intervention is designed to control for factors that, other than active components of therapy, could contribute to change such as the passage of time and non-specific aspects of therapy (e.g. speaking to an empathic therapist). NDST will follow treatment guidelines.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility outcome:
Feasibility and acceptability of the intervention is assessed by recording numbers of eligible participants, recruitment rate, retention rate outcome measure completion rate, data completeness, incidence of unexpected adverse events, data on adherence/compliance, and feedback questionnaires.

Secondary outcome measures

Principal clinical outcome
Depression is measured using the Mood and Feelings Questionnaire (MFQ; long version) pre-therapy, post-therapy and 3-month follow-up. (The short version of the MFQ will also be administered at each intervention session.)

Other measures
1. Anxiety is measured using the Screen for Child Anxiety Related Disorders pre-therapy, post-therapy and 3-month follow-up
2. Symptoms of post-traumatic stress are measured using the Revised Impact of Event Scale: child version pre-therapy, post-therapy and 3-month follow-up
3. Response style is measured using the Children’s Response Style Questionnaire pre-therapy, post-therapy and 3-month follow-up
4. Self-esteem is measured using the Rosenberg Self-Esteem Scale pre-therapy, post-therapy and 3-month follow-up
5. Self-Concept Clarity is measured using the Self-Concept Clarity scale pre-therapy, post-therapy and 3-month follow-up
6. Mental Imagery for future events is measured using the Prospective Imagery Task pre-therapy, post-therapy and 3-month follow-up
7. Memory specificity is measured using the Autobiographical Memory Task pre-therapy, post-therapy and 3-month follow-up
8. Daily mood is measured for seven days using daily mood ratings pre-therapy and post-therapy
9. Emotional response (subjective ratings and heart rate variability) to autobiographical memories is measured using a positive memory recall task pre-therapy and post-therapy

Overall trial start date

01/04/2015

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16-18
2. Informed consent
3. Willing and able to engage in psychological therapy and complete assessments
4. Scoring above clinical cut-off on Mood and Feelings Questionnaire (MFQ clinical cut-off ≥ 20).

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

56

Participant exclusion criteria

1. Diagnosis of learning disability or significant head injury, neurological disorder or epilepsy
2. Unable to fluently communicate in spoken English
3. Unable to give informed consent
4. Factors contra-indicating imagery rescripting, e.g. high levels of current risk
5. Currently receiving therapy
6. Experiencing psychotic symptoms or depressed in the postnatal period (participants with comorbid physical illness or non-psychotic disorders such as anxiety will not be excluded)

Recruitment start date

10/04/2017

Recruitment end date

31/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Institute of Psychiatry, Psychology and Neuroscience
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Guy’s Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Education England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication of trial protocol
2. Planned publication of outcomes to peer-reviewed journal within a year from end of trial.
3. Dissemination via conferences and to NHS services at a local level

IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from Dr Victoria Pile (victoria.pile@kcl.ac.uk)

Intention to publish date

31/05/2020

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes