A psychological programme to improve low mood in adolescence

ISRCTN	ISRCTN85369879
DOI	https://doi.org/10.1186/ISRCTN85369879
Protocol serial number	N/A
Sponsor	King's College London
Funders	Health Education England, National Institute for Health Research

Submission date: 03/04/2017
Registration date: 04/04/2017
Last edited: 07/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Victoria Pile
Public

Department of Psychology
Institute of Psychiatry, Psychology and Neuroscience
Kings College London
Denmark Hill
London
SE5 8AF
United Kingdom

ORCID ID	0000-0002-9177-2844
Phone	+44 (0)20 7848 0389
Email	victoria.pile@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Intreventional feasibility randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A brief early intervention for adolescent depression that targets emotional memories: a feasibility randomised controlled trial
Study acronym	IMAGINE
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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	Behavioural
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/05/2019

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	16 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	56
Total final enrolment	56
Key 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).
Key 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)
Date of first enrolment	10/04/2017
Date of final enrolment	31/05/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

Institute of Psychiatry, Psychology and Neuroscience
London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2021	08/06/2021	Yes	No
Protocol article	protocol	01/12/2018		Yes	No
Other publications		16/11/2021	07/06/2023	Yes	No
Other publications		23/08/2021	07/06/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/06/2023: Publication references added.
08/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
09/07/2018: Publication reference added.