Plain English Summary
Background and study aims
Interpersonal Counselling (IPC) is a talking therapy for depression designed to be provided by staff who are not qualified mental health professionals. A version of IPC designed for young people (IPC for Adolescents: IPC-A) has been developed. Early work suggests that young people like IPC-A and it leads to reduced depressive symptoms. However, it is not known whether IPC-A is better at reducing depression symptoms than the normal support provided by non-specialist services, so the researchers to do a study to find out. Before they can do this, they need to run a smaller ‘feasibility’ study to answer questions about whether a larger study would be possible. This feasibility study will involve training local authority and charity staff members (without formal mental health qualifications) as IPC-A therapists.
Who can participate?
Young people aged 12-18 years seeking help for depression symptoms
What does the study involve?
Young people who consent are randomly allocated to receive either IPC-A or the support young people currently receive (“treatment as usual”) because, in the future trial, the researchers will need to do this to test in a fair way whether IPC-A is better than the support young people currently receive. All participants are invited to meet with a researcher to answer questions about their mental health and relationships, and are asked to complete questionnaires regularly during the study. Some participants are also invited to take part in interviews to help the researchers understand their experience of taking part. The results of the study will be shared with young people, participating services and commissioners, and will be used to design a future study testing whether IPC-A delivered by this staff group is better than usual support at reducing young people’s depressive symptoms.
What are the possible benefits and risks of participating?
Participants will receive a practical treatment for low mood (IPC-A) that would not otherwise be available to them. This treatment has been adapted from IPT which has been shown to be effective in other populations compared to TAU. However, because this revised version (IPC-A) has only recently begun to be explored, the researchers cannot guarantee that the therapy will benefit participants. Participants following the intervention will have access to usual care as suggested through typical care pathways. Participation in the research will involve thinking and talking about topics that some young people might find distressing, including difficult emotions and problems in their relationships with others. To reduce the risk of distress, research staff and those delivering the intervention will be trained in how to introduce potentially difficult topics sensitively, how to manage distress if it occurs and safeguard the safety and wellbeing of participants. While pilot work suggests that the intervention is safe and well accepted, the possibility of unintended consequences remains. All adverse events will be fully documented.
Where is the study run from?
Norfolk and Suffolk NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2019 to September 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Mr Gabriel Abotsie
Gabriel.abotsie@nsft.nhs.uk
2. Dr Paul Wilkinson
pow12@cam.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Gabriel Abotsie
ORCID ID
Contact details
Norfolk and Suffolk NHS Foundation Trust
Research and Development Department
Hellesdon Hospital
Norwich
NR6 5BE
United Kingdom
+44 (0)1603421126
Gabriel.abotsie@nsft.nhs.uk
Type
Scientific
Additional contact
Dr Paul Wilkinson
ORCID ID
http://orcid.org/0000-0003-3302-9662
Contact details
University of Cambridge
Department of Psychiatry
Douglas House
18b
Trumpington Road
Cambridge
CB2 8AH
United Kingdom
+44 (0)1223465255
pow12@cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 44035, IRAS 268403
Study information
Scientific title
Interpersonal counselling for adolescent depression delivered by youth mental health workers without core professional training: a feasibility randomised controlled trial
Acronym
ICALM
Study hypothesis
It will be feasible to implement the IPC-A intervention and evaluate its effectiveness and cost-effectiveness in a randomised controlled trial
Ethics approval
Approved 06/12/2019, East of England - Cambridge South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)207 104 8134; Email: nrescommittee.eastofengland-cambridgesouth@nhs.net), ref: 19/EE/0300
Study design
Randomised; Interventional; Design type: Treatment, Psychological & Behavioural
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Adolescent depression
Intervention
The ICALM study investigates the Interpersonal Counselling for Adolescents (IPC-A), a brief manualised psychological intervention, which helps clients to identify the reciprocal interaction between their current depressive symptoms and interpersonal relationships, with a focus on one of four domains: grief, relationship disputes, big changes and loneliness & isolation. The therapist works with the client to identify effective strategies to deal with their interpersonal problems, which should improve depressive symptoms. IPC-A is an adapted form of Interpersonal Counselling (IPC) designed to suit the needs of adolescents. The intervention is delivered over three to six (30-60 minute) sessions, depending on participant needs. This trial will investigate if IPC-A helps to reduce depressive symptoms of young people who participate in the study. As this is a feasibility study, we would also like to know if the methods employed in this trial can be used in a future larger trial.
To ensure we evaluate study outcomes in a fair and unbiased manner, young people who consent will be randomly allocated to receive either IPC-A or the support young people currently receive (“Treatment as Usual”[TAU]).
Eligible young people will complete a baseline assessment with the study research practitioner, including the other measures. Once the baseline assessment is complete, they will be randomly allocated to receive either IPC-A or TAU. Participants will be randomised in a 1:1 allocation ratio, using a stochastic minimisation algorithm to minimise imbalance between groups in baseline symptom severity, gender and study site. The Data Management Team at the Norwich Clinical Trials Unit (CTU) will manage allocation via a web-based system; it will not be accessible by anyone outside of this team, including the research team, trial therapists and participants; thus allocation concealment will be maintained. IPC-A arm participants will also have access to standard health and care provision throughout their participation; the extent to which provision of IPC-A alters use of these services will be monitored using the Client Service Receipt Inventory (CSRI).
All participants will be invited to meet with a researcher to answer questions about their mental health and relationships, and will be asked to complete questionnaires regularly during the study. Some participants will also be invited to take part in interviews to help understand their experience of taking part. All participants will be invited to complete a brief online assessment at 5 weeks post-randomisation and to take part in follow up assessments with a member of the research team at 10 and 23 weeks post-randomisation.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
This is a feasibility trial, and as such the primary output will be the design of the subsequent definitive trial. A number of feasibility outcomes will be assessed to facilitate this output, including recruitment and retention rates, fidelity of intervention implementation, degree of contamination of the control arm, suitability of the proposed measures, and acceptability of IPC-A from the point of view of young people, parents, staff and other key stakeholders.
The TSC will assess the trial against the following criteria and make recommendations regarding the suitability of the proposed design for the full-scale trial:
1. Recruitment rate is at least 80% of target
2. At least 70% of those randomised to receive the intervention attend at least three therapy sessions within the 10-week treatment window
3. Follow-up assessments are completed by at least 80% of participants at 10 weeks and 70% of participants at 23 weeks
4. At least 80% of IPC treatment sessions reviewed meet treatment fidelity criteria
5. Contamination of the control arm can be sufficiently limited for individual randomisation to be justified
6. The mean RCADS depression scores of the IPC-A and TAU groups at 10 weeks are indicative of a clinically significant difference in depression (3 points)
Secondary outcome measures
1. Presence of DSM depressive disorders measured using the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), depression section at baseline
2. Quality of family relationships of participants measured using the Family Assessment Device (FAD) at baseline, 5, 10, 23 weeks
3. Quality of peer relationships of participants measured using Cambridge Friendships Questionnaire (CFQ) at baseline, 5, 10, 23 weeks
4. Levels of inactivity amongst young people who are not in work, education or training measured using Employment, Education or Training in previous 4 weeks (NEET status) at baseline, 10, 23 weeks
5. Mental wellbeing of the research participants measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at baseline, 10, 23 weeks
6. Information on service utilisation, income, accommodation and other cost-related variables using the Modified Client Service Receipt Inventory(Modified-CSRI) at baseline, 10, 23 weeks
7. Health-related quality of life measured using the Child Health Utility 9D at baseline, 10, 23 weeks
Overall trial start date
01/10/2019
Overall trial end date
30/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Young people receiving treatment:
1. Aged 12-18 years
2. Seeking help for low mood (as the primary presenting difficulty)
3. Able to provide written informed consent or, for under 16s, written informed assent and parent/guardian consent
4. Of a level of illness where they would normally receive treatment from the service
Please note: this age range of 12-18 only applies to the young people receiving IPC. There will not be an age eligibility criterion for therapists/parents
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 82; UK Sample Size: 82
Participant exclusion criteria
Young people receiving treatment:
1. Learning disability necessitating non-mainstream schooling
2. Current psychotic disorder
3. Current substance dependence
4. Current significant suicidal ideation (K-SADS-PL – ‘suicidal ideation’ threshold – ‘often thinks of suicide and has thought of a specific method’)
Please note: there will not be a numerical upper severity threshold. The upper threshold comes under 'Of a level of illness where they would normally receive treatment from the service'. An interesting outcome of our initial IPC single-arm pilot was that some young people with severe depression (according to ratings questionnaires) are routinely treated by Suffolk Young Person's Services. Reasons are multiple. It is important to examine this in the wider range of services in the planned study. But the purpose of this study is not to examine/change referral thresholds but to investigate optimal treatments for young people in this service.
Recruitment start date
01/01/2020
Recruitment end date
21/12/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Norfolk and Suffolk NHS Foundation Trust
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom
Sponsor information
Organisation
Norfolk and Suffolk NHS Foundation Trust
Sponsor details
c/o Dr Bonnie Teague
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom
+44 (0)1603421255
bonnie.teague@nsft.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/112/16
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The researchers plan to publish the trial protocol in Trials journal. The results of the study will be shared with young people, participating services and commissioners, and will be used to design a future study testing whether IPC-A delivered by this staff group is better than usual support at reducing young people’s depressive symptoms.
1. Peer reviewed scientific journals
2. Internal report
3. Conference presentation
4. Social media
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to this being a feasibility trial; hence there will not be data that could be used for a useful and appropriately-powered secondary analysis.
Intention to publish date
01/09/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list