Interpersonal counselling for adolescent low mood
| ISRCTN | ISRCTN82180413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82180413 |
| IRAS number | 268403 |
| Secondary identifying numbers | CPMS 44035, IRAS 268403 |
- Submission date
- 16/12/2019
- Registration date
- 31/12/2019
- Last edited
- 24/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Mr Tom Rhodes
tom.rhodes@nsft.nhs.uk
2. Dr Jon Wilson
jon.wilson@nsft.nhs.uk
Contact information
Public
Norfolk and Suffolk NHS Foundation Trust
Research Department
Frank Curtis Library
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom
| Phone | +44 (0)7880 135 615 |
|---|---|
| tom.rhodes@nsft.nhs.uk |
Scientific
Norfolk and Suffolk NHS Foundation Trust
Research Department
Frank Curtis Library
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
United Kingdom
 ORCID ID |
0000-0002-5279-6237 |
|---|---|
| Phone | +44 (0)7917880357 |
| jon.wilson@nsft.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Interpersonal counselling for adolescent depression delivered by youth mental health workers without core professional training: a feasibility randomised controlled trial |
| Study acronym | ICALM |
| Study objectives | It will be feasible to implement the IPC-A intervention and evaluate its effectiveness and cost-effectiveness in a randomised controlled trial |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2019 |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 82; UK Sample Size: 82 |
| Total final enrolment | 16 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/01/2020 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Drayton High Road
Norwich
NR6 5BE
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Bonnie Teague
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
England
United Kingdom
| Phone | +44 (0)1603421255 |
|---|---|
| bonnie.teague@nsft.nhs.uk | |
| Website | http://www.nsft.nhs.uk/ |
"ROR" |
https://ror.org/03400ft78 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/12/2020 | 11/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Preprint (other) | Lessons learned from process evaluation | 09/08/2023 | 14/08/2023 | No | No |
| Other publications | qualitative mixed methods process evaluation | 23/01/2024 | 24/01/2024 | Yes | No |
Editorial Notes
24/01/2024: Publication reference added.
14/08/2023: Preprint reference added.
20/09/2022: The intention to publish date was changed from 30/09/2022 to 31/03/2023.
31/03/2022: The total final enrolment number has been added.
20/12/2021: The recruitment end date was changed from 31/12/2021 to 28/02/2022.
28/09/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2021 to 31/12/2021.
2. The overall trial end date was changed from 30/09/2021 to 30/09/2022.
3. The intention to publish date was changed from 01/09/2021 to 30/09/2022.
4. Contact details updated.
11/12/2020: Publication reference added.
07/12/2020: The following changes have been made:
1. Recruitment has resumed.
2. The public contact has been changed and the plain English summary updated accordingly.
04/12/2020: The recruitment end date has been changed from 21/12/2020 to 30/06/2021.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
16/12/2019: Trial's existence confirmed by the NIHR.
