The developing core adolescent emotional skills (DECADES) study
| ISRCTN | ISRCTN14329613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14329613 |
- Submission date
- 19/05/2021
- Registration date
- 08/06/2021
- Last edited
- 17/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There are lots of ways in which we can help people improve how they manage their emotions, and that this can impact how they understand their emotions and experiences. We will be investigating how learning specific skills can impact on mental health and wellbeing.
Who can participate?
This study is open to anyone aged 16-19 years, provided that you have access to a smart phone and the internet. Participation also requires that individuals be (1) not participate in a regular yoga and/or mindfulness class/workshop, (2) they not have participated in prior meditation training or a mindfulness-based stress reduction course, (3) are not experiencing chronic illness (e.g. epilepsy, chronic pain, cancer), (4) they lack fluency in English (5) do not have a recent diagnosis of, and are currently receiving medical/psychological treatment for, a mental health condition including (but not limited to) anxiety disorder, major depressive disorder or a traumatic stress disorder and (6) do not have a diagnosis of a neurodevelopmental condition such as Autism Spectrum Disorder or Attention Deficit/Hyperactivity Disorder.
What does the study involve?
The study involves 4 things. (1) Skills Training: You will be given a range of materials (including audio files, videos, and computer tasks) that will help you practice skills relating to understanding your emotions and experiences. You will need to do these each day. Each skills session will last about 10-15 minutes. (2) Short daily surveys: You will have an app downloaded to your phone. The app will ask you to answer certain questions throughout the day, and at the end of the day. (3) Questionnaires: We want to understand the impact that the skills training has on mental health and well-being. For that reason, you will be asked to complete questionnaires exploring your emotions, mood, mental health and well-being. This will involve some questions that are sensitive in nature. You will be asked to do these longer questionnaires about once a week. (4) Computer based tasks: At several points during the study, we will ask you to take part in some computer based tasks that you will be able to access online. These should take about half an hour each time you do them. The study is entirely remote. It is self-guided based on an App and website link that can be accessed using a laptop/PC.
What are the benefits and risks of participating?
None
Where is the study run from?
Medical Research Council - Cognition and Brain Sciences Unit, University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
February 2020 to December 2022
Who is the funder?
This project is funded by Wellcome Trust Strategic Award (co-led by Dr. Tim Dalgleish) (UK)
Who is the main contact?
Ms. Rachel Knight (Rachel.knight@mrc-cbu.cam.ac.uk)
Contact information
Scientific
MRC-Cognition and Brain Sciences unit
University of Cambridge
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
 ORCID ID |
0000-0001-7217-4059 |
|---|---|
| Phone | +44 (0)1223 355294 |
| marc.pat.bennett@gmail.com |
Scientific
MRC-Cognition and Brain Sciences unit
University of Cambridge
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| Phone | +44 (0)1223 355294 |
|---|---|
| rachel.knight@mrc-cbu.cam.ac.uk |
Scientific
MRC-Cognition and Brain Sciences unit
University of Cambridge
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| Phone | +44 (0)1223 355294 |
|---|---|
| tim.dalgleish@mrc-cbu.cam.ac.uk |
Study information
| Study design | Randomized controlled feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Protocol for a randomized controlled trial investigating an intervention to boost decentering in response to distressing mental experiences during adolescence: The Decentering in Adolescence Study (DECADES) |
| Study acronym | DECADES |
| Study objectives | This study will answer the following research questions: 1a. Is decentering training during adolescence associated with increased decentering reports relative to an active control condition? 1b. Is decentering training during adolescence associated with increased decentering in response to negative mental events relative to an active control condition? 2a. What is the impact of decentering training on youth mental health relative to an active control condition? 2b. What is the impact of decentering training on emotional reactivity towards momentary negative mental events relative to an active control? 3. What are the cognitive correlates of decentering training during adolescence? |
| Ethics approval(s) | Approved 03/02/2020, Cambridge Psychology Research Ethics Committee (School of the Biological Sciences, 17 Mill Lane, Cambridge, CB2 1RX, UK; +44(0)1223 766894; Cheryl.Torbett@admin.cam.ac.uk), ref: PRE:2019.109 |
| Health condition(s) or problem(s) studied | To improve decentering and reduce psychological distress in a sample of young people at risk of depression |
| Intervention | Decentering training. A 5-week psychological decentering training programme was developed based on our previous protocol. This involves audio-recorded scripts and an accompanying work book that guides participants through four types of decentering technique; this structure is partly based on a recent taxonomy of self-distancing (a construct closely related to decentering). The decentering techniques include: (Week 1) spatial distancing wherein individuals are taught to re-imagine negative memories from a physically distant perspective (e.g. ‘replay the memory but as if you’re a fly on the wall’); (Week 2) verbal distancing/cognitive defusion wherein individuals are taught to re-phrase negative self-relevant statements in a way that challenges its literal value and influence over affective behavior (e.g. replacing first person pronouns with one’s name); (Week 3) temporal distancing wherein individuals are taught to re-consider specific worries from a temporally distant future (e.g. ‘how would this seem in 5 years?’); and (Week 4) objective distancing wherein individuals are taught to adopt a third-person perspective towards negative memories. Week 5 is a revision week. These techniques were selected since they are directly targeted at how adolescents relate to and observe day-to-day psychological stressors. Specifically, the goal is to teach adolescents concrete ways to generate an objective (or distanced) self-perspective in response to everyday feelings, thoughts and memories that are unpleasant. We assume this training will develop participants’ decentering ability above their baseline levels. Each week will involve 5 audio-recorded exercises (10-15 minutes) that will be made available using common streaming services. One exercise will be posted each weekday, Monday to Friday. The first two exercises (Monday and Tuesday) are brief mindfulness-based grounding exercises designed to promote open monitoring of psychological experiences and stressors. The next three exercises (Wednesday to Friday) are decentering training exercises as described above. Adherence to the programme will be encouraged by directly contacting the participants in week 1 and week 3 to discuss their experiences so far and allow troubleshooting. Participant engagement will be monitored by reviewing the number of completed workbook exercise at the end of the five weeks. Participants will also complete daily diaries. These will include five questions about the intervention and its application, such as “Did you complete any of the programme exercises today?” or “During the day, were you able to apply the skills you've learned from the exercises?”. A participant’s engagement in the trial will be discontinued if they elect to withdraw their participation or if they experience serious physical/mental health difficulties that necessitate medical or psychological intervention. Physical and cognitive exercise. A five week active control programme was developed as an active control condition. This contains two elements that roughly match the decentering training for time and cognitive engagement. First, guided physical movement routines will be completed in lieu of mindfulness grounding exercises (Monday-Tuesday). These movements are intended to emulate the physiological nature of grounding exercises but without an internal focus. Participants will watch short videos in which one member of the research team illustrates a basic series of body stretches. Accompanying audio provides additional direction and this was recorded using the same voices from the decentering training programme. Each video comprises 15 stretches, with each stretch held for 30 seconds and a 10 second break between stretches. The physical movements were selected for their ease and accessibility. Care was also taken to select movements that are safe and cater to a range of physical abilities. Second, gamified versions of standard cognitive tasks will be completed in lieu of the decentering training (Wednesday-Friday). These games are intended to emulate the cognitive effort associated with decentering exercises. Each participant will have a link that allows them to select one of three games, which can be completed on a personal smart phone (for game outlines, see https://osf.io/aw6c5). Games include: (1) a Multi-Target Visual Search Task wherein participants search and respond to specific targets within a broader stimulus array; (2) a Go/NoGo Task wherein a speeded response is made in response to a ‘go’ signal but inhibited in response to a ’no go’ signal: and (3) a Digit Recall Task wherein participants must recall a sequence on a number pad (i.e. a digit-span task). Adherence to the programme will be encouraged by contacting the participants in week 1 and week 3 to discuss their experiences. Engagement will be monitored by reviewing task completion rates and performance measures (response times and accuracy) at the end of the five weeks. Following baseline assessment, participants will be stratified according to sex and depression severity (using the CES-D). They will then be randomly assigned to either the decentering training programme or the active control condition. This will be managed by the trial statistician using a minimization procedure. Participant allocation will be then shared with the research coordinator responsible for providing appropriate access links for the online intervention. Blinding at this stage is not possible as the trial is a psychological intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-rated decentering as measured by the Experiences Questionnaire (EQ) at baseline, mid-intervention, and post-intervention |
| Secondary outcome measures | 1. The situational use of decentering will be examined using Experience Sampling Methods (ESM). Two ESM items have been developed to estimate the momentary use of decentering in response to psychological stressors like difficult feelings, memories, or thoughts. ESM items will be delivered four times daily across a five day ESM baseline period and the five weeks of training. 2. Anxiety will be measured using the Revised Child Anxiety and Depression Scale-Short Version (RCADS-15) at baseline, mid-intervention, and post-intervention. 3. Depression will be measured using the Centre for Epidemiology Depression Scale (CES-D) at baseline, mid-intervention, and post-intervention. 4. Anger will be measured using the State-Trait Anger Expression Inventory-2 Child and Adolescent (STAXI-2) at baseline, mid-intervention, and post-intervention. 5. Psychological wellbeing will be measured using the Warwick Edinburgh Mental Well Being Scale (WEMWBS) at baseline, mid-intervention, and post-intervention 6. Psychosocial strengths/difficulties will be measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline and post-intervention |
| Overall study start date | 03/02/2020 |
| Completion date | 23/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | Two groups of older adolescents (n = 57 per group; age range = 16–19 years) |
| Total final enrolment | 114 |
| Key inclusion criteria | Current inclusion criteria as of 21/12/2021: 1. Older adolescents (aged 16 - 19 years) 2. Access to a laptop/desktop computer and a personal smartphone device 3. Elevated Risk Group: Score of 16 or above on the Centre for Epidemiological Studies - Depression measure. Previous inclusion criteria: 1. Older adolescents (aged 16 - 19 years) 2. Access to a laptop/desktop computer and a personal smartphone device |
| Key exclusion criteria | 1. Currently take part in a regular yoga and/or mindfulness class/workshop 2. Have participated in prior meditation training or a mindfulness-based stress reduction course 3. Currently experiencing chronic illness (e.g. epilepsy, chronic pain, cancer) 4. Lack fluency in English 5. Have a recent diagnosis of, and are currently receiving medical/psychological treatment for, a mental health condition including (but not limited to) anxiety disorder, major depressive disorder or a traumatic stress disorder 6. Have a diagnosis of a neurodevelopmental condition such as Autism Spectrum Disorder or Attention Deficit/Hyperactivity Disorder |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
Sponsor information
Research council
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| Phone | +44 (0)1223 355294 |
|---|---|
| tim.dalgleish@mrc-cbu.cam.ac.uk | |
| Website | http://www.mrc-cbu.cam.ac.uk/ |
"ROR" |
https://ror.org/055bpw879 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The findings of this study will be disseminated through typical academic routes including poster/paper presentations at (inter)-national conferences, academic institutes and through publication in peer-reviewed journals. Given that some research questions are less exploratory than others, two key manuscripts are planned for the trial data. The first will describe the impact of training on self-rated decentering and mental health outcomes. The second will describe the exploratory research around the impact on cognitive performance measures. Findings will also be disseminated to the broader public through seminars and workshops with relevant stakeholders as well as online blogs and podcasts. These manuscripts will be completed and submitted for review irrespective of the nature of the observed effects. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. Following the publication of the first manuscript, a fully anonymized dataset will be made available online on open-access databases whose servers are located within the UK or Europe. Data processing scripts and programming codes will also be made available online. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 30/03/2022 | 07/12/2022 | Yes | No | |
| Preprint results | 11/12/2023 | 15/01/2024 | No | No | |
| Statistical Analysis Plan | version 2 | 20/04/2023 | 15/01/2024 | No | No |
| Basic results | 15/01/2024 | 17/01/2024 | No | No |
Additional files
Editorial Notes
14/01/2024: Basic results uploaded.
15/01/2024: Preprint and statistical analysis plan added.
07/12/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2022 to 23/12/2022.
2. The intention to publish date was changed from 31/12/2023 to 30/06/2024.
07/12/2022: Protocol added.
20/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 30/11/2022.
2. The overall trial end date was changed from 31/07/2022 to 31/12/2022.
3. The intention to publish date was changed from 01/10/2022 to 31/12/2023.
11/02/2022: The following changes have been made:
1. The target number of participants has been changed from "Two groups of older adolescents (n = 48 per group; age range = 16–19 years)" to "Two groups of older adolescents (n = 57 per group; age range = 16–19 years)" and the total target enrolment has been changed from 96 to 114.
2. The total final enrolment number has been changed from 96 to 114.
24/01/2022: Contact details updated.
04/01/2022: The overall trial end date has been changed from 01/06/2022 to 31/07/2022.
21/12/2021: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The recruitment end date was changed from 10/06/2022 to 30/06/2022.
14/12/2021: The recruitment end date was changed from 01/12/2021 to 10/06/2022.
09/08/2021: The recruitment start date was changed from 01/06/2021 to 01/09/2021.
19/05/2021: Trial's existence confirmed by Cambridge Psychology Research Ethics Committee.
