Evaluation of a psychological intervention for better oral health
| ISRCTN | ISRCTN15009620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15009620 |
| Secondary identifying numbers | n.a. |
- Submission date
- 06/03/2018
- Registration date
- 14/03/2018
- Last edited
- 19/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Oral health in adolescents and young adults is generally good, but there are subgroups with poor oral health, and there seems to be a strong link between socioeconomic status (SES) and oral health in adolescents and young adults. There is a need to develop more effective methods to change oral health behaviors, as conventional counseling methods are not always effective.
This study aims to investigate if a brief psychological intervention based on the acceptance and commitment therapy (ACT) is a possible way of promoting oral health, oral health behaviour and general psychological health in young adults, taking into account the individual socioeconomic status.
Who can participate?
Adults aged 18 – 25 years with two or more dental caries
What does the study involve?
Participants are randomly allocated to an intervention or control group. Both groups receive standardised oral health information, provided verbally by a registered dental nurse using a brochure on oral health behavious and caries.
Those in the intervention group also receive cognitive behavioural therapy based on acceptance and commitment therapy (ACT). This emphasises the participants own motivation to change by contacting their values and promoting committed action in line with those values. They receive two individual sessions (45 minutes each) with a licensed psychologist, delivered at their general dental clinic.
What are the possible benefits and risks of participating?
The participants may benefit from improved oral and general health. Whilst the intervention is assessed for adverse effects, no specific risks for the participants were expected.
Where is the study run from?
1. Dental Public Service Angered (Sweden)
2. Dental Public Service Vänersborg (Sweden)
When is the study starting and how long is it expected to run for?
February 2013 to May 2016
Who is funding the study?
Dental Public Service Region Västra Götaland (Sweden)
Who is the main contact?
Dr Ulla Wilde (Scientific)
ulla.wide@gu.se
Contact information
Scientific
Institute of Odontology
The Sahlgrenska Academy
University of Gothenburg
P.O. Box 450
Gothenburg
405 30
Sweden
 ORCID ID |
0000-0001-9498-1118 |
|---|---|
| Phone | +46 31 786 3076 |
| ulla.wide@gu.se |
Scientific
Institute of Odontology
The Sahlgrenska Academy
University of Gothenburg
P.O. Box 450
Gothenburg
405 30
Sweden
| Phone | +46 31 7863134 |
|---|---|
| hakeberg@gu.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Can a brief psychological intervention improve oral health behaviour? A randomised controlled trial. |
| Study hypothesis | 1. A brief psychological intervention (ACT) improves oral health behaviours (such as tooth-brushing and flossing) more than standard information alone 2. A brief psychological intervention (ACT) decreases distress and improves the ability to handle life stressors more than standard information alone. |
| Ethics approval(s) | Regional Ethical Review Board in Gothenburg Sweden, 03/12/2012, ref: 840-12 |
| Condition | Poor oral health (≥ two manifested proximal dental caries lesions) |
| Intervention | Participants are randomly allocated to an intervention or control group. Both groups receive standardised oral health information, provided verbally by a registered dental nurse using a brochure on oral health behavious and caries. Those in the intervention group also receive cognitive behavioural therapy based on acceptance and commitment therapy (ACT). This emphasises the participants own motivation to change by contacting their values and promoting committed action in line with those values. It also focuses on developing their willingness to experience different negative emotions, that have previously hindered this action to occur. They receive two individual sessions (45 minutes each) with a licensed psychologist specialising in ACT, delivered at their general dental clinic. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Oral health behaviour (tooth-brushing, flossing, tooth picks, additional fluoride) was measured by a self-report questionnaire using single-questions at baseline, 3 weeks, 9 weeks, 18 weeks and 1 year. 2. Oral health (caries, gingivitis) were measured by 2.1. radiographs for manifest caries at baseline and 1 year 2.2. clinical examination for gingivitis using bleeding on probing yes/no at baseline, 9 weeks, 18 weeks and 1 year. 3. Sugar consumption was measured using a self-report questionnaire of several items for consumption of soft drinks and candy/sweets at baseline, 9 weeks, 18 weeks and 1 year. |
| Secondary outcome measures | 1. Psychological distress and general health behaviour was assessed by a 1.1. self-report questionnaire (Hospital Anxiety and Depression Scale HADS) at baseline, 3 weeks, 9 weeks, 18 weeks and 1 year 1.2. self-report single questions (smoking, exercise) at baseline, 9 weeks, 18 weeks and 1 year. |
| Overall study start date | 27/02/2013 |
| Overall study end date | 31/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 135 |
| Participant inclusion criteria | 1. 18-25 years of age 2. ≥ two manifested proximal dental caries lesions 3. Good understanding of Swedish |
| Participant exclusion criteria | 1. Psychiatric/neuropsychiatric diagnosis, such as depression, psychosis, autism spectrum disorder, mental retardation, substance abuse. |
| Recruitment start date | 04/10/2013 |
| Recruitment end date | 19/01/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Angered
424 65
Sweden
Vänersborg
462 30
Sweden
Sponsor information
Government
Region Västra Götaland
Skövde
541 80
Sweden
| Phone | +46 10 4417000 |
|---|---|
| info.folktandvarden@vgregion.se | |
| Website | https://folktandvarden.vgregion.se |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Several publications in scientific peer-reviewed journals are planned within the coming year till 31/03/2019 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Associate professor Ulla Wide at ulla.wide@gu.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/10/2018 | 12/09/2019 | Yes | No |
| Results article | results | 26/08/2020 | 02/09/2020 | Yes | No |
| Results article | 18/11/2021 | 19/11/2021 | Yes | No | |
| Interim results article | Baseline data analysis | 31/07/2021 | 19/05/2023 | Yes | No |
Editorial Notes
19/05/2023: Publication reference added.
19/11/2021: Publication reference added.
02/09/2020: Publication reference added.
12/09/2019: Publication reference and total final enrolment added.
