Understanding your vulnerabilities
| ISRCTN | ISRCTN16730956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16730956 |
| Secondary identifying numbers | 38967 |
- Submission date
- 13/11/2023
- Registration date
- 15/11/2023
- Last edited
- 15/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many young adults with substance use disorder experience internalizing symptoms such as anxiety and depression in addition to their substance use. Comprehensive integrated treatments may not be feasible for practical reasons, or because patients are not well-prepared to engage in such treatment. Brief psycho-education may help prepare patients for more comprehensive care, or to benefit from treatment that focuses on only substance use disorder or only mental health problems, in spite of the comorbidity. This study aims to assess the acceptability and feasibility of brief psycho-education.
Who can participate?
People aged 18 to 30 years old enrolled in treatment for substance use disorder at the participating site
What does the study involve?
The study involves receiving either standard treatment with cognitive behavioral counselling and motivational interviewing or standard treatment with six sessions of integrated psycho-education. All patients will have access to the same pharmacological and wrap-around services in addition to counselling, regardless of randomization.
What are the possible benefits and risks of participating?
The potential benefits of participating are to have a better treatment experience and improved outcomes. While any study carries risks, the Ethics Committee for the Central Jutland Region has not identified significant risks.
Where is the study run from?
The Municipality of Gladsaxe (Denmark)
When is the study starting and how long is it expected to run for?
January 2021 to June 2025
Who is funding the study?
Trygfonden, a Danish research fund
Who is the main contact?
Morten Hesse (Associate Professor at the Centre for Alcohol and Drug Research, Aarhus University), mh.crf@psy.au.dk
Contact information
Scientific, Principal Investigator
Tuborgvej 164
Copenhagen NV
2450
Denmark
 ORCID ID |
0000-0002-6849-6554 |
|---|---|
| Phone | +4521664936 |
| mh.crf@psy.au.dk |
Public, Scientific
Tuborgvej 164
Copenhagen
2450
Denmark
| ORCID ID |
0000-0001-5658-5392 |
|---|---|
| Phone | +4587165336 |
| bt.crf@psy.au.dk |
Study information
| Study design | Two-arm pilot feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Other therapist office |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet in Danish, or a translation into English |
| Scientific title | Brief psychoeducation for comorbid alcohol and other drug use disorders and internalizing symptoms |
| Study acronym | PsyCom |
| Study objectives | Brief psychoeducation on internalizing problems will be acceptable and feasible in the context of outpatient treatment for substance use disorders |
| Ethics approval(s) |
Approved 05/12/2022, The Scientific Ethics Committees for the Central Jutland Region (Skottenborg 26, Viborg, 8800, Denmark; +45 7841 0183; komite@rm.dk), ref: 1-10-72-113-22 |
| Health condition(s) or problem(s) studied | Substance use disorder and internalizing symptoms |
| Intervention | This study will investigate treatment as usual plus psychoeducation versus treatment as usual alone for comorbid substance use disorders and internalizing symptoms. For both interventions, the municipality is responsible for providing psychosocial and pharmacological treatment for substance use disorders. In the experimental arm, the clients are offered six sessions of psychoeducation focusing on the overlap between internalizing symptoms and substance use. Many emerging adults (18-30 years old) with alcohol and other drug use disorders (AOD) suffer from concurrent symptoms of anxiety or depression, often referred to as internalizing disorders. However, the provision of good care is challenged because of the limited availability of relevant treatment options that can easily be implemented and managed in clinical practice. Considering the high risk of severe consequences across life areas for these emerging adults, it is of great importance to develop innovative brief evidence-based interventions that engage them at an early stage when they enroll in AOD treatment. There is a flyer to inform participants about the study; informed consent; information material from the National Scientific Ethics Committees (as part of informed consent material); a workbook on the experimental conditions (can be made available by request); standard treatment (can be made available by request). During the first in-person contact, social workers and/or nurses at the participating treatment site will assess whether an individual is eligible for study participation according to the eligibility criteria. If the individual is deemed eligible, the same employee will verbally inform the individual about the trial and provide a participant information sheet, including material on informed consent and material from the National Scientific Ethics Committees. If the individual accepts the invitation and gives informed consent for study participation, the employee will collect the necessary information for randomization in an online questionnaire, which is forwarded to the Center for Alcohol and Drug Research (CADR), at Aarhus University, via an anonymous and secure email. The research team will ensure the confidentiality of this data by keeping the online questionnaire data and consent forms on secure servers. Information on randomization will be sent by the research team within the same day or the next day by secure mail to the treatment site, which will initiate the start of the treatment sessions in the study arm that is given by the randomization. Treatment will start. All treatment providers at the participating site have a BA in social work, nursing, or a related field. Two counsellors with an education in social work will provide the experimental condition and have been trained in this by the researchers, who are available for questions throughout the study period. Standard treatment will be provided by all other counsellors at the treatment site. These counsellors also have educational background in social work/nursing and are trained in providing the standard treatment. Supervision is given to all counsellors by a psychologist at the site when needed. Both interventions are provided face-to-face at the treatment site. Both interventions are individual counselling. The study takes place at the participating treatment site; an outpatient treatment site in Gladsaxe municipality; Denmark. The intervention occurred in therapy rooms within the community clinic for substance use disorders. The study is randomized using the minimization method with balancing on gender, age (25<age<30), and employment or training (versus none). All treatment providers have a BA in social work, nursing, or a related field. For the experimental group, treatment providers practised the psychoeducation using extensive roleplay. |
| Intervention type | Behavioural |
| Primary outcome measure | The expectation of a good outcome measured using the Outcome Expectancies Questionnaire at 1 and 3 months post-randomization |
| Secondary outcome measures | 1. Symptoms of anxiety and depression measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) at 1 and 3 months 2. Level of functioning measured using the WHO Disability Assessment Schedule-5 (WHODAS-5) at 1 and 3 months 3. Knowledge of internalizing symptoms measured using qualitative interviews at the 3-month follow-up 4. Retention and treatment attendance measured using an electronic logbook to assess treatment attendance at each session, including no-shows and cancellations. Retention will be measured using time-to-event models at the time of the latest discharge from treatment, or December 31st 2024, whichever occurs first. 5. Days abstinent measured using the MapPlan at 1 and 3 months 6. Acute psychiatric care measured using both case files and interview data at 1 and 3 months post-randomization |
| Overall study start date | 31/01/2021 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Seeking treatment for substance use disorder 2. Reporting 3 or more points on the Youthmap internalizing problems |
| Key exclusion criteria | Psychotic disorders |
| Date of first enrolment | 17/08/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Søborg
2860
Denmark
Sponsor information
University/education
Bartholins Allé 10
Aarhus C
8000
Denmark
| Phone | +4587165313 |
|---|---|
| crf@au.dk | |
| Website | https://psy.au.dk/en/research/research-centres-and-units/centre-for-alcohol-and-drug-research |
"ROR" |
https://ror.org/01aj84f44 |
Hospital/treatment centre
Østmarken 4
Søborg
2860
Denmark
| Phone | +4539573900 |
|---|---|
| rusmidler@gladsaxe.dk | |
| Website | https://gladsaxe.dk/kommunen/borger/sundhed-og-sygdom/misbrug-af-alkohol-og-rusmidler/gladsaxe-rusmiddelcenter |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- TrygFonden Kystlivredning
- Location
- Denmark
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publications in high-impact and peer-reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Morten Hesse, mh.crf@psy.au.dk. Data will be stored pseudonymized at Statistics Denmark's servers. Data will be the primary and secondary outcomes from the interviews only, not from the logbook. Data will be made available six months after the study has ended in aggregated format with cells of no less than 5 patients. Consent to share has not been collected. Ethical and legal restrictions mean that only aggregate data will be shared. Changes in legislation up to the request for raw data may influence the sharing of data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 30/08/2021 | 14/11/2023 | No | No |
Additional files
Editorial Notes
14/11/2023: Study's existence confirmed by the Scientific Ethics Committees for the Central Jutland Region (Denmark).
