Anxiety DisordersNCT05784259
Development of Transdiagnostic Single-session Treatment
A study testing Transdiagnostic single-session treatment in people with Anxiety Disorders and Depression, run by Luleå Tekniska Universitet at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is: Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress? Will the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression, Stress Disorder
- What is being tested?
- Transdiagnostic single-session treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the criteria for anxiety, mood disorder, or stress diagnosis
- Symptoms are mild to moderate in severity
Who cannot join
- Already in ongoing psychotherapy
- Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose
- Has a comorbid personality disorder
- Has a risk of suicide deemed other than low
- Has other severe psychological disorders outside the scope of primary care
- Is in a severely stressful social situation deemed incompatible with psychotherapy
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Norrbotten, Primary care
Luleå, Norrbotten County
John Näsling, 0730807767, john.nasling@ltu.se
About this study
Official title: Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:
- Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?
- Will the transdiagnostic treatment program decrease transdiagnostic risk factors?
- Will the transdiagnostic treatment program decrease the measured risk factors equally?
- Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?
- Have the participants been able to generalize the skills taught in the program(qualitative)?
- Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?
Read the detailed description
The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.
The treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.
The study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.
- Conditions
- Anxiety Disorders, Depression, Stress Disorder
- Being tested
- Transdiagnostic single-session treatment
- Keywords
- transdiagnostic, single-session
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic single-session treatmentBehavioural
Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Treatment group | Experimental | Transdiagnostic single-session treatment Receives: Behavioral: Transdiagnostic single-session treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety, Depression and Stress symptoms post-treatment
Measured using DASS-21
Measured: 3 weeks post-treatment
Anxiety, Depression and Stress symptoms follow-up
Measured using DASS-21
Measured: 6 months post-treatment
Anxiety sensitivity post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Measured: 3 weeks post-treatment
Anxiety sensitivity follow-up
Measured using BSQ, fear of bodily sensations related to anxiety
Measured: 6 months post-treatment
Experiential avoidance post-treatment
Measured using AFQ-Y8, psychological flexibility
Measured: 3 weeks post-treatment
Experiential avoidance follow-up
Measured using AFQ-Y8, psychological flexibility
Measured: 6 months post-treatment
Mindfulness post-treatment
Measured using FFMQ, mindfulness
Measured: 3 weeks post-treatment
Mindfulness follow-up
Measured using FFMQ, mindfulness
Measured: 6 months post-treatment
Alexithymia post-treatment
Measured using TAS-20, mindfulness
Measured: 3 weeks post-treatment
Alexithymia follow-up
Measured using TAS-20, mindfulness
Measured: 6 months post-treatment
Generalization
Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.
Measured: 6 months post-treatment
Secondary outcomes (1)
Additional treatment
It will be recorded if patients sought additional care after single-session treatment as well as type of care.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Norrbotten
- Responsible party
- Principal investigator, John Näsling, Luleå Tekniska Universitet
- Investigators
- John Näsling, Master, Principal investigator, Luleå tekniska universitet/Region Norrbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784259
- Sponsor's protocol ID
- 275863
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
- ClinicalTrials.gov ID
- NCT05784259
- Acronym / sponsor ID
- 275863
- Conditions
- Anxiety Disorders, Depression, Stress Disorder
- Keywords
- transdiagnostic, single-session
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Collaborators
- Region Norrbotten
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:
- Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?
- Will the transdiagnostic treatment program decrease transdiagnostic risk factors?
- Will the transdiagnostic treatment program decrease the measured risk factors equally?
- Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?
- Have the participants been able to generalize the skills taught in the program(qualitative)?
- Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?
Detailed description
The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.
The treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.
The study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Treatment group | Experimental | Behavioral: Transdiagnostic single-session treatmentTransdiagnostic single-session treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the criteria for anxiety, mood disorder, or stress diagnosis
- Symptoms are mild to moderate in severity
Key exclusion criteria (6 listed)
- Already in ongoing psychotherapy
- Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose
- Has a comorbid personality disorder
- Has a risk of suicide deemed other than low
- Has other severe psychological disorders outside the scope of primary care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic single-session treatmentAdministered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation | Behavioural | Treatment group |
Primary outcome
Anxiety, Depression and Stress symptoms post-treatment
Time frame: 3 weeks post-treatment
Measured using DASS-21
Anxiety, Depression and Stress symptoms follow-up
Time frame: 6 months post-treatment
Measured using DASS-21
Anxiety sensitivity post-treatment
Time frame: 3 weeks post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Anxiety sensitivity follow-up
Time frame: 6 months post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Experiential avoidance post-treatment
Time frame: 3 weeks post-treatment
Measured using AFQ-Y8, psychological flexibility
Experiential avoidance follow-up
Time frame: 6 months post-treatment
Measured using AFQ-Y8, psychological flexibility
Mindfulness post-treatment
Time frame: 3 weeks post-treatment
Measured using FFMQ, mindfulness
Mindfulness follow-up
Time frame: 6 months post-treatment
Measured using FFMQ, mindfulness
Alexithymia post-treatment
Time frame: 3 weeks post-treatment
Measured using TAS-20, mindfulness
Alexithymia follow-up
Time frame: 6 months post-treatment
Measured using TAS-20, mindfulness
Generalization
Time frame: 6 months post-treatment
Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.
1 secondary outcome
Additional treatment
Time frame: 6 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Näsling, Master principal investigator
Luleå tekniska universitet/Region Norrbotten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic single-session treatment in people with Anxiety Disorders and Depression, run by Luleå Tekniska Universitet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Näsling, Master (+4673 080 77 67, john.nasling@ltu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety, Depression and Stress symptoms post-treatment (time frame: 3 weeks post-treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.