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Development of Transdiagnostic Single-session Treatment

Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05784259
Enrollment
300
Registered
2023-03-24
Start date
2023-10-01
Completion date
2025-01-31
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depression, Stress Disorder

Keywords

transdiagnostic, single-session

Brief 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 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.

Interventions

BEHAVIORALTransdiagnostic single-session treatment

Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation

Sponsors

Region Norrbotten
CollaboratorUNKNOWN
Luleå Tekniska Universitet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Meet the criteria for anxiety, mood disorder, or stress diagnosis * Symptoms are mild to moderate in severity

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Generalization6 months post-treatmentQualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.
Anxiety, Depression and Stress symptoms post-treatment3 weeks post-treatmentMeasured using DASS-21
Anxiety, Depression and Stress symptoms follow-up6 months post-treatmentMeasured using DASS-21
Anxiety sensitivity post-treatment3 weeks post-treatmentMeasured using BSQ, fear of bodily sensations related to anxiety
Anxiety sensitivity follow-up6 months post-treatmentMeasured using BSQ, fear of bodily sensations related to anxiety
Experiential avoidance post-treatment3 weeks post-treatmentMeasured using AFQ-Y8, psychological flexibility
Experiential avoidance follow-up6 months post-treatmentMeasured using AFQ-Y8, psychological flexibility
Mindfulness post-treatment3 weeks post-treatmentMeasured using FFMQ, mindfulness
Mindfulness follow-up6 months post-treatmentMeasured using FFMQ, mindfulness
Alexithymia post-treatment3 weeks post-treatmentMeasured using TAS-20, mindfulness
Alexithymia follow-up6 months post-treatmentMeasured using TAS-20, mindfulness

Secondary

MeasureTime frameDescription
Additional treatment6 months post-treatmentIt will be recorded if patients sought additional care after single-session treatment as well as type of care.

Countries

Sweden

Contacts

Primary ContactJohn Näsling, Master
john.nasling@ltu.se+4673 080 77 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026