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Development of Transdiagnostic Single-session Treatment

Not Applicable
Recruiting
Conditions
Stress Disorder
Depression
Anxiety Disorders
Interventions
Behavioral: Transdiagnostic single-session treatment
Registration Number
NCT05784259
Lead Sponsor
Luleå Tekniska Universitet
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment groupTransdiagnostic single-session treatmentTransdiagnostic single-session treatment
Primary Outcome Measures
NameTimeMethod
Mindfulness post-treatment3 weeks post-treatment

Measured using FFMQ, mindfulness

Alexithymia post-treatment3 weeks post-treatment

Measured using TAS-20, mindfulness

Generalization6 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.

Anxiety, Depression and Stress symptoms post-treatment3 weeks post-treatment

Measured using DASS-21

Anxiety sensitivity post-treatment3 weeks post-treatment

Measured using BSQ, fear of bodily sensations related to anxiety

Experiential avoidance post-treatment3 weeks post-treatment

Measured using AFQ-Y8, psychological flexibility

Experiential avoidance follow-up6 months post-treatment

Measured using AFQ-Y8, psychological flexibility

Alexithymia follow-up6 months post-treatment

Measured using TAS-20, mindfulness

Anxiety, Depression and Stress symptoms follow-up6 months post-treatment

Measured using DASS-21

Anxiety sensitivity follow-up6 months post-treatment

Measured using BSQ, fear of bodily sensations related to anxiety

Mindfulness follow-up6 months post-treatment

Measured using FFMQ, mindfulness

Secondary Outcome Measures
NameTimeMethod
Additional treatment6 months post-treatment

It will be recorded if patients sought additional care after single-session treatment as well as type of care.

Trial Locations

Locations (1)

Region Norrbotten, Primary care

🇸🇪

Luleå, Norrbotten, Sweden

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