Clinical trial NCT05784259: Development of Transdiagnostic Single-session Treatment
Official title: Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression
Stress Disorder
Keywords: transdiagnostic
single-session
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
Collaborators: name: Region Norrbotten
First posted: 2023-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety, Depression and Stress symptoms post-treatment
timeFrame: 3 weeks post-treatment
measure: Anxiety, Depression and Stress symptoms follow-up
timeFrame: 6 months post-treatment
measure: Anxiety sensitivity post-treatment
timeFrame: 3 weeks post-treatment
measure: Anxiety sensitivity follow-up
timeFrame: 6 months post-treatment
measure: Experiential avoidance post-treatment
timeFrame: 3 weeks post-treatment
measure: Experiential avoidance follow-up
timeFrame: 6 months post-treatment
measure: Mindfulness post-treatment
timeFrame: 3 weeks post-treatment
measure: Mindfulness follow-up
timeFrame: 6 months post-treatment
measure: Alexithymia post-treatment
timeFrame: 3 weeks post-treatment
measure: Alexithymia follow-up
timeFrame: 6 months post-treatment
measure: Generalization
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Additional treatment
timeFrame: 6 months post-treatment
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Region Norrbotten, Primary care
state: Norrbotten
Study officials:
affiliation: Luleå tekniska universitet/Region Norrbotten
name: John Näsling, Master
role: PRINCIPAL_INVESTIGATOR
References: