Development of Transdiagnostic Single-session Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders, Depression, Stress Disorder

Intervention / Treatment
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* Behavioral: Transdiagnostic single-session treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Treatment group<br>Transdiagnostic single-session treatment | Behavioral: Transdiagnostic single-session treatment<br>* Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety, Depression and Stress symptoms post-treatment | Measured using DASS-21 | 3 weeks post-treatment | 
| Anxiety, Depression and Stress symptoms follow-up | Measured using DASS-21 | 6 months post-treatment | 
| Anxiety sensitivity post-treatment | Measured using BSQ, fear of bodily sensations related to anxiety | 3 weeks post-treatment | 
| Anxiety sensitivity follow-up | Measured using BSQ, fear of bodily sensations related to anxiety | 6 months post-treatment | 
| Experiential avoidance post-treatment | Measured using AFQ-Y8, psychological flexibility | 3 weeks post-treatment | 
| Experiential avoidance follow-up | Measured using AFQ-Y8, psychological flexibility | 6 months post-treatment | 
| Mindfulness post-treatment | Measured using FFMQ, mindfulness | 3 weeks post-treatment | 
| Mindfulness follow-up | Measured using FFMQ, mindfulness | 6 months post-treatment | 
| Alexithymia post-treatment | Measured using TAS-20, mindfulness | 3 weeks post-treatment | 
| Alexithymia follow-up | Measured using TAS-20, mindfulness | 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. | 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional treatment | It will be recorded if patients sought additional care after single-session treatment as well as type of care. | 6 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transdiagnostic, single-session