Development of Transdiagnostic Single-session Treatment

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784259
• Other study ID #: 275863
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Luleå Tekniska Universitet
• Contact: John Näsling, Master
• Phone: +4673 080 77 67
• Email: john.nasling[@]ltu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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?

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Stress Disorder

Intervention

Behavioral:
• Transdiagnostic 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

Locations

Country	Name	City	State
Sweden	Region Norrbotten, Primary care	Luleå	Norrbotten

Sponsors (2)

Lead Sponsor	Collaborator
Luleå Tekniska Universitet	Region Norrbotten

Country where clinical trial is conducted

Sweden, 

Outcome

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