Development of Transdiagnostic Single-session Treatment

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

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?

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety Disorders; Stress Disorder
• Intervention / Treatment: Behavioral: Transdiagnostic single-session treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Näsling, Master; Phone Number: +4673 080 77 67; Email: john.nasling@ltu.se

Study Locations

• Sweden
  • Norrbotten
    • Luleå, Norrbotten, Sweden
      • Recruiting
      • Region Norrbotten, Primary care
      • Contact: John Näsling; Phone Number: 0730807767; Email: john.nasling@ltu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Treatment group; Transdiagnostic single-session treatment	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Luleå Tekniska Universitet
• Collaborators: Region Norrbotten
• Investigators: Principal Investigator: John Näsling, Master, Luleå tekniska universitet/Region Norrbotten

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: transdiagnostic; single-session
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 275863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No