NCT05784259

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

March 13, 2023

Last Update Submit

December 11, 2023

Conditions

Anxiety DisordersDepressionStress Disorder

Keywords

transdiagnosticsingle-session

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (1)

  • Additional treatment

    6 months post-treatment

Study Arms (2)

Control group

NO INTERVENTION

Treatment group

EXPERIMENTAL

Transdiagnostic single-session treatment

Behavioral: Transdiagnostic single-session treatment

Interventions

Transdiagnostic single-session treatmentBEHAVIORAL

Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the criteria for anxiety, mood disorder, or stress diagnosis
  • Symptoms are mild to moderate in severity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Norrbotten, Primary care

Luleå, Norrbotten County, Sweden

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorTrauma and Stressor Related Disorders

Study Officials

  • John Näsling, Master

    Luleå tekniska universitet/Region Norrbotten

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Näsling, Master

CONTACT

+4673 080 77 67john.nasling@ltu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lic. psychologist / Doctoral student

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)