Development of Transdiagnostic Single-session Treatment

Sponsor
Luleå Tekniska Universitet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05784259
Collaborator
Region Norrbotten (Other)
300
2
12

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transdiagnostic single-session treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety, Depression and Stress symptoms post-treatment [3 weeks post-treatment]

    Measured using DASS-21

  2. Anxiety, Depression and Stress symptoms follow-up [6 months post-treatment]

    Measured using DASS-21

  3. Anxiety sensitivity post-treatment [3 weeks post-treatment]

    Measured using BSQ, fear of bodily sensations related to anxiety

  4. Anxiety sensitivity follow-up [6 months post-treatment]

    Measured using BSQ, fear of bodily sensations related to anxiety

  5. Experiential avoidance post-treatment [3 weeks post-treatment]

    Measured using AFQ-Y8, psychological flexibility

  6. Experiential avoidance follow-up [6 months post-treatment]

    Measured using AFQ-Y8, psychological flexibility

  7. Mindfulness post-treatment [3 weeks post-treatment]

    Measured using FFMQ, mindfulness

  8. Mindfulness follow-up [6 months post-treatment]

    Measured using FFMQ, mindfulness

  9. Alexithymia post-treatment [3 weeks post-treatment]

    Measured using TAS-20, mindfulness

  10. Alexithymia follow-up [6 months post-treatment]

    Measured using TAS-20, mindfulness

  11. Generalization [6 months post-treatment]

    Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.

Secondary Outcome Measures

  1. Additional treatment [6 months post-treatment]

    It will be recorded if patients sought additional care after single-session treatment as well as type of care.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Luleå Tekniska Universitet
  • Region Norrbotten

Investigators

  • Principal Investigator: John Näsling, Master, Luleå tekniska universitet/Region Norrbotten

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Näsling, Lic. psychologist / Doctoral student, Luleå Tekniska Universitet
ClinicalTrials.gov Identifier:
NCT05784259
Other Study ID Numbers:
  • 275863
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John Näsling, Lic. psychologist / Doctoral student, Luleå Tekniska Universitet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2023