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Development of Transdiagnostic Single-session Treatment

Primary Purpose

Anxiety Disorders, Depression, Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transdiagnostic single-session treatment
Sponsored by
Luleå Tekniska Universitet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring transdiagnostic, single-session

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Treatment group

    Arm Description

    Transdiagnostic single-session treatment

    Outcomes

    Primary Outcome Measures

    Anxiety, Depression and Stress symptoms post-treatment
    Measured using DASS-21
    Anxiety, Depression and Stress symptoms follow-up
    Measured using DASS-21
    Anxiety sensitivity post-treatment
    Measured using BSQ, fear of bodily sensations related to anxiety
    Anxiety sensitivity follow-up
    Measured using BSQ, fear of bodily sensations related to anxiety
    Experiential avoidance post-treatment
    Measured using AFQ-Y8, psychological flexibility
    Experiential avoidance follow-up
    Measured using AFQ-Y8, psychological flexibility
    Mindfulness post-treatment
    Measured using FFMQ, mindfulness
    Mindfulness follow-up
    Measured using FFMQ, mindfulness
    Alexithymia post-treatment
    Measured using TAS-20, mindfulness
    Alexithymia follow-up
    Measured using TAS-20, mindfulness
    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    March 13, 2023
    Sponsor
    Luleå Tekniska Universitet
    Collaborators
    Region Norrbotten
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784259
    Brief Title
    Development of Transdiagnostic Single-session Treatment
    Official Title
    Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Luleå Tekniska Universitet
    Collaborators
    Region Norrbotten

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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?
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Depression, Stress Disorder
    Keywords
    transdiagnostic, single-session

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Transdiagnostic single-session treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Transdiagnostic single-session treatment
    Intervention Description
    Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation
    Primary Outcome Measure Information:
    Title
    Anxiety, Depression and Stress symptoms post-treatment
    Description
    Measured using DASS-21
    Time Frame
    3 weeks post-treatment
    Title
    Anxiety, Depression and Stress symptoms follow-up
    Description
    Measured using DASS-21
    Time Frame
    6 months post-treatment
    Title
    Anxiety sensitivity post-treatment
    Description
    Measured using BSQ, fear of bodily sensations related to anxiety
    Time Frame
    3 weeks post-treatment
    Title
    Anxiety sensitivity follow-up
    Description
    Measured using BSQ, fear of bodily sensations related to anxiety
    Time Frame
    6 months post-treatment
    Title
    Experiential avoidance post-treatment
    Description
    Measured using AFQ-Y8, psychological flexibility
    Time Frame
    3 weeks post-treatment
    Title
    Experiential avoidance follow-up
    Description
    Measured using AFQ-Y8, psychological flexibility
    Time Frame
    6 months post-treatment
    Title
    Mindfulness post-treatment
    Description
    Measured using FFMQ, mindfulness
    Time Frame
    3 weeks post-treatment
    Title
    Mindfulness follow-up
    Description
    Measured using FFMQ, mindfulness
    Time Frame
    6 months post-treatment
    Title
    Alexithymia post-treatment
    Description
    Measured using TAS-20, mindfulness
    Time Frame
    3 weeks post-treatment
    Title
    Alexithymia follow-up
    Description
    Measured using TAS-20, mindfulness
    Time Frame
    6 months post-treatment
    Title
    Generalization
    Description
    Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.
    Time Frame
    6 months post-treatment
    Secondary Outcome Measure Information:
    Title
    Additional treatment
    Description
    It will be recorded if patients sought additional care after single-session treatment as well as type of care.
    Time Frame
    6 months post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John Näsling, Master
    Phone
    +4673 080 77 67
    Email
    john.nasling@ltu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Näsling, Master
    Organizational Affiliation
    Luleå tekniska universitet/Region Norrbotten
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Development of Transdiagnostic Single-session Treatment

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