Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- Luleå Tekniska Universitet
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Mindfulness post-treatment
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
John Näsling
Lic. psychologist / Doctoral student
Luleå Tekniska Universitet
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
Outcomes
Primary Outcomes
Mindfulness post-treatment
Time Frame: 3 weeks post-treatment
Measured using FFMQ, mindfulness
Alexithymia post-treatment
Time Frame: 3 weeks post-treatment
Measured using TAS-20, mindfulness
Generalization
Time Frame: 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.
Anxiety, Depression and Stress symptoms post-treatment
Time Frame: 3 weeks post-treatment
Measured using DASS-21
Anxiety sensitivity post-treatment
Time Frame: 3 weeks post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Experiential avoidance post-treatment
Time Frame: 3 weeks post-treatment
Measured using AFQ-Y8, psychological flexibility
Experiential avoidance follow-up
Time Frame: 6 months post-treatment
Measured using AFQ-Y8, psychological flexibility
Alexithymia follow-up
Time Frame: 6 months post-treatment
Measured using TAS-20, mindfulness
Anxiety, Depression and Stress symptoms follow-up
Time Frame: 6 months post-treatment
Measured using DASS-21
Mindfulness follow-up
Time Frame: 6 months post-treatment
Measured using FFMQ, mindfulness
Anxiety sensitivity follow-up
Time Frame: 6 months post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Secondary Outcomes
- Additional treatment(6 months post-treatment)