TRAbee: The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression

Sponsor
Stockholm University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05016843
Collaborator
(none)
2,400
Enrollment
1
Location
12
Arms
30.3
Anticipated Duration (Months)
79.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anxiety and depression are common psychiatric disorders, resulting in suffering and impaired functioning for the individual. Today, most psychological treatments are disorder specific, even tough comorbidity between depression and anxiety and different anxiety disorders is rule rather than exception. Transdiagnostic treatments target the common features between depression and anxiety disorders and has shown to be as effective as disorder specific treatments in reducing symptoms of the disorders. Unified protocol and Affect phobia treatment are two types of transdiagnostic treatments that, to our knowledge, never been compared in research before. Internet-administered treatment presents a promising way to increase availability of psychotherapeutic interventions such as transdiagnostic treatments. However, questions regarding the optimal treatment length and level of support remain unanswered. The aim of this study is to examine two internet-administered transdiagnostic treatments and their effect on anxiety and depression, and to investigate the impact of treatment length and access to a moderated forum.

The study will investigate three factors: type of transdiagnostic treatment, length of treatment and whether patients have access to a moderated forum or not. 2400 participants with anxiety and/or depression will be randomly assigned to one of 12 subgroups and subsequently offered treatment based on differing combinations of the previously mentioned factors (200 participants/arm). The treatment conditions are internet-administered cognitive, behavioral treatment (CBT) Unified protocol and the psychodynamic Affect phobia treatment as well as a waitlist control group. Participants will also be randomized to either 8 or 16 weeks of treatment and access to a moderated forum or not.

Primary outcome measures will be the Patient Health Questionnaire, the Generalized Anxiety Disorder 7-item scale and the Brief Quality of Life scale. Negative effects of treatment will also be assessed. In addition to pre- and post-treatment measurements, the study includes one mid-treatment and three follow-up assessments (6, 12 and 24 months).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Treatment condition: Internet-administered Unified protocol
  • Behavioral: Treatment condition: Internet-administered Affect phobia treatment
  • Other: Treatment condition: Waitlist control
  • Other: Treatment length: 8 weeks
  • Other: Treatment length: 16 weeks
  • Other: Access to a moderated forum
  • Other: No access to a moderated forum
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Mar 3, 2022
Anticipated Study Completion Date :
Mar 3, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: CBT, 8 weeks and access to forum.

Behavioral: Treatment condition: Internet-administered Unified protocol
Treatment condition: The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: CBT, 16 weeks and access to forum.

Behavioral: Treatment condition: Internet-administered Unified protocol
Treatment condition: The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Experimental: CBT, 8 weeks and no access to forum.

Behavioral: Treatment condition: Internet-administered Unified protocol
Treatment condition: The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Experimental: CBT, 16 weeks and no access to forum.

Behavioral: Treatment condition: Internet-administered Unified protocol
Treatment condition: The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: Psychodynamic therapy, 8 weeks and access to forum.

Behavioral: Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: Psychodynamic therapy, 16 weeks and access to forum.

Behavioral: Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: Psychodynamic therapy, 8 weeks and no access to forum.

Behavioral: Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Experimental: Psychodynamic therapy, 16 weeks and no access to forum.

Behavioral: Treatment condition: Internet-administered Affect phobia treatment
The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Experimental: Waitlist, 8 weeks and access to forum.

Other: Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: Waitlist, 16 weeks and access to forum.

Other: Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: Access to a moderated forum
During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.

Experimental: Waitlist, 8 weeks and no access to forum.

Other: Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.

Other: Treatment length: 8 weeks
Participants will partake in their treatment condition for 8 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Experimental: Waitlist, 16 weeks and no access to forum.

Other: Treatment condition: Waitlist control
The waitlist condition is a control condition without any intervention.

Other: Treatment length: 16 weeks
Participants will partake in their treatment condition for 16 weeks.

Other: No access to a moderated forum
Participants will not have access to a moderated forum, hence their treatment is self-guided.

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire 9-item scale (PHQ-9) [Through study completion, an average of 2 years.]

    The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

  2. Generalised Anxiety Disorder 7- item scale (GAD-7) [Through study completion, an average of 2 years.]

    The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  3. Brunnsviken Brief Quality of Life Scale (BBQ) [Through study completion, an average of 2 years.]

    The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Secondary Outcome Measures

  1. The Personality Inventory for DSM Short Form (PID-5) [Baseline only.]

    The PID-5 is a self-rated measure of personality-related problems featuring 25 items.

  2. Negative Effects Questionnaire (NEQ) [At post-treatment only (which is week 8 or 16 depending on treatment allocation).]

    The NEQ measures unwanted effects of treatments.

  3. Reflective Functioning Questionnaire 8 (RFQ-8) [Through study completion, an average of 2 years.]

    RFQ features 8 items assessing the ability to understand mental states of the self and others.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Be able to read and write Swedish,

  • access to a mobile phone/computer,

  • 18 years or older,

  • GAD-7 ≥ 5 and/or

  • PHQ-9 ≥ 10.

Exclusion Criteria:
  • Partaking in other psychological treatment,

  • has started or adjusted treatment with psychopharmacological drugs for anxiety, worry or depression within the nearest month,

  • severe depression (PHQ-9 ≥ 20) or suicidal (PHQ-9, item 9>2).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of PsychologyStockholmSweden10691

Sponsors and Collaborators

  • Stockholm University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Per Carlbring, Professor, Stockholm University
ClinicalTrials.gov Identifier:
NCT05016843
Other Study ID Numbers:
  • TRAbee
First Posted:
Aug 23, 2021
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021