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

Primary Purpose

Anxiety Disorders, Depression

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Treatment condition: Internet-administered Unified protocol
Treatment condition: Internet-administered Affect phobia treatment
Treatment condition: Waitlist control
Treatment length: 8 weeks
Treatment length: 16 weeks
Access to a moderated forum
No access to a moderated forum
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

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

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).

Sites / Locations

  • Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CBT, 8 weeks and access to forum.

CBT, 16 weeks and access to forum.

CBT, 8 weeks and no access to forum.

CBT, 16 weeks and no access to forum.

Psychodynamic therapy, 8 weeks and access to forum.

Psychodynamic therapy, 16 weeks and access to forum.

Psychodynamic therapy, 8 weeks and no access to forum.

Psychodynamic therapy, 16 weeks and no access to forum.

Waitlist, 8 weeks and access to forum.

Waitlist, 16 weeks and access to forum.

Waitlist, 8 weeks and no access to forum.

Waitlist, 16 weeks and no access to forum.

Arm Description

Outcomes

Primary Outcome Measures

Patient Health Questionnaire 9-item scale (PHQ-9)
The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Generalised Anxiety Disorder 7- item scale (GAD-7)
The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Brunnsviken Brief Quality of Life Scale (BBQ)
The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Secondary Outcome Measures

The Personality Inventory for DSM Short Form (PID-5)
The PID-5 is a self-rated measure of personality-related problems featuring 25 items.
Negative Effects Questionnaire (NEQ)
The NEQ measures unwanted effects of treatments.
Reflective Functioning Questionnaire 8 (RFQ-8)
RFQ features 8 items assessing the ability to understand mental states of the self and others.

Full Information

First Posted
August 8, 2021
Last Updated
January 12, 2023
Sponsor
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT05016843
Brief Title
The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression
Acronym
TRAbee
Official Title
The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm University

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT, 8 weeks and access to forum.
Arm Type
Experimental
Arm Title
CBT, 16 weeks and access to forum.
Arm Type
Experimental
Arm Title
CBT, 8 weeks and no access to forum.
Arm Type
Experimental
Arm Title
CBT, 16 weeks and no access to forum.
Arm Type
Experimental
Arm Title
Psychodynamic therapy, 8 weeks and access to forum.
Arm Type
Experimental
Arm Title
Psychodynamic therapy, 16 weeks and access to forum.
Arm Type
Experimental
Arm Title
Psychodynamic therapy, 8 weeks and no access to forum.
Arm Type
Experimental
Arm Title
Psychodynamic therapy, 16 weeks and no access to forum.
Arm Type
Experimental
Arm Title
Waitlist, 8 weeks and access to forum.
Arm Type
Experimental
Arm Title
Waitlist, 16 weeks and access to forum.
Arm Type
Experimental
Arm Title
Waitlist, 8 weeks and no access to forum.
Arm Type
Experimental
Arm Title
Waitlist, 16 weeks and no access to forum.
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Treatment condition: Internet-administered Unified protocol
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment condition: Internet-administered Affect phobia treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment condition: Waitlist control
Intervention Description
The waitlist condition is a control condition without any intervention.
Intervention Type
Other
Intervention Name(s)
Treatment length: 8 weeks
Intervention Description
Participants will partake in their treatment condition for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Treatment length: 16 weeks
Intervention Description
Participants will partake in their treatment condition for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Access to a moderated forum
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No access to a moderated forum
Intervention Description
Participants will not have access to a moderated forum, hence their treatment is self-guided.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire 9-item scale (PHQ-9)
Description
The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Time Frame
Through study completion, an average of 2 years.
Title
Generalised Anxiety Disorder 7- item scale (GAD-7)
Description
The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Time Frame
Through study completion, an average of 2 years.
Title
Brunnsviken Brief Quality of Life Scale (BBQ)
Description
The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Time Frame
Through study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
The Personality Inventory for DSM Short Form (PID-5)
Description
The PID-5 is a self-rated measure of personality-related problems featuring 25 items.
Time Frame
Baseline only.
Title
Negative Effects Questionnaire (NEQ)
Description
The NEQ measures unwanted effects of treatments.
Time Frame
At post-treatment only (which is week 8 or 16 depending on treatment allocation).
Title
Reflective Functioning Questionnaire 8 (RFQ-8)
Description
RFQ features 8 items assessing the ability to understand mental states of the self and others.
Time Frame
Through study completion, an average of 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Department of Psychology
City
Stockholm
ZIP/Postal Code
10691
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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