The Study of Internet-delivered, Transdiagnostic Treatments for Anxiety and Depression ("TRAnsdiagnostisk BEhandling (Elektronisk)")
Overview
- Phase
- Not Applicable
- Intervention
- Treatment condition: Internet-administered Unified protocol
- Conditions
- Anxiety Disorders
- Sponsor
- Stockholm University
- Enrollment
- 2477
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire 9-item scale (PHQ-9)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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).
Investigators
Per Carlbring
Professor
Stockholm University
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).
Arms & Interventions
CBT, 8 weeks and access to forum.
Intervention: Treatment condition: Internet-administered Unified protocol
CBT, 8 weeks and access to forum.
Intervention: Treatment length: 8 weeks
CBT, 8 weeks and access to forum.
Intervention: Access to a moderated forum
CBT, 16 weeks and access to forum.
Intervention: Treatment condition: Internet-administered Unified protocol
CBT, 16 weeks and access to forum.
Intervention: Treatment length: 16 weeks
CBT, 16 weeks and access to forum.
Intervention: No access to a moderated forum
CBT, 8 weeks and no access to forum.
Intervention: Treatment condition: Internet-administered Unified protocol
CBT, 8 weeks and no access to forum.
Intervention: Treatment length: 8 weeks
CBT, 8 weeks and no access to forum.
Intervention: No access to a moderated forum
CBT, 16 weeks and no access to forum.
Intervention: Treatment condition: Internet-administered Unified protocol
CBT, 16 weeks and no access to forum.
Intervention: Treatment length: 16 weeks
CBT, 16 weeks and no access to forum.
Intervention: Access to a moderated forum
Psychodynamic therapy, 8 weeks and access to forum.
Intervention: Treatment condition: Internet-administered Affect phobia treatment
Psychodynamic therapy, 8 weeks and access to forum.
Intervention: Treatment length: 8 weeks
Psychodynamic therapy, 8 weeks and access to forum.
Intervention: Access to a moderated forum
Psychodynamic therapy, 16 weeks and no access to forum.
Intervention: Treatment condition: Internet-administered Affect phobia treatment
Psychodynamic therapy, 16 weeks and no access to forum.
Intervention: Treatment length: 16 weeks
Psychodynamic therapy, 16 weeks and no access to forum.
Intervention: No access to a moderated forum
Psychodynamic therapy, 16 weeks and access to forum.
Intervention: Treatment condition: Internet-administered Affect phobia treatment
Psychodynamic therapy, 16 weeks and access to forum.
Intervention: Treatment length: 16 weeks
Psychodynamic therapy, 16 weeks and access to forum.
Intervention: Access to a moderated forum
Psychodynamic therapy, 8 weeks and no access to forum.
Intervention: Treatment condition: Internet-administered Affect phobia treatment
Psychodynamic therapy, 8 weeks and no access to forum.
Intervention: Treatment length: 8 weeks
Psychodynamic therapy, 8 weeks and no access to forum.
Intervention: No access to a moderated forum
Waitlist, 8 weeks and access to forum.
Intervention: Treatment condition: Waitlist control
Waitlist, 8 weeks and access to forum.
Intervention: Treatment length: 8 weeks
Waitlist, 8 weeks and access to forum.
Intervention: Access to a moderated forum
Waitlist, 16 weeks and access to forum.
Intervention: Treatment condition: Waitlist control
Waitlist, 16 weeks and access to forum.
Intervention: Treatment length: 16 weeks
Waitlist, 16 weeks and access to forum.
Intervention: Access to a moderated forum
Waitlist, 8 weeks and no access to forum.
Intervention: Treatment condition: Waitlist control
Waitlist, 8 weeks and no access to forum.
Intervention: Treatment length: 8 weeks
Waitlist, 8 weeks and no access to forum.
Intervention: No access to a moderated forum
Waitlist, 16 weeks and no access to forum.
Intervention: Treatment condition: Waitlist control
Waitlist, 16 weeks and no access to forum.
Intervention: Treatment length: 16 weeks
Waitlist, 16 weeks and no access to forum.
Intervention: No access to a moderated forum
Outcomes
Primary Outcomes
Patient Health Questionnaire 9-item scale (PHQ-9)
Time Frame: 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.
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Through study completion, an average of 2 years.
The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Generalised Anxiety Disorder 7- item scale (GAD-7)
Time Frame: Through study completion, an average of 2 years.
The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Secondary Outcomes
- Negative Effects Questionnaire (NEQ)(At post-treatment only (which is week 8 or 16 depending on treatment allocation).)
- The Personality Inventory for DSM Short Form (PID-5)(Baseline only.)
- Reflective Functioning Questionnaire 8 (RFQ-8)(Through study completion, an average of 2 years.)