Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT05109741
• Lead Sponsor: Karolinska Institutet

Brief Summary

There are several treatment options for depression, including Internet-delivered psychotherapy. While a majority of this research is based on cognitive behavior therapy (ICBT), there are also several recent studies investigating Internet-delivered psychodynamic therapy (IPDT). Importantly though, these treatments have never been directly compared in a randomized controlled trial.

In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.

Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.

In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.

Detailed Description

Depression is a widespread problem in Sweden and the world. The condition causes great suffering for the affected individual and his or her family, and involves major costs for society. There is promising support for psychological treatment of depression in the form of cognitive behavioural therapy and psychodynamic therapy, among others, also as self-help treatment in an internet-based format.

Internet psychodynamic therapy (IPDT) has shown significant effects in the treatment of both depression and anxiety disorders, but also in the treatment of somatic problems. The effects also appear to have improved from end of treatment to follow-up in most studies, with subjects largely completing the full treatment programme. In conclusion, the results for this form of treatment are very promising.

However, internet-based psychodynamic therapy for depression has never been compared with Internet-based CBT (ICBT) in a randomised controlled trial. This is not only an important issue from the perspective of comparing efficacy. Such a comparative study could also provide a basis for gathering information on predictors of treatment response. Based on the psychotherapy literature, there is reason to believe that different patients respond to different treatments. Thus, a comparative study between ICBT and IPDT may also provide a basis for answering the question "Which works for whom?".

In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.

Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.

In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-05
• Primary Completion: 2021-12-15
• Study Completion: 2023-05-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Age over 18 years
• A total score ≥10 on the PHQ-9

Exclusion Criteria

• A score of >1 on the PHQ-9 item 9
• A total score >20 on the PHQ-9
• A psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
• Alcohol or substance addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	12-month follow-up	Self-report measure of symptoms of depression

Secondary Outcome Measures

Name	Time	Method
Brunnsviken Brief Quality of life scale (BBQ)	12-month follow-up	Self-report measure of quality of life
General Anxiety Questionnaire-7 (GAD-7)	12-month follow-up	Self-report measure of symptoms of anxiety

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden