Skip to main content
OpenTrials
Completed

NCT Number: NCT05109741

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based Psychodynamic Therapy

Behavioral

Internet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg

Internet-based Behavioral Activation

Behavioral

Internet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others.

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline

    Self-report measure of symptoms of depression

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Post-treatment (10 weeks)

    Self-report measure of symptoms of depression

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 6-month follow-up

    Self-report measure of symptoms of depression

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 12-month follow-up

    Self-report measure of symptoms of depression

Secondary outcomes

  1. General Anxiety Questionnaire-7 (GAD-7)

    Time frame: Baseline

    Self-report measure of symptoms of anxiety

  2. General Anxiety Questionnaire-7 (GAD-7)

    Time frame: Post-treatment (10 weeks)

    Self-report measure of symptoms of anxiety

  3. General Anxiety Questionnaire-7 (GAD-7)

    Time frame: 6-month follow-up

    Self-report measure of symptoms of anxiety

  4. General Anxiety Questionnaire-7 (GAD-7)

    Time frame: 12-month follow-up

    Self-report measure of symptoms of anxiety

  5. Brunnsviken Brief Quality of life scale (BBQ)

    Time frame: Baseline

    Self-report measure of quality of life

  6. Brunnsviken Brief Quality of life scale (BBQ)

    Time frame: Post-treatment (10 weeks)

    Self-report measure of quality of life

  7. Brunnsviken Brief Quality of life scale (BBQ)

    Time frame: 6-month follow-up

    Self-report measure of quality of life

  8. Brunnsviken Brief Quality of life scale (BBQ)

    Time frame: 12-month follow-up

    Self-report measure of quality of life

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm University

Registry information

Acronym: ELSA

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Nov 5, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.