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

Depression Clinical Trial

— ELSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109741
• Other study ID #: KIELSA1
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 15, 2023
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Internet-based Psychodynamic Therapy
Internet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg
• Internet-based Behavioral Activation
Internet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	Baseline
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	Post-treatment (10 weeks)
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	6-month follow-up
Primary	Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	12-month follow-up
Secondary	General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	Baseline
Secondary	General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	Post-treatment (10 weeks)
Secondary	General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	6-month follow-up
Secondary	General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	12-month follow-up
Secondary	Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	Baseline
Secondary	Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	Post-treatment (10 weeks)
Secondary	Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	6-month follow-up
Secondary	Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	12-month follow-up