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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Internet-based Psychodynamic Therapy; Behavioral: Internet-based Behavioral Activation

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 Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based Psychodynamic Therapy; This is a 10-week treatment based on the psychodynamic SUBGAP model ("Seeing, Understanding, Breaking, and Guarding Against Patterns") by Farrell Silverberg (2005). The treatment has been evaluated in two previous randomized controlled trials. Silverberg, F. (2005). Make the leap: A practical guide to breaking the patterns that hold you back. Da Capo Press. Andersson, G., Paxling, B., Roch-Norlund, P., Östman, G., Norgren, A., Almlöv, J., ... & Silverberg, F. (2012). Internet-based psychodynamic versus cognitive behavioral guided self-help for generalized anxiety disorder: a randomized controlled trial. Psychotherapy and psychosomatics, 81(6), 344-355. Johansson, R., Ekbladh, S., Hebert, A., Lindström, M., Möller, S., Petitt, E., ... & Andersson, G. (2012). Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PloS one, 7(5), e38021.	Behavioral: Internet-based Psychodynamic Therapy; Internet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg
Active Comparator: Internet-based Behavioral Activation; This 10-week treatment is based on the BATD-R ("Behavioral Activation Treatment for Depression - Revised") treatment by Lejuez and others (2011). Lejuez, C. W., Hopko, D. R., Acierno, R., Daughters, S. B., & Pagoto, S. L. (2011). Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behavior modification, 35(2), 111-161.	Behavioral: Internet-based Behavioral Activation; Internet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others.
No Intervention: Waiting-list; Participants will be in a 10-week waiting period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	Baseline
Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	Post-treatment (10 weeks)
Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	6-month follow-up
Patient Health Questionnaire-9 (PHQ-9)	Self-report measure of symptoms of depression	12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	Baseline
General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	Post-treatment (10 weeks)
General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	6-month follow-up
General Anxiety Questionnaire-7 (GAD-7)	Self-report measure of symptoms of anxiety	12-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	Baseline
Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	Post-treatment (10 weeks)
Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	6-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)	Self-report measure of quality of life	12-month follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm University
• Investigators: Principal Investigator: Robert Johansson, PhD, Stockholm University and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Psychodynamic therapy; Psychotherapy; Internet; Behavioral activation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: KIELSA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No