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

NCT05109741 | Completed

• 1 other identifier: KIELSA1
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Psychotherapy; Psychodynamic therapy; Behavioral activation; Internet

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• General Anxiety Questionnaire-7 (GAD-7)

  Baseline

• General Anxiety Questionnaire-7 (GAD-7)

  Post-treatment (10 weeks)

• General Anxiety Questionnaire-7 (GAD-7)

  6-month follow-up

• General Anxiety Questionnaire-7 (GAD-7)

  12-month follow-up

• Brunnsviken Brief Quality of life scale (BBQ)

  Baseline

Study Arms (3)

Internet-based Psychodynamic Therapy

EXPERIMENTAL

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 Behavioral Activation

ACTIVE COMPARATOR

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

Waiting-list

NO INTERVENTION

Participants will be in a 10-week waiting period.

Interventions

Internet-based Psychodynamic Therapy BEHAVIORAL

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

Internet-based Psychodynamic Therapy

Internet-based Behavioral Activation BEHAVIORAL

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

Internet-based Behavioral Activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Robert Johansson, PhD

  Stockholm University and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 5, 2021
• Study Start: October 4, 2021
• Primary Completion: December 15, 2021
• Study Completion: May 15, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)