Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial

The purpose of the study is to investigate if internet delivered affect-focused psychodynamic therapy (IPDT) leads to lowered levels of trait neuroticism compared to a wait-list control condition. The target group is adults (18+) who experience mild to moderate symptoms of anxiety and/or depression. The IPDT treatment consists of 8 modules that the participants will work with for 9 weeks, with therapist support. Participants will be recruited in Sweden with nationwide recruitment.

Study Overview

• Status: Not yet recruiting
• Conditions: Trait Neuroticism
• Intervention / Treatment: Behavioral: Internet-based psychodynamic therapy (IPDT)

Detailed Description

This study is a randomized controlled trial with the aim to investigate if IPDT leads to lowered levels of trait neuroticism. Participants will either be randomized to the treatment which is based on Affect Phobia Therapy or to a wait-list control. Participants will have weekly contact with a therapist who will provide feedback and support.

Primary outcome measure is trait neuroticism (measured on the 24-Item Neuroticism scale of the IPIP-NEO-120). Secondary outcome measures will include measures of anxiety, depression, quality of life, emotion regulation, and defense mechanism adaptiveness. Emotion regulation and short measure of anxiety and depressive symptoms will be collected weekly throughout the treatment period. Pre-treatment measurement, post-treatment measurement, weekly measure, and one-year follow up is planned to be collected through an online survey.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerhard Andersson, PhD; Phone Number: +46-13285840; Email: gerhard.andersson@liu.se
• Study Contact Backup: Name: Tomas Lindegaard, PhD; Email: tomas.lindegaard@liu.se

Study Locations

• Sweden
  • Östergörland
    • Linköping, Östergörland, Sweden, 58183
      • Department of Behavioral Sciences and Learning
      • Contact: Gerhard Andersson, PhD; Phone Number: +46-13285840; Email: gerhard.andersson@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Score 5 points or more on either the PHQ-9 or GAD-7
• 18 years or older
• Ability to speak, read and write in Swedish
• Have access to the internet and a smartphone, computer or other device

Exclusion Criteria:

• Severe psychiatric or somatic illness that makes participation difficult or impossible
• Ongoing addiction
• Acute suicidality
• Other ongoing psychological treatment
• Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based psychodynamic therapy; The treatment consist of a 9 week long IPDT intervention based on Affect Phobia Therapy with weekly therapist support.	Behavioral: Internet-based psychodynamic therapy (IPDT); The intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.
No Intervention: Wait-list control condition; Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation	Measure of trait neuroticism. Consists of 24 items. Each item is scored from 0-4 with a total range of 0-96. A higher score reflects a higher level of trait neuroticism.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eysenck Personality Questionnaire Revised - Shortform (EPQR-S)	12-item measure of trait neuroticism. Each item is score yes or no. Range 0-12 with a higher score indicating higher levels of neuroticism.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Patient Health Questionnaire-9	Measure depressive symptoms. Consist of nine items, scored from 0-3. A higher score indicates more depressive symptoms.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Generalized Anxiety Disorder-7	Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptoms.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of life scale	Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Difficulties in Emotion Regulation Scale-16	Measure of emotion regulation. Consists of 16 items scored from 1-5. A higher score indicates less adaptive emotion regulation.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination. Will be measured on a weekly basis during the 9 weeks of the intervention period.
Defense Mechanism Rating Scale - Self Report 30	Measures adaptiveness of defense mechanisms. Consists of 30 items scored from 0-4. A higher overall defense score (ODF) indicates more more adaptive defense mechanisms.	Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Patient Health Questionnaire - 4	Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.	Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Gerhard Andersson, PhD, Linkoeping University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Internet Intervention; Trait neuroticism; Internet-delivered psychodynamic therapy
• Other Study ID Numbers: LINNEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No