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

NCT ID: NCT06665321

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-06-30

Brief Summary

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.

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.

Conditions

Trait Neuroticism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based psychodynamic therapy

The treatment consist of a 9 week long IPDT intervention based on Affect Phobia Therapy with weekly therapist support.

Group Type: EXPERIMENTAL

Internet-based psychodynamic therapy (IPDT)

Intervention Type: BEHAVIORAL

The intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.

Wait-list control condition

Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gerhard Andersson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Department of Behavioral Sciences and Learning

Linköping, Östergörland, Sweden

Countries

Sweden

Central Contacts

Gerhard Andersson, PhD

Role: CONTACT

gerhard.andersson@liu.se

+46-13285840

Tomas Lindegaard, PhD

Role: CONTACT

tomas.lindegaard@liu.se

Facility Contacts

Gerhard Andersson, PhD

Role: primary

gerhard.andersson@liu.se

+46-13285840

Other Identifiers

LINNEA

Identifier Type: -

Identifier Source: org_study_id