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

October 29, 2024 updated by: Gerhard Andersson, Linkoeping University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Östergörland
      • Linköping, Östergörland, Sweden, 58183
        • Department of Behavioral Sciences and Learning
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eysenck Personality Questionnaire Revised - Shortform (EPQR-S)
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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
Time Frame: 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.
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
Time Frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
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
Time Frame: Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerhard Andersson, PhD, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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