NCT05887141

Brief Summary

The purpose of this study is to investigate two independent Virtual Reality interventions for self-criticism and self-compassion and the use of perspective-change in these interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2023

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

May 1, 2023

Last Update Submit

July 15, 2024

Conditions

Keywords

Virtual Realityself-criticismself-compassionperspective changeCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

  • Self-Criticism and Self-Compassion Scales (SCCS) - Change in Self-Criticism

    Levels of state self-criticism as measured by the SCCS. The questionnaire consists of five scenarios that could induce self-critical and/or self-compassionate reactions. For the self-criticism scale, participants indicate on a 7-point Likert scale (1= not at all to 7= highly) to what extent they would react towards themselves in a contemptuous, critical, and harsh manner (range 15-105, higher scores reflect more self-criticism).

    Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention

  • Self-Criticism and Self-Compassion Scales (SCCS) - Change in Self-Compassion

    Levels of state self-compassion as measured by the SCCS. The questionnaire consists of five scenarios that could induce self-critical and/or self-compassionate reactions. For the self-compassion scale, participants indicate on a 7-point Likert scale (1= not at all to 7= highly) to what extent they would react towards themselves in a reassuring, soothing, and compassionate manner (range 15-105, higher scores reflect more self-compassion).

    Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention

Secondary Outcomes (3)

  • Change in negative affect

    Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention

  • Change in positive affect

    Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention

  • Change in self-compassion and self-esteem

    Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention

Other Outcomes (6)

  • Demographics

    Screening

  • Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS)

    Screening

  • Evaluation questions

    Directly after the +/- 60 minute intervention (Timepoint 2)

  • +3 more other outcomes

Study Arms (2)

Control Condition (no perspective change)

OTHER

The intervention (two role-plays), however without using a perspective change afterwards.

Behavioral: Double StandardsBehavioral: Self-criticism avatar

Perspective change condition

EXPERIMENTAL

The intervention (two role-plays) with a perspective change after each role-play.

Behavioral: Double StandardsBehavioral: Self-criticism avatar

Interventions

We created a VR intervention based on the Cognitive Behavioral Therapy (CBT) technique 'double standards'. In the intervention the participants have to respond to a virtual character they imagine as their friend, who expresses similar self-criticism as they struggle with themselves. Two role-plays are played in Virtual Reality (either with or without perspective change after the role-plays). In the perspective change condition, the perspective is changed with the virtual friend (second person perspective).

Control Condition (no perspective change)Perspective change condition

We created a VR intervention called 'Self-criticism avatar' that has common ground with two-chair dialogue. Participants have to assertively respond to their inner critic who criticizes them using their own self-critical thoughts. After responding assertively (for example: 'Go away, I don't need you', 'Good is good enough'), the virtual character becomes weaker until they give up. Two role-plays are played in Virtual Reality (either with or without perspective change after the role-plays). In the perspective change condition, the perspective is changed with a bystander (third person perspective).

Control Condition (no perspective change)Perspective change condition

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in a study
  • Score above 20 (\>20) on the subscale 'Inadequate self' of the FSCRS questionnaire

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Hidding M, Veling W, Pijnenborg GHM, van der Stouwe ECD. Facing your inner critic: a randomized controlled trial investigating a virtual reality intervention with and without a perspective change for excessive self-criticism. J Behav Ther Exp Psychiatry. 2025 Dec;89:102053. doi: 10.1016/j.jbtep.2025.102053. Epub 2025 Jul 16.

Study Officials

  • Elise van der Stouwe

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two independent substudies, each with two arms. N=68 per substudy (N=136 total)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

June 2, 2023

Study Start

October 12, 2021

Primary Completion

June 9, 2023

Study Completion

June 9, 2023

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from Marit Hidding, upon reasonable request.

Locations