VirtuS: Self-compassion and Self-criticism: a Virtual Reality Intervention

Sponsor

University Medical Center Groningen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05887141

Collaborator

PPO (Other), University of Groningen (Other)

136

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Self-Criticism	Behavioral: Double Standards Behavioral: Self-criticism avatar	N/A

Detailed Description

The current study will use two novel Virtual Reality (VR) exercises that will be investigated through two independent sub-studies. First of all, an exercise that uses the CBT (Cognitive Behavioral Therapy) technique called 'Double standards'. People with excessive self-criticism often set higher standards for themselves, which makes them more critical towards themselves. A way to distance from this, to enable a more nuanced reflection, is to ask the patient what they would say to a friend having those same negative thoughts about themselves. Doing this utilizing a role play in a realistic VR environment of which the avatar has the characteristics of a friend, the effect could be even stronger. Furthermore, VR offers the chance to switch perspectives, in which the participants receive their own compassionate comments from the perspective of the friend, and experience themselves as a good friend.

The second exercise, 'Self-criticism avatar', has common grounds with the (two-)chair exercises of schema therapy and the voice dialogue method in which a patient enters a dialogue between one's inner voices. In the VR exercise, the participant will be able to choose a virtual character with a voice that represents their own inner critic and that gives them their own self-criticism. By assertively and strictly speaking up to the inner critic, after which the virtual character becomes smaller and smaller until it backs down, the participant can experience a sense of control over their self-criticism, which leaves more room for self-compassion. A discussion with the inner critic enables a more nuanced image with more self-compassion. The switch in perspective after the role-play allows the participant to see himself/herself speaking assertively to the avatar, which can strengthen the increase in self-compassion and decrease in self-criticism.

Switching of perspectives is a relatively new technique within VR, that can be of added value to regular psychological therapies. Regular psychological therapies use switching of perspectives by switching roles in a physical role-play between a therapist and a patient or in a group. Furthermore, imaginative switches of perspective are used in, for example, schema therapy or imagery rescripting. Even though this can bring new insight into another perspective, it is not possible to replay the role play where the participant can see himself/herself from someone else's perspective. This is, however, possible through VR.

The current study will investigate the two beforementioned VR exercises using two independent sub-studies, to determine whether they contribute to self-compassion and if the switch in perspective is of added value. This will be done by comparing two conditions for each VR exercise; one with a switch in perspective and one without a switch in perspective. The study aims to answer the following research questions:

Do the two VR-self compassion exercises have a positive effect on self-compassion (increase) and self-criticism (decrease)?
Is the switch in perspective for the exercise 'Double standards of added value? In other words: is receiving one's own compassionate response of added value in addition to showing compassion to a vulnerable other.
Is the switch in perspective for the exercise 'self-criticism avatar' of added value? In other words: is watching oneself in a strong and resilient manner of added value in addition to assertively speaking up to one's inner critic?

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Self-compassion and Self-criticism: a Virtual Reality Intervention

Actual Study Start Date :

Oct 12, 2021

Anticipated Primary Completion Date :

Jun 9, 2023

Anticipated Study Completion Date :

Jun 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Condition (no perspective change) The intervention (two role-plays), however without using a perspective change afterwards.	Behavioral: Double Standards 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). Behavioral: Self-criticism avatar 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).
Experimental: Perspective change condition The intervention (two role-plays) with a perspective change after each role-play.	Behavioral: Double Standards 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). Behavioral: Self-criticism avatar 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).

Arm

Intervention/Treatment

Other: Control Condition (no perspective change)

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

Behavioral: Double Standards

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).

Behavioral: Self-criticism avatar

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).

Experimental: Perspective change condition

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

Behavioral: Double Standards

Behavioral: Self-criticism avatar

Outcome Measures

Primary Outcome Measures

Self-Criticism and Self-Compassion Scales (SCCS) - Change in Self-Criticism [Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention]
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).
Self-Criticism and Self-Compassion Scales (SCCS) - Change in Self-Compassion [Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention]
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).

Secondary Outcome Measures

Change in negative affect [Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention]
Visual Analogue Scales (VAS) measuring negative affect with three questions (range 0-100 for each question, higher scores reflect a higher negative affect)
Change in positive affect [Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention]
Visual Analogue Scales (VAS) measuring positive affect with three questions (range 0-100 for each questions, higher scores reflect a higher positive affect)
Change in self-compassion and self-esteem [Right before (Timepoint 1) and directly after (Timepoint 2) the +/- 60 minute intervention]
Visual Analogue Scales (VAS) measuring self-compassion and self-esteem with six questions (range 0-100 for each question, higher scores reflect higher self-compassion and self-esteem)

Other Outcome Measures

Demographics [Screening]
Age, gender and whether they've received psychological treatment in past/present
Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS) [Screening]
Trait levels of self-compassion and self-criticism as measured by the FSCRS. This questionnaire consists of 22 questions divided over 3 scales: 'Inadequate Self scale' (range 0-36, where higher scores reflect more self-criticism), 'Hated self' (range 0-20, where higher scores reflect more excessive self-criticism) and 'Reassured Self' (range 0-32, where higher scores reflect more self-compassion). Each question is answered on a 5-point Likert Scale (0= not at all like me; 4= extremely like me).
Evaluation questions [Directly after the +/- 60 minute intervention (Timepoint 2)]
A questionnaire asking participants what they thought of the intervention, consisting of nine questions answered on a 7-point Likert scale (with 1= strongly disagree and 7= strongly agree).
Igroup Presence questionnaire (IPQ) [Directly after the +/- 60 minute intervention (Timepoint 2)]
A questionnaire measuring presence in VR. The IPQ consists of 14 items that measure 3 subscales ('Spatial Presence', 'Involvement' and 'Experienced Realism') and has 1 item that measures the general 'sense of being there'. Participants answer the questions on a 7-point Likert scale ranging from -3 to +3.
Schema Mode Inventory, short version (SMI) [Right before the +/- 60 minute intervention (Timepoint 1)]
A questionnaire measuring the presence of 14 different schema modes (based on schema therapy). The questionnaire consists of 118 questions which participants answer on a 6 point Likert-scale (1= never/rarely, 6= always).
Suicide Probability Scale - Suicide Ideation [Right before the +/- 60 minute intervention (Timepoint 1)]
A questionnaire that measures the probability of suicide. For our study, we only included questions that measure the Suicide Ideation scale of the questionnaire. This scale consists of 8 questions that are answered on a 4-point Likert scale (0=Never/rarely to 3= Almost always/always). The range for the subscale Suicide Ideation is 0-24, where higher scores reflect more suicide ideation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

University Medical Center Groningen
PPO
University of Groningen

Investigators

Principal Investigator: Elise van der Stouwe, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05887141

Other Study ID Numbers:

10036

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 6, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Medical Center Groningen

Cognitive Behavioral Therapy

Study Results

No Results Posted as of Jun 6, 2023