NCT05247190

Brief Summary

In this pilot study, the effect of a group intervention targeting self-criticism in adolescents in a clinical child- and adolescent psychiatric outpatient setting will be examined using a single-case experimental design (AB). Participants will be randomized to multiple baseline with weekly measures. Our primary outcomes, measured weekly, are self-criticism, nonsuicidal self-injury and symptoms of depression and anxiety, as well as an individually chosen behavior driven by self-criticism. Secondary outcomes are self-compassion, psychological flexibility, quality of life and functioning. In addition to the weekly administered questionnaires, before and after measures, and 3- and 6-month follow-up will be collected. After the treatment, participants will also be interviewed about their experiences of targeting self-criticism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.6 years

First QC Date

January 27, 2022

Last Update Submit

October 25, 2024

Conditions

Keywords

self-criticismadolescentsgroup interventionsingle-case experimental design

Outcome Measures

Primary Outcomes (1)

  • Self-criticism

    Forms of Self-Criticism and Self-Reassuring Scale (FSCRS; Gilbert et al., 2004)

    Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

Secondary Outcomes (7)

  • Self-Compassion

    Change from before to after intervention, and at 3- and 6- month follow-up

  • Psychological flexibility

    Change from before to after intervention, and at 3- and 6- month follow-up

  • Quality of life and functioning

    Change from before to after intervention, and at 3- and 6- month follow-up

  • Symptoms of depression

    Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

  • Symptoms of anxiety

    Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

  • +2 more secondary outcomes

Study Arms (1)

Treating self-criticism

EXPERIMENTAL

8-session group intervention targeting self-criticism given 2-hrs/week with booster session after 3-months.

Behavioral: Treating self-criticism

Interventions

A psychological treatment given i a group format targeting self-criticism. The treatment is based on treatment principles from Cognitive behavior therapy, Self-compassion, Acceptance and Commitment Therapy and also contains psychoeducation. The group treatment consists of 8 sessions delivered once a week for 2 hrs during 8 weeks in a child- and adolescent psychiatric outpatient setting.

Treating self-criticism

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient at the child- and adolescent psychiatric clinic in Linköping, Sweden.
  • to 18 years
  • an adequate understanding of the Swedish language
  • cognitively capable of giving informed consent
  • scoring 26 or above on subscale "Inadequate self" and 8.5 or above on subscale "Hated Self" on questionnaire Forms of Self-Criticism and Self-Reassuring Scale (FSCRS)

You may not qualify if:

  • severe anorexia, BMI ≤ 16
  • ongoing substance abuse
  • diagnosed intellectual disability
  • needing interpreter for translation of Swedish language
  • participants who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Ostergotland BUP-kliniken

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Self-Injurious BehaviorDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Maria Zetterqvist, PhD

    Region Östergötland and Linköping university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-case experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass professor

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 18, 2022

Study Start

December 3, 2021

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations