Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Nonsuicidal Self Injury; Adolescent - Emotional Problem; Adolescent Problem Behavior; Self-Criticism
• Intervention / Treatment: Behavioral: Treating self-criticism

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Region Östergötland BUP-kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient at the child- and adolescent psychiatric clinic in Linköping, Sweden.
• 15 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)
• the treatment is transdiagnostic so all diagnoses are included (See exclusion criteria for exceptions).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: Treating self-criticism; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of depression	Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S; Montgomery et al., 1979).	Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Symptoms of anxiety	Liebowitz Social Anxiety Scale, self-report (LSAS; Liebowitz, 1987)	Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Nonsuicidal self-injury	Selected items from Self-Injurious Thoughts and Behaviors interview (SITBI; Nock et al., 2007), Deliberate self-harm inventory (DSHI; Gratz et al., 2001) och Clinician Administered Nonsuicidal self-injury Disorder Interview (CANDI; Gratz et al., 2015)	Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Individually chosen behavior	A behavior driven by self-criticism	Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Self-Compassion	Self-Compassion Scale, short form (SCS; Raes et al., 2011)	Change from before to after intervention, and at 3- and 6- month follow-up
Psychological flexibility	Avoidance and Fusion Questionnaire for Youth (AFQ-Y8; Greco et al., 2008).	Change from before to after intervention, and at 3- and 6- month follow-up
Quality of life and functioning	The Work and Social Adjustment Scale, youth version (WSAS-Y; Mundt et al., 2002).	Change from before to after intervention, and at 3- and 6- month follow-up

Collaborators and Investigators

• Sponsor: Region Östergötland
• Investigators: Principal Investigator: Maria Zetterqvist, PhD, Region Östergötland and Linköping university

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: adolescents; self-criticism; group intervention; single-case experimental design
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Depression; Self-Injurious Behavior
• Other Study ID Numbers: 2021-04939

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No