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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247190
• Other study ID #: 2021-04939
• Status: Completed
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: June 27, 2023

Study information

• Verified date: July 2023
• Source: Region Östergötland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent - Emotional Problem
• Adolescent Problem Behavior
• Anxiety
• Depression
• Depressive Symptoms
• Nonsuicidal Self Injury
• Problem Behavior
• Self-Criticism
• Self-Injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
Sweden	Region Ostergotland BUP-kliniken	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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