Clinical trial NCT05247190: Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
Official title: Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent - Emotional Problem
Adolescent Problem Behavior
Nonsuicidal Self Injury
Depressive Symptoms
Anxiety
Self-Criticism
Keywords: self-criticism
adolescents
group intervention
single-case experimental design
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 19
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-case experimental design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-criticism
timeFrame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Secondary outcomes:
measure: Self-Compassion
timeFrame: Change from before to after intervention, and at 3- and 6- month follow-up
measure: Psychological flexibility
timeFrame: Change from before to after intervention, and at 3- and 6- month follow-up
measure: Quality of life and functioning
timeFrame: Change from before to after intervention, and at 3- and 6- month follow-up
measure: Symptoms of depression
timeFrame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
measure: Symptoms of anxiety
timeFrame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
measure: Nonsuicidal self-injury
timeFrame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
measure: Individually chosen behavior
timeFrame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Region Ostergotland BUP-kliniken
Study officials:
affiliation: Region Östergötland and Linköping university
name: Maria Zetterqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: