Anxiety Clinical Trial
Official title:
Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
Verified date | July 2023 |
Source | Region Östergötland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Ostergotland BUP-kliniken | Linköping |
Lead Sponsor | Collaborator |
---|---|
Region Östergötland |
Sweden,
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 |
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