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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05247190
Other study ID # 2021-04939
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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