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Completed

NCT Number: NCT05247190

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.

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Key information

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Ostergotland BUP-kliniken

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treating self-criticism

Behavioral

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.

Primary outcomes

  1. Self-criticism

    Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

    Forms of Self-Criticism and Self-Reassuring Scale (FSCRS; Gilbert et al., 2004)

Secondary outcomes

  1. Self-Compassion

    Time frame: Change from before to after intervention, and at 3- and 6- month follow-up

    Self-Compassion Scale, short form (SCS; Raes et al., 2011)

  2. Psychological flexibility

    Time frame: Change from before to after intervention, and at 3- and 6- month follow-up

    Avoidance and Fusion Questionnaire for Youth (AFQ-Y8; Greco et al., 2008).

  3. Quality of life and functioning

    Time frame: Change from before to after intervention, and at 3- and 6- month follow-up

    The Work and Social Adjustment Scale, youth version (WSAS-Y; Mundt et al., 2002).

  4. Symptoms of depression

    Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

    Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S; Montgomery et al., 1979).

  5. Symptoms of anxiety

    Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

    Liebowitz Social Anxiety Scale, self-report (LSAS; Liebowitz, 1987)

  6. Nonsuicidal self-injury

    Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

    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)

  7. Individually chosen behavior

    Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months

    A behavior driven by self-criticism

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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