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

Primary Purpose

Adolescent - Emotional Problem, Adolescent Problem Behavior, Nonsuicidal Self Injury

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Treating self-criticism

About this trial

This is an interventional treatment trial for Adolescent - Emotional Problem focused on measuring self-criticism, adolescents, group intervention, single-case experimental design

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Region Ostergotland BUP-kliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treating self-criticism

Arm Description

8-session group intervention targeting self-criticism given 2-hrs/week with booster session after 3-months.

Outcomes

Primary Outcome Measures

Self-criticism

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

Symptoms of depression

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

Symptoms of anxiety

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

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)

Individually chosen behavior

A behavior driven by self-criticism

Secondary Outcome Measures

Self-Compassion

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

Psychological flexibility

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

Quality of life and functioning

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

Full Information

NCT ID

NCT05247190

First Posted

January 27, 2022

Last Updated

July 3, 2023

Sponsor

Region Östergötland

1. Study Identification

Unique Protocol Identification Number

NCT05247190

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 3, 2021 (Actual)

Primary Completion Date

June 27, 2023 (Actual)

Study Completion Date

June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adolescent - Emotional Problem, Adolescent Problem Behavior, Nonsuicidal Self Injury, Depressive Symptoms, Anxiety, Self-Criticism

Keywords

self-criticism, adolescents, group intervention, single-case experimental design

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-case experimental design

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treating self-criticism

Arm Type

Experimental

Arm Description

8-session group intervention targeting self-criticism given 2-hrs/week with booster session after 3-months.

Intervention Type

Behavioral

Intervention Name(s)

Treating self-criticism

Intervention Description

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 Outcome Measure Information:

Title

Self-criticism

Description

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

Time Frame