Adolescent - Emotional ProblemNCT05247190
Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
A study testing Treating self-criticism in people with Adolescent - Emotional Problem and Adolescent Problem Behavior, run by Region Östergötland at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Adolescent - Emotional Problem, Adolescent Problem Behavior, Nonsuicidal Self Injury
- What is being tested?
- Treating self-criticism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 3 Dec 2021to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- severe anorexia, BMI ≤ 16
- ongoing substance abuse
- diagnosed intellectual disability
- needing interpreter for translation of Swedish language
- participants who cannot give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Adolescent - Emotional Problem, Adolescent Problem Behavior, Nonsuicidal Self Injury, Depressive Symptoms, Anxiety, Self-Criticism
- Being tested
- Treating self-criticism
- Keywords
- self-criticism, adolescents, group intervention, single-case experimental design
- Medical subject headings
- Self-Injurious Behavior, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treating self-criticismBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treating self-criticism | Experimental | 8-session group intervention targeting self-criticism given 2-hrs/week with booster session after 3-months. Receives: Behavioral: Treating self-criticism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-criticism
Forms of Self-Criticism and Self-Reassuring Scale (FSCRS; Gilbert et al., 2004)
Measured: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Secondary outcomes (7)
Self-Compassion
Self-Compassion Scale, short form (SCS; Raes et al., 2011)
Measured: Change from before to after intervention, and at 3- and 6- month follow-up
Psychological flexibility
Avoidance and Fusion Questionnaire for Youth (AFQ-Y8; Greco et al., 2008).
Measured: Change from before to after intervention, and at 3- and 6- month follow-up
Quality of life and functioning
The Work and Social Adjustment Scale, youth version (WSAS-Y; Mundt et al., 2002).
Measured: Change from before to after intervention, and at 3- and 6- month follow-up
Symptoms of depression
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S; Montgomery et al., 1979).
Measured: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Symptoms of anxiety
Liebowitz Social Anxiety Scale, self-report (LSAS; Liebowitz, 1987)
Measured: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
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)
Measured: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Individually chosen behavior
A behavior driven by self-criticism
Measured: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start3 Dec 2021
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case experimental design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zetterqvist, Region Östergötland
- Investigators
- Maria Zetterqvist, PhD, Principal investigator, Region Östergötland and Linköping university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247190
- Sponsor's protocol ID
- 2021-04939
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Self-criticism in Adolescents: a Study With Single-case Experimental Design
- ClinicalTrials.gov ID
- NCT05247190
- Acronym / sponsor ID
- 2021-04939
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case experimental design
| Arm | Type | Receives |
|---|---|---|
| Treating self-criticism | Experimental | Behavioral: Treating self-criticism8-session group intervention targeting self-criticism given 2-hrs/week with booster session after 3-months. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- severe anorexia, BMI ≤ 16
- ongoing substance abuse
- diagnosed intellectual disability
- needing interpreter for translation of Swedish language
- participants who cannot give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treating self-criticismA 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. | Behavioural | Treating self-criticism |
Primary outcome
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)
7 secondary outcomes
Self-Compassion
Time frame: Change from before to after intervention, and at 3- and 6- month follow-up
Psychological flexibility
Time frame: Change from before to after intervention, and at 3- and 6- month follow-up
Quality of life and functioning
Time frame: Change from before to after intervention, and at 3- and 6- month follow-up
Symptoms of depression
Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Symptoms of anxiety
Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Nonsuicidal self-injury
Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Individually chosen behavior
Time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Zetterqvist, PhD principal investigator
Region Östergötland and Linköping university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treating self-criticism in people with Adolescent - Emotional Problem and Adolescent Problem Behavior, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-criticism (time frame: Change from baseline (phase A) at intervention (phase B) 8 weeks, and at 3- and 6- months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.