- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603235
Manual-based Art Therapy for Adolescents With Depression
Manual-based Art Therapy for Adolescents With Depression: a Pilot Study in Child and Youth Psychiatric Clinic in Sweden
There is a need to evaluate different interventions in order to meet young people's needs of treatment. The study's goal is to find out if manual-based art therapy is a useful method for young people with depression and thus increase the availability of methods of treatment for adolescents with depression in Child and youth psychiatry in Sweden.
The aim is to investigate whether manual-based art therapy is useful as treatment for adolescents with depression by examining feasibility, acceptability and compliant to treatment. Secondary, preliminary study of adolescent depressive symptoms, quality of life and functional level is affected by the treatment.
Method: Data from youths aged 13-17 years old and their parents will be collected with questionnaires and structured interviews. Measurements are taken before and after treatment. Acceptability and feasibility will be examined by participants' presence, drop out and cancellations and also by checking the art therapists' compliance to the manual and investigate their reasons to diverge from the manual
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Västra Götaland
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Borås, Västra Götaland, Sweden, 50182
- Sodra Alvsborgs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 13-17 year
- Depression as main diagnosis
Exclusion Criteria:
- high suicide risk
- ongoing psychosis
- eating disorder
- Untreated PTSD
- Patients are excluded if there is suspicion of violence, abuse, abuse in the home or other vulnerability which requires other interventions to ensure the safety.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
This is a quasi-experimental study
|
This is a manual-based treatment and consists of 10 one-hour weekly sessions.
The treatment consist of detailed guidelines based on phenomenological art therapy.
The sessions follow the same structure: Introduction, short relaxation, art-making, reflections about the image, and conclusions.
Examples of comprised art tasks; lifeline, emotional scribbles, and different roles.
The art tasks served as a prompt for painting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to manual - therapists
Time Frame: 10 weeks
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the therapists self-rate their compliance to the manual on a 4 point Likert scale.
describing reasons to adverting from manual
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10 weeks
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Change of Treatment satisfaction
Time Frame: Change from baseline at 10 weeks
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Level of satisfactions rated on a 5 point Likert scale.
Higher scores indicates higher satisfaction.
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Change from baseline at 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Depression with Beck Depression Inventory BDI-II
Time Frame: Change from baseline at 10 weeks
|
contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher score indicate more severe depression.
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Change from baseline at 10 weeks
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Change of quality of life measured with KIDSCREEN-10
Time Frame: Change from baseline at 10 weeks
|
Measure global Health related quality of life.
HRQoL score for monitoring and screening uses.
the questionnaire consist of 10 questions, each answer being scored on a 5 points Likert scale.
|
Change from baseline at 10 weeks
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Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P
Time Frame: Change from baseline at 10 weeks
|
Is a self-reported scale to measure functional impairment attributed to an identified problem. is a five-item self-report scale measuring functional impairment on a nine-point scale.
Higher rating indicating more impairment.
|
Change from baseline at 10 weeks
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Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS
Time Frame: Change from baseline at 10 weeks
|
47-item questionnaires that measure the reported frequency of various symptoms of anxiety and low mood.
They produce a total anxiety and low mood score and separate scores for each of the follow sub-scales: separation anxiety; social phobia; generalized anxiety; panic; obsessive compulsive; total anxiety; and, low mood.
Each answer being scored on a 4 points Likert scale.
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Change from baseline at 10 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina Blomdahl, PhD, Region Vastra Gotaland, Sweden
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 254011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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