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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04603235
Other study ID # 254011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date October 8, 2020

Study information

Verified date October 2020
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 8, 2020
Est. primary completion date October 8, 2020
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Manual-based Art Therapy
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.

Locations

Country Name City State
Sweden Södra Älvsborgs Hospital Borås Västra Götaland

Sponsors (2)

Lead Sponsor Collaborator
Vastra Gotaland Region Child and Adolescent Psychiatry, Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to manual - therapists the therapists self-rate their compliance to the manual on a 4 point Likert scale. describing reasons to adverting from manual 10 weeks
Primary Change of Treatment satisfaction Level of satisfactions rated on a 5 point Likert scale. Higher scores indicates higher satisfaction. Change from baseline at 10 weeks
Secondary Change of Depression with Beck Depression Inventory BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher score indicate more severe depression. Change from baseline at 10 weeks
Secondary Change of quality of life measured with KIDSCREEN-10 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
Secondary Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P 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
Secondary Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS 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. Change from baseline at 10 weeks
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