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Manual-based Art Therapy for Adolescents With Depression

Primary Purpose

Depression, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Manual-based Art Therapy
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring art therapy, program development, Adolescent Health

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Södra Älvsborgs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

This is a quasi-experimental study

Outcomes

Primary Outcome Measures

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
Change of Treatment satisfaction
Level of satisfactions rated on a 5 point Likert scale. Higher scores indicates higher satisfaction.

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
June 29, 2020
Last Updated
October 20, 2020
Sponsor
Vastra Gotaland Region
Collaborators
Child and Adolescent Psychiatry, Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04603235
Brief Title
Manual-based Art Therapy for Adolescents With Depression
Official Title
Manual-based Art Therapy for Adolescents With Depression: a Pilot Study in Child and Youth Psychiatric Clinic in Sweden
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Child and Adolescent Psychiatry, Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder
Keywords
art therapy, program development, Adolescent Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The participants identities are masked for researchers
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This is a quasi-experimental study
Intervention Type
Behavioral
Intervention Name(s)
Manual-based Art Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to manual - therapists
Description
the therapists self-rate their compliance to the manual on a 4 point Likert scale. describing reasons to adverting from manual
Time Frame
10 weeks
Title
Change of Treatment satisfaction
Description
Level of satisfactions rated on a 5 point Likert scale. Higher scores indicates higher satisfaction.
Time Frame
Change from baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Change of Depression with Beck Depression Inventory BDI-II
Description
contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher score indicate more severe depression.
Time Frame
Change from baseline at 10 weeks
Title
Change of quality of life measured with KIDSCREEN-10
Description
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.
Time Frame
Change from baseline at 10 weeks
Title
Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P
Description
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.
Time Frame
Change from baseline at 10 weeks
Title
Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS
Description
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.
Time Frame
Change from baseline at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Blomdahl, PhD
Organizational Affiliation
Region Vastra Gotaland, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södra Älvsborgs Hospital
City
Borås
State/Province
Västra Götaland
ZIP/Postal Code
50182
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Manual-based Art Therapy for Adolescents With Depression

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