NCT04603235

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

June 29, 2020

Last Update Submit

October 20, 2020

Conditions

DepressionDepressive Disorder

Keywords

art therapyprogram developmentAdolescent Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change of Depression with Beck Depression Inventory BDI-II

    Change from baseline at 10 weeks

  • Change of quality of life measured with KIDSCREEN-10

    Change from baseline at 10 weeks

  • Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P

    Change from baseline at 10 weeks

  • Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS

    Change from baseline at 10 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

This is a quasi-experimental study

Behavioral: Manual-based Art Therapy

Interventions

Manual-based Art TherapyBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 13-17 year
  • Depression as main diagnosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södra Älvsborgs Hospital

Borås, Västra Götaland County, 50182, Sweden

Location

MeSH Terms

Conditions

DepressionDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Christina Blomdahl, PhD

    Region Vastra Gotaland, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The participants identities are masked for researchers
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and Development manager

Study Record Dates

First Submitted

June 29, 2020

First Posted

October 26, 2020

Study Start

January 1, 2019

Primary Completion

October 8, 2020

Study Completion

October 8, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)