DepressionNCT04603235
Manual-based Art Therapy for Adolescents With Depression
A study testing Manual-based Art Therapy in people with Depression and Depressive Disorder, run by Vastra Gotaland Region at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Manual-based Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 8 Oct 2020
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13-17 year
- Depression as main diagnosis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Depression, Depressive Disorder
- Being tested
- Manual-based Art Therapy
- Keywords
- art therapy, program development, Adolescent Health
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual-based Art TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a quasi-experimental study Receives: Behavioral: Manual-based Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Change of Treatment satisfaction
Level of satisfactions rated on a 5 point Likert scale. Higher scores indicates higher satisfaction.
Measured: Change from baseline at 10 weeks
Secondary outcomes (4)
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.
Measured: Change from baseline at 10 weeks
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.
Measured: Change from baseline at 10 weeks
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.
Measured: Change from baseline at 10 weeks
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.
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Jan 2019
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Child and Adolescent Psychiatry, Stockholm
- Responsible party
- Principal investigator, Christina Blomdahl, Vastra Gotaland Region
- Investigators
- Christina Blomdahl, PhD, Principal investigator, Region Vastra Gotaland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603235
- Sponsor's protocol ID
- 254011
- Status last verified
- Oct 2020
- First submitted
- 29 Jun 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual-based Art Therapy for Adolescents With Depression: a Pilot Study in Child and Youth Psychiatric Clinic in Sweden
- ClinicalTrials.gov ID
- NCT04603235
- Acronym / sponsor ID
- 254011
- Conditions
- Depression, Depressive Disorder
- Keywords
- art therapy, program development, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Child and Adolescent Psychiatry, Stockholm
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 26 Oct 2020 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Manual-based Art TherapyThis is a quasi-experimental study |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 13-17 year
- Depression as main diagnosis
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Manual-based Art TherapyThis 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. | Behavioural | Intervention |
Primary outcome
Adherence to manual - therapists
Time frame: 10 weeks
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
Time frame: Change from baseline at 10 weeks
Level of satisfactions rated on a 5 point Likert scale. Higher scores indicates higher satisfaction.
4 secondary outcomes
Change of Depression with Beck Depression Inventory BDI-II
Time frame: Change from baseline at 10 weeks
Change of quality of life measured with KIDSCREEN-10
Time frame: Change from baseline at 10 weeks
Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P
Time frame: Change from baseline at 10 weeks
Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS
Time frame: Change from baseline at 10 weeks
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 26 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Christina Blomdahl, PhD principal investigator
Region Vastra Gotaland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual-based Art Therapy in people with Depression and Depressive Disorder, run by Vastra Gotaland Region 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 2 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 26 Oct 2020. 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?
Adherence to manual - therapists (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 26 Oct 2020.