DepressionNCT01980381
Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention
A study testing Tree Theme Method ® (TTM) in people with Depression and Anxiety, run by Kronoberg County Council at 1 site in Sweden.
Trial summary
Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Tree Theme Method ® (TTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jul 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depression and/or anxiety in age of 18-65 years and problems with everyday occupations.
Who cannot join
- Severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Depression and/or Anxiety - a Randomized Clinical Trial of the Tree Theme Method® (TTM) as an Intervention
Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions.
The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board.
Read more
The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires.
The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health.
The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).
- Conditions
- Depression, Anxiety
- Being tested
- Tree Theme Method ® (TTM)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tree Theme Method ® (TTM)Other
The TTM method is based on creative activities and occupational life story telling, implies that the paints trees representing different life periods, looking back and forward, as well as the present.
| Study group | Role | What they receive |
|---|---|---|
| Tree Theme Method ® (TTM) intervention | Experimental | The TTM involves storytelling and story making, in which the patient draws tree maps representing certain periods of his/her life. Receives: Other: Tree Theme Method ® (TTM) |
| Control group | No intervention | Treatment as usual, with focus on the present everyday occupations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological symptoms
Psychological symptoms measured by the SCL-90-R(Derogatis, 1992) Depression measured by the MADRS-S(Montgomery \& Åsberg, 1979) Anxiety/depression measured by the HAD(Zigmond \& Snaith, 1983)
Measured: Change from baseline to after treatment (6-9 weeks), 3 and 12 months
Secondary outcomes (1)
Everyday occupations
Everyday occupations measured by the Occupational performance and satisfaction with occupational performance measured (COPM)(Law et al., 1998), the Satisfaction with Daily occupations (SDO)(Eklund, 2004)and the Occupational balance (Wagman, Håkansson \& Björklund, 2011).
Measured: Change from baseline, after treatment (6-9 weeks), and 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2025
- Study completionJul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Birgitta A Gunnarsson, PhD, Study chair, Kronoberg CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980381
- Sponsor's protocol ID
- LTK/120995
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2013
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eklund M, Gunnarsson AB. The relevance of employing a three-perspective view on occupational balance among people with depression and/or anxiety disorders. Scand J Occup Ther. 2025 Mar 6;32(1):2474853. doi: 10.1080/11038128.2025.2474853. Epub 2025 Mar 19.
PubMed 40104977Birgitta Gunnarsson A, Wagman P, Hedin K, Hakansson C. Treatment of depression and/or anxiety - outcomes of a randomised controlled trial of the tree theme method(R) versus regular occupational therapy. BMC Psychol. 2018 May 23;6(1):25. doi: 10.1186/s40359-018-0237-0.
PubMed 29792226Gunnarsson AB, Wagman P, Hakansson C, Hedin K. The Tree Theme Method(R) (TTM), an occupational therapy intervention for treating depression and anxiety: study protocol of a randomized controlled trial. BMC Psychol. 2015 Nov 9;3:40. doi: 10.1186/s40359-015-0097-9.
PubMed 26552426
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression and/or Anxiety - a Randomized Clinical Trial of the Tree Theme Method® (TTM) as an Intervention
- ClinicalTrials.gov ID
- NCT01980381
- Acronym / sponsor ID
- LTK/120995
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Kronoberg County CouncilOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jul 2025 (actual)
- First posted
- 11 Nov 2013 (estimated)
- 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.
Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions.
The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board.
The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires.
The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health.
The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tree Theme Method ® (TTM) intervention | Experimental | Other: Tree Theme Method ® (TTM)The TTM involves storytelling and story making, in which the patient draws tree maps representing certain periods of his/her life. |
| Control group | No intervention | –Treatment as usual, with focus on the present everyday occupations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Depression and/or anxiety in age of 18-65 years and problems with everyday occupations.
Key exclusion criteria (1 listed)
- Severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires
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 |
|---|---|---|
| Tree Theme Method ® (TTM)The TTM method is based on creative activities and occupational life story telling, implies that the paints trees representing different life periods, looking back and forward, as well as the present. | Other | Tree Theme Method ® (TTM) intervention |
Primary outcome
Psychological symptoms
Time frame: Change from baseline to after treatment (6-9 weeks), 3 and 12 months
Psychological symptoms measured by the SCL-90-R(Derogatis, 1992) Depression measured by the MADRS-S(Montgomery \& Åsberg, 1979) Anxiety/depression measured by the HAD(Zigmond \& Snaith, 1983)
1 secondary outcome
Everyday occupations
Time frame: Change from baseline, after treatment (6-9 weeks), and 3 and 12 months
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 29 Aug 2025.
- Derived from this study: PubMed 40104977Eklund M, Gunnarsson AB. The relevance of employing a three-perspective view on occupational balance among people with depression and/or anxiety disorders. Scand J Occup Ther. 2025 Mar 6;32(1):2474853. doi: 10.1080/11038128.2025.2474853. Epub 2025 Mar 19.
- Derived from this study: PubMed 29792226Birgitta Gunnarsson A, Wagman P, Hedin K, Hakansson C. Treatment of depression and/or anxiety - outcomes of a randomised controlled trial of the tree theme method(R) versus regular occupational therapy. BMC Psychol. 2018 May 23;6(1):25. doi: 10.1186/s40359-018-0237-0.
- Derived from this study: PubMed 26552426Gunnarsson AB, Wagman P, Hakansson C, Hedin K. The Tree Theme Method(R) (TTM), an occupational therapy intervention for treating depression and anxiety: study protocol of a randomized controlled trial. BMC Psychol. 2015 Nov 9;3:40. doi: 10.1186/s40359-015-0097-9.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Birgitta A Gunnarsson, PhD study chair
Kronoberg CC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tree Theme Method ® (TTM) in people with Depression and Anxiety, run by Kronoberg County Council 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 1 inclusion and 1 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 29 Aug 2025. 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?
Psychological symptoms (time frame: Change from baseline to after treatment (6-9 weeks), 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980381, which also lists 3 linked publications.
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 29 Aug 2025.