NCT01980381

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable depression

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, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

12 years

First QC Date

August 6, 2013

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    Change from baseline to after treatment (6-9 weeks), 3 and 12 months

Secondary Outcomes (1)

  • Everyday occupations

    Change from baseline, after treatment (6-9 weeks), and 3 and 12 months

Study Arms (2)

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.

Other: Tree Theme Method ® (TTM)

Control group

NO INTERVENTION

Treatment as usual, with focus on the present everyday occupations

Interventions

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.

Tree Theme Method ® (TTM) intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depression and/or anxiety in age of 18-65 years and problems with everyday occupations.

You may not qualify if:

  • Severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kronoberg County Council

Vaxjo, Kronoberg County, 35242, Sweden

Location

Related Publications (3)

  • 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.

  • Birgitta 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.

  • Gunnarsson 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Birgitta A Gunnarsson, PhD

    Kronoberg CC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

November 11, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations