Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention

August 5, 2021 updated by: Kronoberg County Council

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.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Kronoberg
      • Växjö, Kronoberg, Sweden, 35242
        • Kronoberg County Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tree Theme Method ® (TTM) intervention
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)
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.
No Intervention: Control group
Treatment as usual, with focus on the present everyday occupations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to after treatment (6-9 weeks), 3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Everyday occupations
Time Frame: Change from baseline, after treatment (6-9 weeks), and 3 and 12 months
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).
Change from baseline, after treatment (6-9 weeks), and 3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kronoberg County Council

Investigators

  • Study Chair: Birgitta A Gunnarsson, PhD, Kronoberg CC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTK/120995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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