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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01980381
• Other study ID #: LTK/120995
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Kronoberg County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	Kronoberg County Council	Växjö	Kronoberg

Sponsors (1)

Lead Sponsor	Collaborator
Kronoberg County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Change from baseline, after treatment (6-9 weeks), and 3 and 12 months