Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention
Primary Purpose
Depression, Anxiety
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tree Theme Method ® (TTM)
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Kronoberg County Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tree Theme Method ® (TTM) intervention
Control group
Arm Description
The TTM involves storytelling and story making, in which the patient draws tree maps representing certain periods of his/her life.
Treatment as usual, with focus on the present everyday occupations
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01980381
Brief Title
Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention
Official Title
Treatment of Depression and/or Anxiety - a Randomized Clinical Trial of the Tree Theme Method® (TTM) as an Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kronoberg County Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tree Theme Method ® (TTM) intervention
Arm Type
Experimental
Arm Description
The TTM involves storytelling and story making, in which the patient draws tree maps representing certain periods of his/her life.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual, with focus on the present everyday occupations
Intervention Type
Other
Intervention Name(s)
Tree Theme Method ® (TTM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychological symptoms
Description
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)
Time Frame
Change from baseline to after treatment (6-9 weeks), 3 and 12 months
Secondary Outcome Measure Information:
Title
Everyday occupations
Description
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).
Time Frame
Change from baseline, after treatment (6-9 weeks), and 3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta A Gunnarsson, PhD
Organizational Affiliation
Kronoberg CC
Official's Role
Study Chair
Facility Information:
Facility Name
Kronoberg County Council
City
Växjö
State/Province
Kronoberg
ZIP/Postal Code
35242
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29792226
Citation
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.
Results Reference
derived
PubMed Identifier
26552426
Citation
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.
Results Reference
derived
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Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention
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