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

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ClinicalTrials.gov Identifier: NCT01980381
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Kronoberg County Council

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).


Condition or disease Intervention/treatment Phase
Depression Anxiety Other: Tree Theme Method ® (TTM) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Depression and/or Anxiety - a Randomized Clinical Trial of the Tree Theme Method® (TTM) as an Intervention
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980381


Locations
Sweden
Kronoberg County Council
Växjö, Kronoberg, Sweden, 35242
Sponsors and Collaborators
Kronoberg County Council
Investigators
Study Chair: Birgitta A Gunnarsson, PhD Kronoberg CC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kronoberg County Council
ClinicalTrials.gov Identifier: NCT01980381     History of Changes
Other Study ID Numbers: LTK/120995
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders