Clinical trial NCT01980381: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
First posted: 2013-11-11
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Psychological symptoms
timeFrame: Change from baseline to after treatment (6-9 weeks), 3 and 12 months
Secondary outcomes:
measure: Everyday occupations
timeFrame: Change from baseline, after treatment (6-9 weeks), and 3 and 12 months
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Kronoberg County Council
state: Kronoberg
Study officials:
affiliation: Kronoberg CC
name: Birgitta A Gunnarsson, PhD
role: STUDY_CHAIR
References:
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.
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.