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Photo-supported Conversations About Well-being

Primary Purpose

Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
photo-supported conversations
Care as usual
Sponsored by
Kronoberg County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorder focused on measuring Health promotion

Eligibility Criteria

20 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stress related disorder F43.8 (ICD-10)
  • stress related disorder F43.9 (ICD-10)
  • on sick leave
  • risk being on sick leave

Exclusion Criteria:

  • severe somatic disorders
  • neuropsychiatric diagnosis
  • psychosis
  • language problems that implies difficulties to answer questionnaires
  • cognitive problems that implies difficulties to answer questionnaires

Sites / Locations

  • Kronoberg County CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Photo-supported conversations about well-being, in addition to care as usual

Care as usual

Outcomes

Primary Outcome Measures

Exhaustion
Symptoms of exhaustion measured by Karolinska Exhaustion Disorder Scale (KEDS) (Besèr et al., 2014) min=0 , max=54 , the higher the worse
Work ability
Work ability measured by Worker Role Self-assessment (WRS-18) (Ekbladh et al., 2000) min=15 , max= 90, the higher the better

Secondary Outcome Measures

Balance of activities in everyday life
Balance of activities in everyday life measured by the Occupational Balance questionnaire (OBQ11) (Håkansson et al., 2020) min=0 , max=33, the higher the better
Client Satisfaction
Client Satisfaction measured by the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979) min=8, max=32, the higher the better
Depression and anxiety
Symptoms of Depression and anxiety measured by the Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983), min=0, max=42, the higher the worse
Life quality
Quality of life measured with the Manchester Short Assessment of quality of life (MANSA) (Priebe et al., 1999), min=12, max=84, the higher the better
Sense of coherence
Sense of coherence measured with the Sense of Coherence Scale (SoC) ((Antonovsky, 1987), min=13, max=91, the higher the better

Full Information

First Posted
April 1, 2021
Last Updated
February 20, 2023
Sponsor
Kronoberg County Council
Collaborators
Linnaeus University, Göteborg University, Jonkoping University, Region Jönköping County
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1. Study Identification

Unique Protocol Identification Number
NCT04832295
Brief Title
Photo-supported Conversations About Well-being
Official Title
A Study Protocol of the Photo-supported Conversations About Well-being Intervention in People With Stress Related Illness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kronoberg County Council
Collaborators
Linnaeus University, Göteborg University, Jonkoping University, Region Jönköping County

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
The aim is to to investigate photo-supported conversations about well-being by the intervention Be WellTM in addition to care as usual within primary care, compared to a control group, for patients with stress-related diagnosis. The intention is to examine the outcomes measures regarding exhaustion, balance of activities in everyday life, client satisfaction, depression and anxiety quality of life, sense of coherence and work ability. The study has been approved by the Regional Ethical Review Board. The project has a quasi-experimental design using mixed methods. A total of 70 patients (35 to the intervention group and 35 to the control group) will be included. Inclusion criteria are patients with stress-related disorder in primary care, aged 20-67 years, who are on sick leave or risk being on sick leave. Exclusion criteria are severe somatic disorders, neuropsychiatric diagnosis, psychosis and language or cognitive problems that implies difficulties to answer questionnaires. After informed consent, the intervention group receive, in addition to care as usual, photo-supported conversations about well-being, that is conducted over time for increased training. The intervention involves 12 sessions takes part during 12-15weeks. With cell phones the patients photograph what they relate to well-being in everyday life. The photos are enlarged and used for reflecting conversations with their therapist. Before and after intervention, and 6 months after intervention the patient meets a project assistant and respond questionnaires as well as qualitative interviews. The control group has the same measure points. Outcome measures are compared with a control group who receive care as usual in primary care. Data will be collected by questionnaires for exhaustion, balance of activities in everyday life, client satisfaction, depression and anxiety, quality of life, sense of coherence and work ability. Qualitative data from interviews about life situation and treatment experiences will also be analyzed. An additional aim is to investigate how therapists experience performing a health promoting intervention, collected from qualitative interviews. The project is involving the Kronoberg County Council and Jönköping County Council. Gatekeepers will recruit patients and occupational therapists will perform the intervention. The research team comprise of researchers from Kronoberg County Council, Linnaeus University, Jönköping University and University of Gothenburg.
Detailed Description
The project has the following research questions: How are the participants' work ability, health and well-being affected by the photo-supported intervention? Primary outcome is self-rated symptoms of exhaustion. Secondary outcomes are self-rated balance of activities in everyday life, client satisfaction, depression and anxiety, quality of life, sense of coherence and work ability. The interviews deals about: How do the participants perceive their life situation, within as well as beyond paid work, before and after the intervention? How do the participants perceive their participation photo-supported conversations about well-being intervention (Be Well)? How do the therapists perceive the delivery of the intervention "Be Well"? Non-parametric statistics will be used for analyzing quantitative data. Thematic, phenomenological, qualitative content analyses and semiotic methods will be used for qualitative data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder
Keywords
Health promotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Photo-supported conversations about well-being, in addition to care as usual
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Care as usual
Intervention Type
Other
Intervention Name(s)
photo-supported conversations
Other Intervention Name(s)
Be Well
Intervention Description
Sessions 1-4: Before each of the sessions, the client photographs that which is related to their well-being and send these to the therapist before the session. The therapist enlarges each of the photographs into the size of A4. The conversation departures from the photographs and the client is encouraged to talk about each of them and they ways it relates to their well-being. Potential strategies for everyday life are discussed. Session 5-10: short virtual meetings of approximately 15-20 minutes with the aim to follow the client, confirm their process and support them towards increased well-being. Session 11: reflecting upon all their previous photographs. Session 12: reflecting future everyday life upon their photographs.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
Medication, psychological treatment
Primary Outcome Measure Information:
Title
Exhaustion
Description
Symptoms of exhaustion measured by Karolinska Exhaustion Disorder Scale (KEDS) (Besèr et al., 2014) min=0 , max=54 , the higher the worse
Time Frame
Up to 9 months after enrollment
Title
Work ability
Description
Work ability measured by Worker Role Self-assessment (WRS-18) (Ekbladh et al., 2000) min=15 , max= 90, the higher the better
Time Frame
Up to 9 months after enrollment
Secondary Outcome Measure Information:
Title
Balance of activities in everyday life
Description
Balance of activities in everyday life measured by the Occupational Balance questionnaire (OBQ11) (Håkansson et al., 2020) min=0 , max=33, the higher the better
Time Frame
Change from baseline to after treatment, and 6 months
Title
Client Satisfaction
Description
Client Satisfaction measured by the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979) min=8, max=32, the higher the better
Time Frame
Up to 9 months after enrollment
Title
Depression and anxiety
Description
Symptoms of Depression and anxiety measured by the Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983), min=0, max=42, the higher the worse
Time Frame
Up to 9 months after enrollment
Title
Life quality
Description
Quality of life measured with the Manchester Short Assessment of quality of life (MANSA) (Priebe et al., 1999), min=12, max=84, the higher the better
Time Frame
Up to 9 months after enrollment
Title
Sense of coherence
Description
Sense of coherence measured with the Sense of Coherence Scale (SoC) ((Antonovsky, 1987), min=13, max=91, the higher the better
Time Frame
Up to 9 months after enrollment
Other Pre-specified Outcome Measures:
Title
Interview
Description
situation in everyday life, and what causes stress at home and at work, and what contributes to well-being despite living with stress
Time Frame
Up to 9 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stress related disorder F43.8 (ICD-10) stress related disorder F43.9 (ICD-10) on sick leave risk being on sick leave Exclusion Criteria: severe somatic disorders neuropsychiatric diagnosis psychosis language problems that implies difficulties to answer questionnaires cognitive problems that implies difficulties to answer questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitta A Gunnarsson, PhD
Phone
+46470589078
Email
birgitta.gunnarsson@kronoberg.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta A Gunnarsson, PhD
Organizational Affiliation
Kronoberg County Council
Official's Role
Study Chair
Facility Information:
Facility Name
Kronoberg County Council
City
Växjö
ZIP/Postal Code
35242
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitta A Gunnarsson, PhD
Phone
+46470589078
Email
birgitta.gunnarsson@kronoberg.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
34419148
Citation
Gunnarsson AB, Wagman P, Sternudd HT, Holmberg S, Holmgren K, Horberg U. A study protocol of the photo-supported conversations about the well-being intervention (Be Well) for people with stress related disorders. BMC Psychol. 2021 Aug 21;9(1):123. doi: 10.1186/s40359-021-00625-3.
Results Reference
derived

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Photo-supported Conversations About Well-being

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