Clinical trial NCT04832295: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorder
Keywords: Health promotion
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
Collaborators: name: Linnaeus University
name: Göteborg University
name: Jonkoping University
name: Region Jönköping County
First posted: 2021-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exhaustion
timeFrame: Up to 9 months after enrollment
measure: Work ability
timeFrame: Up to 9 months after enrollment
Secondary outcomes:
measure: Balance of activities in everyday life
timeFrame: Change from baseline to after treatment, and 6 months
measure: Client Satisfaction
timeFrame: Up to 9 months after enrollment
measure: Depression and anxiety
timeFrame: Up to 9 months after enrollment
measure: Life quality
timeFrame: Up to 9 months after enrollment
measure: Sense of coherence
timeFrame: Up to 9 months after enrollment
Other outcomes:
measure: Interview
timeFrame: Up to 9 months after enrollment
Locations:
city: Växjö
country: Sweden
facility: Kronoberg County Council
Study officials:
affiliation: Kronoberg County Council
name: Birgitta A Gunnarsson, PhD
role: STUDY_CHAIR
References:
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.