Stress DisorderNCT04832295
Photo-supported Conversations About Well-being
A study testing photo-supported conversations and Care as usual in people with Stress Disorder, run by Kronoberg County Council at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 67 years
- Conditions the study is for
- Stress Disorder
- What is being tested?
- photo-supported conversations and Care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stress related disorder F43.8 (ICD-10)
- stress related disorder F43.9 (ICD-10)
- on sick leave
- risk being on sick leave
Who cannot join
- severe somatic disorders
- neuropsychiatric diagnosis
- psychosis
- language problems that implies difficulties to answer questionnaires
- cognitive problems that implies difficulties to answer questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Kronoberg County Council
Vaxjo, 35242
Birgitta A Gunnarsson, PhD, +46470589078, birgitta.gunnarsson@kronoberg.se
About this study
Official title: A Study Protocol of the Photo-supported Conversations About Well-being Intervention in People With Stress Related Illness
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.
Read more
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.
Read the 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.
- Conditions
- Stress Disorder
- Being tested
- photo-supported conversations, Care as usual
- Keywords
- Health promotion
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photo-supported conversationsOther
Also called Be Well
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.
Care as usualOther
Medication, psychological treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Photo-supported conversations about well-being, in addition to care as usual Receives: Other: photo-supported conversations; Other: Care as usual |
| Control | Active comparator | Care as usual Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaustion
Symptoms of exhaustion measured by Karolinska Exhaustion Disorder Scale (KEDS) (Besèr et al., 2014) min=0 , max=54 , the higher the worse
Measured: Up to 9 months after enrollment
Work ability
Work ability measured by Worker Role Self-assessment (WRS-18) (Ekbladh et al., 2000) min=15 , max= 90, the higher the better
Measured: Up to 9 months after enrollment
Secondary outcomes (5)
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
Measured: Change from baseline to after treatment, and 6 months
Client Satisfaction
Client Satisfaction measured by the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979) min=8, max=32, the higher the better
Measured: Up to 9 months after enrollment
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
Measured: Up to 9 months after enrollment
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
Measured: Up to 9 months after enrollment
Sense of coherence
Sense of coherence measured with the Sense of Coherence Scale (SoC) ((Antonovsky, 1987), min=13, max=91, the higher the better
Measured: Up to 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jan 2020
- Primary completion30 Oct 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Collaborators
- Linnaeus University, Göteborg University, Jonkoping University, Region Jönköping County
- Responsible party
- Sponsor
- Investigators
- Birgitta A Gunnarsson, PhD, Study chair, Kronoberg County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832295
- Sponsor's protocol ID
- FORSS-847271
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34419148
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Protocol of the Photo-supported Conversations About Well-being Intervention in People With Stress Related Illness
- ClinicalTrials.gov ID
- NCT04832295
- Acronym / sponsor ID
- FORSS-847271
- Conditions
- Stress Disorder
- Keywords
- Health promotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kronoberg County CouncilOther government
- Collaborators
- Linnaeus University, Göteborg University, Jonkoping University, Region Jönköping County
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: photo-supported conversations, Other: Care as usualPhoto-supported conversations about well-being, in addition to care as usual |
| Control | Active comparator | Other: Care as usualCare as usual |
Who may qualify
- Ages
- 20 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stress related disorder F43.8 (ICD-10)
- stress related disorder F43.9 (ICD-10)
- on sick leave
- risk being on sick leave
Key exclusion criteria (5 listed)
- severe somatic disorders
- neuropsychiatric diagnosis
- psychosis
- language problems that implies difficulties to answer questionnaires
- cognitive problems that implies difficulties to answer questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photo-supported conversationsAlso: Be WellSessions 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. | Other | Intervention |
| Care as usualMedication, psychological treatment | Other | Control, Intervention |
Primary outcome
Exhaustion
Time frame: Up to 9 months after enrollment
Symptoms of exhaustion measured by Karolinska Exhaustion Disorder Scale (KEDS) (Besèr et al., 2014) min=0 , max=54 , the higher the worse
Work ability
Time frame: Up to 9 months after enrollment
Work ability measured by Worker Role Self-assessment (WRS-18) (Ekbladh et al., 2000) min=15 , max= 90, the higher the better
5 secondary outcomes
Balance of activities in everyday life
Time frame: Change from baseline to after treatment, and 6 months
Client Satisfaction
Time frame: Up to 9 months after enrollment
Depression and anxiety
Time frame: Up to 9 months after enrollment
Life quality
Time frame: Up to 9 months after enrollment
Sense of coherence
Time frame: Up to 9 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 34419148Gunnarsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgitta A Gunnarsson, PhD study chair
Kronoberg County Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photo-supported conversations and Care as usual in people with Stress Disorder, run by Kronoberg County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitta A Gunnarsson, PhD (+46470589078, birgitta.gunnarsson@kronoberg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaustion (time frame: Up to 9 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.