Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photo-supported Conversations About Well-being

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832295
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Linnaeus University
Göteborg University
Jonkoping University
Region Jönköping County
Information provided by (Responsible Party):
Kronoberg County Council

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 50 patients (25 to the intervention group and 25 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.


Condition or disease Intervention/treatment Phase
Stress Disorder Other: photo-supported conversations Other: Care as usual Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Protocol of the Photo-supported Conversations About Well-being Intervention in People With Stress Related Illness
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Intervention
Photo-supported conversations about well-being, in addition to care as usual
Other: photo-supported conversations

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.

Other Name: Be Well

Other: Care as usual
Medication, psychological treatment

Active Comparator: Control
Care as usual
Other: Care as usual
Medication, psychological treatment




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Balance of activities in everyday life [ Time Frame: Change from baseline to after treatment, and 6 months ]
    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

  2. Client Satisfaction [ Time Frame: Up to 9 months after enrollment ]
    Client Satisfaction measured by the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979) min=8, max=32, the higher the better

  3. Depression and anxiety [ Time Frame: Up to 9 months after enrollment ]
    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

  4. Life quality [ Time Frame: Up to 9 months after enrollment ]
    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

  5. Sense of coherence [ Time Frame: Up to 9 months after enrollment ]
    Sense of coherence measured with the Sense of Coherence Scale (SoC) ((Antonovsky, 1987), min=13, max=91, the higher the better


Other Outcome Measures:
  1. Interview [ Time Frame: Up to 9 months after enrollment ]
    situation in everyday life, and what causes stress at home and at work, and what contributes to well-being despite living with stress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04832295


Contacts
Layout table for location contacts
Contact: Birgitta A Gunnarsson, PhD +46470589078 birgitta.gunnarsson@kronoberg.se

Locations
Layout table for location information
Sweden
Kronoberg County Council Recruiting
Växjö, Sweden, 35242
Contact: Birgitta A Gunnarsson, PhD    +46470589078    birgitta.gunnarsson@kronoberg.se   
Sponsors and Collaborators
Kronoberg County Council
Linnaeus University
Göteborg University
Jonkoping University
Region Jönköping County
Investigators
Layout table for investigator information
Study Chair: Birgitta A Gunnarsson, PhD Kronoberg County Council
Layout table for additonal information
Responsible Party: Kronoberg County Council
ClinicalTrials.gov Identifier: NCT04832295    
Other Study ID Numbers: FORSS-847271
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kronoberg County Council:
Health promotion
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders