NCT04832295

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Dec 2026

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

April 1, 2021

Last Update Submit

March 6, 2025

Conditions

Keywords

Health promotion

Outcome Measures

Primary Outcomes (2)

  • Exhaustion

    Symptoms of exhaustion measured by Karolinska Exhaustion Disorder Scale (KEDS) (Besèr et al., 2014) min=0 , max=54 , the higher the worse

    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

    Up to 9 months after enrollment

Secondary Outcomes (5)

  • Balance of activities in everyday life

    Change from baseline to after treatment, and 6 months

  • Client Satisfaction

    Up to 9 months after enrollment

  • Depression and anxiety

    Up to 9 months after enrollment

  • Life quality

    Up to 9 months after enrollment

  • Sense of coherence

    Up to 9 months after enrollment

Other Outcomes (1)

  • Interview

    Up to 9 months after enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: photo-supported conversationsOther: Care as usual

Control

ACTIVE COMPARATOR

Care as usual

Other: Care as usual

Interventions

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.

Also known as: Be Well
Intervention

Medication, psychological treatment

ControlIntervention

Eligibility Criteria

Age20 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kronoberg County Council

Vaxjo, 35242, Sweden

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Birgitta A Gunnarsson, PhD

    Kronoberg County Council

    STUDY CHAIR

Central Study Contacts

Birgitta A Gunnarsson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

January 1, 2020

Primary Completion

October 30, 2024

Study Completion (Estimated)

December 30, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations