CClinicalTrials.gg
Status unknownNCT02981563TTUpdated Oct 26, 2017

Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design

An interventional study of Time Together in Mental Health Nursing and Nurse-Patient Relations, sponsored by Umeå University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Umeå University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this project is to test and evaluate a nursing intervention, Time Together (TT), created to enable quality interactions between patients and staff in psychiatric inpatient care. The research questions are:

Does TT influence the quality of interactions between staff and patients? Does TT influence patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of perceived stress and levels of stress of conscience? Does TT influence the prevalence of coercive measures, mean length of hospital stay and the use of PRN medication?

In parallel, a process evaluation will be conducted, answering questions such as:

How do staff and patients describe their experiences of the intervention and how do contextual factors influence the effects of the intervention? What are the relationship between the outcome variables and the degree of compliance with the intended intervention? What problems are there with recruitment and dropouts?

Read the detailed description

BACKGROUND:

Despite the long known significance of the nurse-patient relationship, research in psychiatric inpatient care still reports on unfulfilled expectations of, and difficulties in interactions and relationships between patients and staff. As one solution to the contemporary circumstances, interventions that creates structures that allow quality interactions between patients and staff are needed.

INTERVENTION TT is an intervention, developed from the intervention Protected Engagement Time. The structure of TT is that staff, for a fixed time during the day, dedicates their time to exclusively engage with the patients. Other duties of more administrative nature, visits and meetings are organized to be performed at other times during the day. This structure will be tested at three psychiatric inpatient care wards in the north of Sweden.

DESIGN AND METHODS An experimental single system design (A-B-Follow-up) will be used. As TT will be introduced as a routine ward activity during the B phase, all patients and staff on the participating wards will be participating in TT. However, participating in the evaluation will be voluntary. Data will be collected through questionnaires once every seventh weekday during 5 weeks for the A phase, and 12 weeks during B phase.

In parallel, a process evaluation will be conducted using semi structured interviews and participating observations.

02

Conditions studied

  • Mental Health Nursing
  • Nurse-Patient Relations

Keywords

  • engagement
  • psychiatric in-patient care
  • mental health nursing
  • quality interactions
03

In context

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria for patients:

  • 18 years or older
  • Admitted to the wards during either A phase, B phase and/or follow-up
  • Experience of at least one TT session is required to participate in the B phase

Exclusion criteria for patients:

  • Does not master the Swedish language well enough to complete questionnaires and participate in interviews.

Inclusion criteria for staff:

  • Regularly employed at the ward during A and B phase and/or follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • Experimental
    Time Together

    Time Together as described under "Interventions"

    Other: Time Together

Interventions

  • OtherTime Together

    For a fixed time during the day, staff dedicates their time to exclusively engage with the patients. Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations. Other duties of more administrative nature, visits and meetings will be performed at other times during the day. Through this, opportunities for interaction are both created and protected.

    Also known as: Protected Engagement Time

06

What researchers measure

Primary outcomes

  1. Quality of interactions [patients]

    This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  2. Perceived stress [staff]

    PSS consists of 10 items answered on a 5-point Likert scale

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

Secondary outcomes

  1. Global quality of interactions [patients, staff]

    A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  2. Anxiety and depressive symptoms [patients]

    The Hospital Anxiety and Depression Scale (HAD) will be used to measure anxiety and depressive symptoms. All items are scored on a 4-point scale.

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  3. Stress of Conscience [staff]

    The Stress of Conscience Questionnaire (SCQ) will be used to measure the frequencies of stressful situations and the degree to which these lead to stress of conscience among staff.

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  4. Quality of care [staff]

    The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.

    Time frame: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  5. Number of PRN medications given

    Data will be retrieved from ward registers.

    Time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)

  6. Length of hospital stay

    Data will be retrieved from ward registers.

    Time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)

  7. Use of coercion and violent situations

    Data will be retrieved from ward registers.

    Time frame: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Molin J, Lindgren BM, Graneheim UH, Ringner A. Does 'Time Together' increase quality of interaction and decrease stress? A study protocol of a multisite nursing intervention in psychiatric inpatient care, using a mixed method approach. BMJ Open. 2017 Aug 28;7(8):e015677. doi: 10.1136/bmjopen-2016-015677. PubMed 28851774 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02981563
Lead sponsor
Umeå University
Responsible party
Sponsor
First posted
Dec 5, 2016
Start date
Jan 2017
Primary completion
Jun 2017
Completion
Nov 2017 (estimated)
Last update
Oct 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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