Psychological RecoveryNCT06476483
Feasibility and Acceptability of Implementing DIALOG+ in a Psychiatric Rehabilitation Unit
A study testing DIALOG+ and DIALOG in people with Psychological Recovery, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
This study aims to understand if implementing DIALOG+ in an inpatient psychiatric rehabilitation setting is feasible (can the intervention be implemented) and acceptable (how the intervention is perceived by staff and patient participants). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Recovery
- What is being tested?
- DIALOG+ and DIALOG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2024to 24 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-65
- Capacity to give informed consent as determined by the MDT and through following informed consent processes.
- Admitted into the inpatient ward
- Can complete DIALOG and DIALOG+
Who cannot join
- No capacity to consent
- Insufficient command of the English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing the DIALOG Outcome Measure and a Solution-Focused Intervention (DIALOG+) in a Rehabilitation Psychiatric Inpatient Setting: A Mixed Methods Feasibility Study
This study aims to understand if implementing DIALOG+ in an inpatient psychiatric rehabilitation setting is feasible (can the intervention be implemented) and acceptable (how the intervention is perceived by staff and patient participants). If the intervention is proven to be feasible and acceptable a larger-scale study may take place. This study has been developed in response to the trust-wide implementation of DIALOG outcome measures. DIALOG+ offers additional solution-focused and person-centred follow-up questions to the DIALOG questions and links to multidisciplinary team (MDT) discussions. It is hoped that the conversations had during DIALOG+ meetings will support positive outcomes, and the learning gathered from this study will drive change and improvement for other people requiring psychiatric rehabilitation inpatient admissions in the future. DIALOG+ has been successfully implemented in community settings in the national health service (NHS) but has not been implemented in psychiatric rehabilitation inpatient settings. This study will aim to recruit patient and staff participants from NHS psychiatric rehabilitation inpatient wards. Patient participants who will be eligible to take part are those who can consent, are between the ages of 18-65, and can complete DIALOG and DIALOG+. To understand the feasibility of the intervention, descriptive statistics will be collected and to understand acceptability focus groups will take place and surveys will be collected. Quantitative data collection will take place over 5 months and will be split into 2 groups. Group one will be a comparison group where participants will act as an extended baseline group and biweekly DIALOG outcomes will be collected. Group 2 will be a Treatment group and participants will receive the DIALOG+ intervention intervention, DIALOG outcomes will be collected biweekly as part of the intervention. Finally, there will be a period to gather qualitative feedback from patient participants using surveys, and from staff participants using focus groups or semi-structured interviews.
- Conditions
- Psychological Recovery
- Being tested
- DIALOG+, DIALOG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIALOG+Behavioural
A person-centred and solution-focused intervention linked to the DIALOG outcome measure (a measure of patient experience and quality of life).
DIALOGBehavioural
An outcome measure consisting of 11 questions, with 8 related to quality of life and 3 items on treatment satisfaction. Patients can rate their satisfaction on a 7-point scale for each of the 8 life domains and 3 treatment aspects, resulting in scores for both quality of life and treatment satisfaction. The DIALOG scale does not provide any guidance for patient and clinician interactions.
| Study group | Role | What they receive |
|---|---|---|
| DIALOG | Other | This is the comparison group, they will complete the DIALOG measure biweekly for 5 months. DIALOG scores pre and post-intervention will be used in the analyses. Receives: Behavioral: DIALOG |
| DIALOG+ | Active comparator | This is the treatment group. The participants in this group have agreed to participate in DIALOG+ and will receive the intervention biweekly for 10 sessions (5 months). Pre and post-intervention DIALOG scores will be used in the analysis. Receives: Behavioral: DIALOG+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome- Recruitment rate/consent rate
The number of people who agreed and consented to participate in the study out of the total number of eligible participants approached. Reported as a percentage.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- Number of eligible participants.
Eligible participants are those who meet the inclusion criteria, reported as a count of participants.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- Participation rate
The proportion of those who consented and agreed to engage in DIALOG and DIALOG+ out of the number of participants who engaged in the intervention after consenting. Reported as a percentage of participants.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- Completion rate
The proportion of those who completed the intervention out of the number who consented and engaged in DIALOG and DIALOG+. Reported as a percentage of participants.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- Drop out rate
The number of participants who completed the intervention out of total number of patients enrolled. Reported as a percentage of participants.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcomes- Reasons for drop out
Reasons for drop out will be assessed when by asking the participant after drop out.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcomes- Follow up rate
The number of patients willing to engage in follow-up surveys related to the study out of the total number of participants enrolled in the study. Reported as a percentage of participants.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- The willingness of clinicians to recruit participants
Number of staff members who attend DIALOG+ training and implement intervention out of the total number of staff offered to participate. Reported as a percentage.
Measured: assessed at the end of the study (after 5 months)
Feasibility outcome- Average number of DIALOG+ sessions
Reported as the average number of participants.
Measured: assessed at the end of the study (5 months)
Acceptability outcome- Cost
Analysing the cost and benefits of implementing the intervention (including staff training). Reported as a total amount or duration of time spent on training (minutes).
Measured: assessed at the end of the study (after 5 months)
Number of staff participants who find DIALOG and DIALOG+ feasible and acceptable to implement in an inpatient rehabilitation setting. Assessed using thematic analysis of focus groups.
To assess the acceptability of the intervention a theoretical framework (Sekhon et al., 2017) was used. Feasibility objectives are defined by Bugge et al., 2013. Focus group transcripts will be subject to a qualitative thematic analysis. Analysis of focus groups will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview with in relation to the research question (Braun \& Clarke, 2006).
Measured: assessed at the end of the study (after 5 months)
Number of patients who find it feasible and acceptable to implement DIALOG and DIALOG+ in an inpatient rehabilitation setting. Assessed using thematic analysis and average scores of patient surveys.
The questionnaires will be a mixture of open ended questions and Likert Scale questions based on questions asked by Matanov et al. (2021), 8 of the questions are scored on a Likert scale (1-5). The survey will be given to patients post-intervention. Questions on the scale have been specifically developed to assess feasibility and acceptability of DIALOG+. An average total score will be used in the analysis of Likert scale questions. Open-ended questionnaire responses will be subject to a qualitative thematic analysis. Analysis will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview in relation to the research question (Braun \& Clarke, 2006).
Measured: assessed at the end of the study (after 5 months)
Secondary outcomes (3)
DIALOG questionnaire
The DIALOG questionnaire consists of 11 questions, with 8 items related to subjective quality of life (SQOL) and 3 items on treatment satisfaction. Patients can rate their satisfaction on a 7-point scale for each of the 8 life domains and 3 treatment aspects, resulting in scores for both SQOL and treatment satisfaction. An increase in score indicates improvement.
The dependent variable will be DIALOG outcomes at the end of intervention or discharge and the independent variable will be the group binary variable (intervention or comparison group). Data will be analysed using a linear regression model to assess whether implementing DIALOG+ as an intervention in addition to using the DIALOG outcome measure, leads to improved outcomes.
The unit of measure: reported as an average total score.
Measured: At the beginning of the study, then biweekly for a duration of 5 months with the final measure taken after 5 months
Demographic information
To gather demographic details from patients to assess the potential generalisability of DIALOG and DIALOG+. • Demographic information includes age, gender, ethnicity, history of mental illness or previous inpatient admissions, drug-use, diagnosis, baseline severity on DIALOG, and length of stay. Reported as a percentage of participants.
Measured: assessed at the end of the study (5 months)
Length of admission in months
To use regression analysis to understand the effectiveness of the intervention and impact on admission length and DIALOG score.
Measured: assessed at the end of the study (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start9 Oct 2024
- Primary completion30 Apr 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological RecoveryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility and acceptability study. A mixed methods design will be used to meet the aims of this study. The study will consist of two parts, firstly quantitative; quasi-experimental group comparison design and secondly a qualitative design with data collection based on focus groups and additional surveys being distributed to patients who participate. The independent variable will be membership of the comparison (DIALOG) or treatment (DIALOG+) group. The dependent variable will be scores on the DIALOG measure at the end of the intervention period.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476483
- Sponsor's protocol ID
- 187799
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be made openly available through the data repository at the University of Sheffield depending on the data sharing agreement with the Sheffield health and social care (SHSC).
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the DIALOG Outcome Measure and a Solution-Focused Intervention (DIALOG+) in a Rehabilitation Psychiatric Inpatient Setting: A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT06476483
- Acronym / sponsor ID
- 187799
- Conditions
- Psychological Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 26 Jun 2024 (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.
This study aims to understand if implementing DIALOG+ in an inpatient psychiatric rehabilitation setting is feasible (can the intervention be implemented) and acceptable (how the intervention is perceived by staff and patient participants). If the intervention is proven to be feasible and acceptable a larger-scale study may take place. This study has been developed in response to the trust-wide implementation of DIALOG outcome measures. DIALOG+ offers additional solution-focused and person-centred follow-up questions to the DIALOG questions and links to multidisciplinary team (MDT) discussions. It is hoped that the conversations had during DIALOG+ meetings will support positive outcomes, and the learning gathered from this study will drive change and improvement for other people requiring psychiatric rehabilitation inpatient admissions in the future. DIALOG+ has been successfully implemented in community settings in the national health service (NHS) but has not been implemented in psychiatric rehabilitation inpatient settings. This study will aim to recruit patient and staff participants from NHS psychiatric rehabilitation inpatient wards. Patient participants who will be eligible to take part are those who can consent, are between the ages of 18-65, and can complete DIALOG and DIALOG+. To understand the feasibility of the intervention, descriptive statistics will be collected and to understand acceptability focus groups will take place and surveys will be collected. Quantitative data collection will take place over 5 months and will be split into 2 groups. Group one will be a comparison group where participants will act as an extended baseline group and biweekly DIALOG outcomes will be collected. Group 2 will be a Treatment group and participants will receive the DIALOG+ intervention intervention, DIALOG outcomes will be collected biweekly as part of the intervention. Finally, there will be a period to gather qualitative feedback from patient participants using surveys, and from staff participants using focus groups or semi-structured interviews.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility and acceptability study. A mixed methods design will be used to meet the aims of this study. The study will consist of two parts, firstly quantitative; quasi-experimental group comparison design and secondly a qualitative design with data collection based on focus groups and additional surveys being distributed to patients who participate. The independent variable will be membership of the comparison (DIALOG) or treatment (DIALOG+) group. The dependent variable will be scores on the DIALOG measure at the end of the intervention period.
| Arm | Type | Receives |
|---|---|---|
| DIALOG | Other | Behavioral: DIALOGThis is the comparison group, they will complete the DIALOG measure biweekly for 5 months. DIALOG scores pre and post-intervention will be used in the analyses. |
| DIALOG+ | Active comparator | Behavioral: DIALOG+This is the treatment group. The participants in this group have agreed to participate in DIALOG+ and will receive the intervention biweekly for 10 sessions (5 months). Pre and post-intervention DIALOG scores will be used in the analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18-65
- Capacity to give informed consent as determined by the MDT and through following informed consent processes.
- Admitted into the inpatient ward
- Can complete DIALOG and DIALOG+
Key exclusion criteria (2 listed)
- No capacity to consent
- Insufficient command of the English language
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 |
|---|---|---|
| DIALOG+A person-centred and solution-focused intervention linked to the DIALOG outcome measure (a measure of patient experience and quality of life). | Behavioural | DIALOG+ |
| DIALOGAn outcome measure consisting of 11 questions, with 8 related to quality of life and 3 items on treatment satisfaction. Patients can rate their satisfaction on a 7-point scale for each of the 8 life domains and 3 treatment aspects, resulting in scores for both quality of life and treatment satisfaction. The DIALOG scale does not provide any guidance for patient and clinician interactions. | Behavioural | DIALOG |
Primary outcome
Feasibility outcome- Recruitment rate/consent rate
Time frame: assessed at the end of the study (after 5 months)
The number of people who agreed and consented to participate in the study out of the total number of eligible participants approached. Reported as a percentage.
Feasibility outcome- Number of eligible participants.
Time frame: assessed at the end of the study (after 5 months)
Eligible participants are those who meet the inclusion criteria, reported as a count of participants.
Feasibility outcome- Participation rate
Time frame: assessed at the end of the study (after 5 months)
The proportion of those who consented and agreed to engage in DIALOG and DIALOG+ out of the number of participants who engaged in the intervention after consenting. Reported as a percentage of participants.
Feasibility outcome- Completion rate
Time frame: assessed at the end of the study (after 5 months)
The proportion of those who completed the intervention out of the number who consented and engaged in DIALOG and DIALOG+. Reported as a percentage of participants.
Feasibility outcome- Drop out rate
Time frame: assessed at the end of the study (after 5 months)
The number of participants who completed the intervention out of total number of patients enrolled. Reported as a percentage of participants.
Feasibility outcomes- Reasons for drop out
Time frame: assessed at the end of the study (after 5 months)
Reasons for drop out will be assessed when by asking the participant after drop out.
Feasibility outcomes- Follow up rate
Time frame: assessed at the end of the study (after 5 months)
The number of patients willing to engage in follow-up surveys related to the study out of the total number of participants enrolled in the study. Reported as a percentage of participants.
Feasibility outcome- The willingness of clinicians to recruit participants
Time frame: assessed at the end of the study (after 5 months)
Number of staff members who attend DIALOG+ training and implement intervention out of the total number of staff offered to participate. Reported as a percentage.
Feasibility outcome- Average number of DIALOG+ sessions
Time frame: assessed at the end of the study (5 months)
Reported as the average number of participants.
Acceptability outcome- Cost
Time frame: assessed at the end of the study (after 5 months)
Analysing the cost and benefits of implementing the intervention (including staff training). Reported as a total amount or duration of time spent on training (minutes).
Number of staff participants who find DIALOG and DIALOG+ feasible and acceptable to implement in an inpatient rehabilitation setting. Assessed using thematic analysis of focus groups.
Time frame: assessed at the end of the study (after 5 months)
To assess the acceptability of the intervention a theoretical framework (Sekhon et al., 2017) was used. Feasibility objectives are defined by Bugge et al., 2013. Focus group transcripts will be subject to a qualitative thematic analysis. Analysis of focus groups will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview with in relation to the research question (Braun \& Clarke, 2006).
Number of patients who find it feasible and acceptable to implement DIALOG and DIALOG+ in an inpatient rehabilitation setting. Assessed using thematic analysis and average scores of patient surveys.
Time frame: assessed at the end of the study (after 5 months)
The questionnaires will be a mixture of open ended questions and Likert Scale questions based on questions asked by Matanov et al. (2021), 8 of the questions are scored on a Likert scale (1-5). The survey will be given to patients post-intervention. Questions on the scale have been specifically developed to assess feasibility and acceptability of DIALOG+. An average total score will be used in the analysis of Likert scale questions. Open-ended questionnaire responses will be subject to a qualitative thematic analysis. Analysis will involve coding, organising coding into themes, reviewing themes, and generating a final thematic overview in relation to the research question (Braun \& Clarke, 2006).
3 secondary outcomes
DIALOG questionnaire
Time frame: At the beginning of the study, then biweekly for a duration of 5 months with the final measure taken after 5 months
Demographic information
Time frame: assessed at the end of the study (5 months)
Length of admission in months
Time frame: assessed at the end of the study (5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Data may be made openly available through the data repository at the University of Sheffield depending on the data sharing agreement with the Sheffield health and social care (SHSC).
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIALOG+ and DIALOG in people with Psychological Recovery, run by University of Sheffield at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 13 Mar 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome- Recruitment rate/consent rate (time frame: assessed at the end of the study (after 5 months)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.