InpatientsNCT03712332
Inpatient Distress Tolerance Group Intervention Pilot
A study testing Distress Tolerance Group in people with Inpatients, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Research suggests that a low capacity to tolerate distress is a common underlying factor in the development and maintenance of a range of mental health problems. This study aims to pilot a mindfulness-based distress tolerance (DT) group intervention in an acute inpatient setting to assess the acceptability and… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inpatients
- What is being tested?
- Distress Tolerance Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2019to 31 Dec 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current in-patient in the specific psychiatric ward in which the research is taking place
- Speak sufficient English to participate in talking therapy
Who cannot join
- Participants who are participating in any other current intervention research
- Participants who do not have the capacity to consent, including participants who have a significant cognitive deficit that would make it difficult for them to engage with the group material (e.g. dementia or learning disability)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hairmyres Hospital
East Kilbride, South Lanarkshire, G75 8RG
About this study
Official title: A Transdiagnostic Group Intervention to Enhance Distress Tolerance: A Mixed Methods Pilot Evaluation in an Acute Inpatient Setting
Research suggests that a low capacity to tolerate distress is a common underlying factor in the development and maintenance of a range of mental health problems. This study aims to pilot a mindfulness-based distress tolerance (DT) group intervention in an acute inpatient setting to assess the acceptability and feasibility of the intervention for both staff facilitating and patients receiving the intervention. The study also aims to explore if the proposed intervention can help improve DT through developing mindful acceptance of emotions.
Read the detailed description
Research has identified distress tolerance (DT) as a risk factor in the development and maintenance of various mental health problems, including anxiety, traumatic stress, depression, substance use disorders, psychosis, borderline personality disorder, and eating disorders. This research suggests that people with a poor ability to tolerate distress may use a range of unhelpful coping strategies such as experiential avoidance, which has been strongly associated with a range of mental health difficulties.
A small, but growing body of research has shown improvements in DT using mindfulness and acceptance-based interventions, and reductions in distress and avoidant behaviours associated with low DT. It has been suggested that mindfulness and acceptance-based strategies increase DT through repeated exposure to distressing emotions and practice of non-judgemental observation and acceptance of distressing emotions without trying to escape them. The current study proposes to deliver a mindfulness and acceptance based DT Skills intervention group program informed by dialectical behavioural therapy (DBT).
Due to the lack of published research examining the effectiveness of a distress tolerance group intervention in this setting, and the limited research exploring the mechanisms and process of change, it was decided that the primary research question should explore the acceptability and feasibility of the intervention in the first instance, and examine a theorised mechanism of change, as well as the process of change as secondary research questions in order to provide a foundation for further research in this area.
Primary Objective
To explore the acceptability and feasibility of a transdiagnostic DT intervention in an inpatient setting using a mixed methods case series design.
Secondary Objectives
Examine whether the intervention improves acceptance of negative emotional states and perceived and behavioural capacity to tolerate distress. It is hypothesised that over the course of treatment, as acceptance of negative emotional experiences increases, perceived and behavioural capacity to tolerate distress will also improve in line with this.
To explore the use of multi-level modelling to examine the process of change in the proposed intervention.
- Conditions
- Inpatients
- Being tested
- Distress Tolerance Group
- Keywords
- Distress tolerance, transdiagnostic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress Tolerance GroupBehavioural
The intervention is a distress tolerance skills-based group informed by mindfulness and acceptance principles and dialectical behavioural therapy (DBT).
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance Group | Experimental | 6 session inpatient distress tolerance group intervention twice a week for 1.5 hours for up to three weeks. Receives: Behavioral: Distress Tolerance Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and Feasibility Qualitative Interview
A semi-structured face to face interview to gather information about participants experiences of the intervention.
Measured: Post Intervention (Start of week 5)
Attendance/Attrition Rates
Attendance/attrition rates as a measure of how acceptable/feasible the intervention is to participants.
Measured: twice a week at each group session for up to three weeks
Secondary outcomes (7)
Distress Tolerance Scale (Simons & Gaher, 2005)
Assesses perceived ability to cope with unpleasant emotional states. 15 items and responses are measured on a 5-point likert scale ranging from (1) strongly agree to (5) strongly disagree.
Measured: Pre-intervention (day 0), every day during baseline (days 1-7), every day for up to three weeks during intervention (days 8-28), and post-intervention (Start of week 5)
Computerised Mirror tracing persistence task (MTPT-C; Strong et al., 2003)
The MTPT-C is a computerised version of the MTPT (Quinn et al., 1996) which is a task commonly used to measure behavioural capacity to tolerate distress. The MTPT-C requires the participant to move a red dot along the outline of a star shown on the monitor with their computer mouse. Moving the computer mouse up and to the right will result in the dot moving down and to the left, thus the task simulates the experience of tracing a star as viewed in a mirror. Each time the dot comes out with the outline of the star, a buzzer will sound. There are usually two practice trials to allow participants to orient to the task and three trials lasting 5 minutes each, with each trial becoming increasingly difficult, if not impossible to trace within the line (Daughters et al., 2005). During the final and most challenging trial, participants are given the option to quit by pressing the spacebar at any time. Distress tolerance is measured by time to task termination on the third shape.
Measured: Pre intervention meeting (day 0) and Post intervention (usually start of week 5)
Philadelphia Mindfulness Scale - acceptance subscale (PHLMS; Cardaciotto et al., 2008)
The PHLMS is a 20-item measure to assess two components of mindfulness: present-moment awareness and acceptance of the present state. Responses are measured on a 5-point likert scale ranging from (1) never to (5) very often. Higher scores on each subscale reflect higher levels of awareness and acceptance.
Measured: Pre-intervention (day 0), every day during baseline (days 1-7), every day for up to three weeks during intervention (days 8-28), and post-intervention (Start of week 5)
The clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM, Evans et al., 2002).
The CORE-OM is a 34- item global measure of distress comprised of four subscales that assess for: symptoms, subjective wellbeing, functioning, and risk. Responses are measured on a 5-point likert scale ranging from (0) not at all to (4) most or all of the time. Higher scores indicate higher levels of psychological distress.
Measured: Pre intervention (day 0) and post intervention (usually start of week 5)
Clinical Outcomes in Routine Evaluation Questionnaire (CORE-10; Connell & Barkham, 2007).
A brief version consisting of 10 items that have been drawn from the CORE-OM. The CORE-10 is routinely used in clinical settings as a global measure of distress and assesses for symptoms, subjective wellbeing, functioning, and risk. Responses are measured on a 5-point likert scale ranging from (0) not at all to (4) most or all of the time. Higher scores indicate higher levels of psychological distress.
Measured: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
Personal Coping Questionnaire (PQ)
The PQ will be a participant generated list that corresponds to how the participant currently copes when distressed. This list will be generated by asking the participant "what do you do to cope when you are feeling distressed?" The list may include adaptive and maladaptive coping strategies. The participant will then be asked to rate how often they have used each strategy over the last week on a scale of (1) not at all to 5 (every day).
Measured: Pre intervention (day 0) and post intervention (usually start of week 5)
Use of medication as required
The use of 'medication as required' will be used as a daily behavioural measure of coping. A baseline will be established and then the frequency of 'medication as required' use will be gathered from casenotes throughout the intervention phase.
Measured: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start18 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InpatientsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A basic two-phase AB case series design will be used. All participants will complete a seven day baseline phase, followed by the intervention phase of up to three weeks.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lanarkshire
- Responsible party
- Sponsor
- Investigators
- Emma L Boyd, Principal investigator, NHS Lanarkshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712332
- Sponsor's protocol ID
- CAHSS1808/04
- Status last verified
- Apr 2021
- First submitted
- 16 Oct 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Group Intervention to Enhance Distress Tolerance: A Mixed Methods Pilot Evaluation in an Acute Inpatient Setting
- ClinicalTrials.gov ID
- NCT03712332
- Acronym / sponsor ID
- CAHSS1808/04
- Conditions
- Inpatients
- Keywords
- Distress tolerance, transdiagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lanarkshire
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Oct 2018 (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.
Research suggests that a low capacity to tolerate distress is a common underlying factor in the development and maintenance of a range of mental health problems. This study aims to pilot a mindfulness-based distress tolerance (DT) group intervention in an acute inpatient setting to assess the acceptability and feasibility of the intervention for both staff facilitating and patients receiving the intervention. The study also aims to explore if the proposed intervention can help improve DT through developing mindful acceptance of emotions.
Detailed description
Research has identified distress tolerance (DT) as a risk factor in the development and maintenance of various mental health problems, including anxiety, traumatic stress, depression, substance use disorders, psychosis, borderline personality disorder, and eating disorders. This research suggests that people with a poor ability to tolerate distress may use a range of unhelpful coping strategies such as experiential avoidance, which has been strongly associated with a range of mental health difficulties.
A small, but growing body of research has shown improvements in DT using mindfulness and acceptance-based interventions, and reductions in distress and avoidant behaviours associated with low DT. It has been suggested that mindfulness and acceptance-based strategies increase DT through repeated exposure to distressing emotions and practice of non-judgemental observation and acceptance of distressing emotions without trying to escape them. The current study proposes to deliver a mindfulness and acceptance based DT Skills intervention group program informed by dialectical behavioural therapy (DBT).
Due to the lack of published research examining the effectiveness of a distress tolerance group intervention in this setting, and the limited research exploring the mechanisms and process of change, it was decided that the primary research question should explore the acceptability and feasibility of the intervention in the first instance, and examine a theorised mechanism of change, as well as the process of change as secondary research questions in order to provide a foundation for further research in this area.
Primary Objective
To explore the acceptability and feasibility of a transdiagnostic DT intervention in an inpatient setting using a mixed methods case series design.
Secondary Objectives
Examine whether the intervention improves acceptance of negative emotional states and perceived and behavioural capacity to tolerate distress. It is hypothesised that over the course of treatment, as acceptance of negative emotional experiences increases, perceived and behavioural capacity to tolerate distress will also improve in line with this.
To explore the use of multi-level modelling to examine the process of change in the proposed intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A basic two-phase AB case series design will be used. All participants will complete a seven day baseline phase, followed by the intervention phase of up to three weeks.
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance Group | Experimental | Behavioral: Distress Tolerance Group6 session inpatient distress tolerance group intervention twice a week for 1.5 hours for up to three weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current in-patient in the specific psychiatric ward in which the research is taking place
- Speak sufficient English to participate in talking therapy
Key exclusion criteria (2 listed)
- Participants who are participating in any other current intervention research
- Participants who do not have the capacity to consent, including participants who have a significant cognitive deficit that would make it difficult for them to engage with the group material (e.g. dementia or learning disability)
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 |
|---|---|---|
| Distress Tolerance GroupThe intervention is a distress tolerance skills-based group informed by mindfulness and acceptance principles and dialectical behavioural therapy (DBT). | Behavioural | Distress Tolerance Group |
Primary outcome
Acceptability and Feasibility Qualitative Interview
Time frame: Post Intervention (Start of week 5)
A semi-structured face to face interview to gather information about participants experiences of the intervention.
Attendance/Attrition Rates
Time frame: twice a week at each group session for up to three weeks
Attendance/attrition rates as a measure of how acceptable/feasible the intervention is to participants.
7 secondary outcomes
Distress Tolerance Scale (Simons & Gaher, 2005)
Time frame: Pre-intervention (day 0), every day during baseline (days 1-7), every day for up to three weeks during intervention (days 8-28), and post-intervention (Start of week 5)
Computerised Mirror tracing persistence task (MTPT-C; Strong et al., 2003)
Time frame: Pre intervention meeting (day 0) and Post intervention (usually start of week 5)
Philadelphia Mindfulness Scale - acceptance subscale (PHLMS; Cardaciotto et al., 2008)
Time frame: Pre-intervention (day 0), every day during baseline (days 1-7), every day for up to three weeks during intervention (days 8-28), and post-intervention (Start of week 5)
The clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM, Evans et al., 2002).
Time frame: Pre intervention (day 0) and post intervention (usually start of week 5)
Clinical Outcomes in Routine Evaluation Questionnaire (CORE-10; Connell & Barkham, 2007).
Time frame: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
Personal Coping Questionnaire (PQ)
Time frame: Pre intervention (day 0) and post intervention (usually start of week 5)
Use of medication as required
Time frame: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
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 28 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Emma L Boyd principal investigator
NHS Lanarkshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distress Tolerance Group in people with Inpatients, run by University of Edinburgh 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 2 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 28 Apr 2021. 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?
Acceptability and Feasibility Qualitative Interview (time frame: Post Intervention (Start of week 5)). 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?
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 28 Apr 2021; AzTrials last refreshed its copy on 1 Nov 2026.