Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT03712332
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2018-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inpatient Distress Tolerance Group Intervention Pilot
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
A Transdiagnostic Group Intervention to Enhance Distress Tolerance: A Mixed Methods Pilot Evaluation in an Acute Inpatient Setting
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: