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Clinical Trials/NCT03712332
NCT03712332CompletedNot Applicable

A Transdiagnostic Group Intervention to Enhance Distress Tolerance: A Mixed Methods Pilot Evaluation in an Acute Inpatient Setting

University of Edinburgh2 sites in 1 country21 target enrollmentStarted: February 18, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
2
Primary Endpoint
Acceptability and Feasibility Qualitative Interview

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Current in-patient in the specific psychiatric ward in which the research is taking place
  • Speak sufficient English to participate in talking therapy

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Distress Tolerance Scale (Simons & Gaher, 2005)(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))
  • Personal Coping Questionnaire (PQ)(Pre intervention (day 0) and post intervention (usually start of week 5))
  • Use of medication as required(Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28))
  • Clinical Outcomes in Routine Evaluation Questionnaire (CORE-10; Connell & Barkham, 2007).(Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28))
  • Philadelphia Mindfulness Scale - acceptance subscale (PHLMS; Cardaciotto et al., 2008)(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)(Pre intervention meeting (day 0) and Post intervention (usually start of week 5))
  • The clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM, Evans et al., 2002).(Pre intervention (day 0) and post intervention (usually start of week 5))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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