Clinical trial NCT03712332: Inpatient Distress Tolerance Group Intervention Pilot
Official title: A Transdiagnostic Group Intervention to Enhance Distress Tolerance: A Mixed Methods Pilot Evaluation in an Acute Inpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inpatients
Keywords: Distress tolerance
transdiagnostic
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lanarkshire
First posted: 2018-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability and Feasibility Qualitative Interview
timeFrame: Post Intervention (Start of week 5)
measure: Attendance/Attrition Rates
timeFrame: twice a week at each group session for up to three weeks
Secondary outcomes:
measure: Distress Tolerance Scale (Simons & Gaher, 2005)
timeFrame: 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)
measure: Computerised Mirror tracing persistence task (MTPT-C; Strong et al., 2003)
timeFrame: Pre intervention meeting (day 0) and Post intervention (usually start of week 5)
measure: Philadelphia Mindfulness Scale - acceptance subscale (PHLMS; Cardaciotto et al., 2008)
timeFrame: 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)
measure: The clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM, Evans et al., 2002).
timeFrame: Pre intervention (day 0) and post intervention (usually start of week 5)
measure: Clinical Outcomes in Routine Evaluation Questionnaire (CORE-10; Connell & Barkham, 2007).
timeFrame: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
measure: Personal Coping Questionnaire (PQ)
timeFrame: Pre intervention (day 0) and post intervention (usually start of week 5)
measure: Use of medication as required
timeFrame: Every day during baseline (days 1-7) and every day for up to three weeks during intervention (days 8-28)
Other outcomes:
Locations:
city: East Kilbride
country: United Kingdom
facility: Hairmyres Hospital
state: South Lanarkshire
Study officials:
affiliation: NHS Lanarkshire
name: Emma L Boyd
role: PRINCIPAL_INVESTIGATOR
References: