NCT03712332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

October 16, 2018

Last Update Submit

April 27, 2021

Conditions

Keywords

Distress tolerancetransdiagnostic

Outcome Measures

Primary Outcomes (2)

  • Acceptability and Feasibility Qualitative Interview

    A semi-structured face to face interview to gather information about participants experiences of the intervention.

    Post Intervention (Start of week 5)

  • Attendance/Attrition Rates

    Attendance/attrition rates as a measure of how acceptable/feasible the intervention is to participants.

    twice a week at each group session for up to three weeks

Secondary Outcomes (7)

  • 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)

  • Computerised Mirror tracing persistence task (MTPT-C; Strong et al., 2003)

    Pre intervention meeting (day 0) and Post intervention (usually start of week 5)

  • 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)

  • 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)

  • 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)

  • +2 more secondary outcomes

Study Arms (1)

Distress Tolerance Group

EXPERIMENTAL

6 session inpatient distress tolerance group intervention twice a week for 1.5 hours for up to three weeks.

Behavioral: Distress Tolerance Group

Interventions

The intervention is a distress tolerance skills-based group informed by mindfulness and acceptance principles and dialectical behavioural therapy (DBT).

Distress Tolerance Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hairmyres Hospital

East Kilbride, South Lanarkshire, G75 8RG, United Kingdom

Location

Study Officials

  • Emma L Boyd

    NHS Lanarkshire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 19, 2018

Study Start

February 18, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations