NCT02413307

Brief Summary

\*\*PLEASE NOTE\*\* this study is currently open only to clients on the waiting list at the Centre for Trauma Resilience and Growth, UK. The project will involve adapting and implementing a five minute daily self-practice compassion-focused intervention and evaluate its impact on psychological and physiological factors associated with trauma. It aims to offer a novel intervention which may facilitate further benefits from trauma specific therapy. This would be a unique use of self-practice Compassion Focused Therapy (CFT) specifically for trauma clients. Previous research has found that many factors can impact on client's benefitting from therapy, including depression, anxiety and self-criticism. These things also get in the way of being compassionate towards oneself, and this can be a difficulty for people who have experienced traumatic events. Service users have identified that additional support before trauma specific therapy can be useful and this may offer a positive use of time whilst on therapy waiting lists. Hypotheses: i. A brief CFT intervention will decrease levels of depression, anxiety, stress and increase baseline Heart Rate Variability. ii. The compassion focused intervention will increase experiences of self-compassion, social safeness, and reduce levels of self-criticism. iii. High 'fear of compassion' will moderate the impact of the intervention and result in smaller changes in depression, anxiety, stress and post traumatic change. Clients of the Centre for trauma, resilience and growth will be approached to participate in the study. All participants will have experienced trauma for which they are seeking psychological support. The current compassion focused intervention will be offered to participants on the waiting list for trauma specific therapy at the trauma centre. Each participant will be asked to practice the intervention in their own time over a period of three weeks. There will be initial assessments, repeated assessments following the intervention, and repeated assessments pre and post trauma specific therapies engaged in.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 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

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

April 6, 2015

Last Update Submit

October 18, 2017

Conditions

Keywords

Compassion Focused Therapy

Outcome Measures

Primary Outcomes (1)

  • Depression Anxiety and Stress Scales (DASS-21)

    21-item version. Self-report measuring negative emotional states of depression, anxiety and stress

    up to six weeks

Secondary Outcomes (7)

  • Heart Rate Variability (HRV)

    three weeks, six weeks

  • Self-Compassion Scale (SCS)

    three weeks, six weeks

  • Fears of Compassion Scale (FOC) Scale 3: Expressing kindness and compassion towards yourself.

    three weeks, six weeks

  • The Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCRS)

    three weeks, six weeks

  • Social Safeness and Pleasure Scale (SSPS)

    three weeks, six weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Self-practice compassion focused therapy intervention following written or audio scripts. This includes instructions, an explanation of compassion and aims of the intervention. It includes several exercises designed to increase self-compassion including breathing exercises and compassionate imagery exercises focused on self and others

Other: Compassion Focused Therapy (self-practice)

Waiting List Control

NO INTERVENTION

Participants on the waiting list for trauma specific therapy. These will be participants who have consented to engaging in the research project but their intervention phase has a delayed start.

Interventions

Daily practice of the CFT exercises for a minimum of five minutes per day. This is completed for a period of three weeks.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand verbal and written English language (due to resources, the adapted intervention will not be translated);
  • \*\*\*To be on the waiting list for therapy at the Centre for Trauma Resilience and Growth, Nottingham UK\*\*\*;
  • Able to access a computer, CD player or mp3 file;
  • Had experience of a traumatic event

You may not qualify if:

  • participants involved in the pilot phase of the project
  • unable to understand verbal and written English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lincoln

Lincoln, LN6 7TS, United Kingdom

Location

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Claire Rycroft

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

February 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Currently no plans to share IPD. If researchers wish to view data analysis following the study they can contact the researcher.

Locations