NCT03649867

Brief Summary

The study is aimed to explore female patients' experience of the Survive \& Thrive course that has been designed for survivors of interpersonal trauma (e.g. childhood sexual abuse, domestic abuse, rape, physical abuse, neglect, harassment, stalking and similar). The course aims to help attendees develop an understanding of the normal range of reactions to trauma and introduce new ways of coping. It is a 10 week course that is structured to utilise cognitive behavioural skills training while delivering psychoeducation on how a history of victimisation can impacts on the survivors life. Female adult participants who attended the Survive \& Thrive course will be invited to take part in a 30-45 minutes semi-structured interview exploring their experience of the course. The aim is to interview 12 participants; those individuals attended 6 or more sessions. Access to some demographic information will be gained through the Survive \& Thrive team to gain additional insight to the participant's course experience. The rationale for this study is to evaluate the effectiveness of the Survive \& Thrive course as a treatment option within the Stepped Care Approach for survivors of interpersonal trauma. There is an increasing number of individuals being exposed to traumatic life events. Most research has concentrated on the individual psychological input for patients with trauma history. Courtois and Ford (2009) argued that at a service level, group therapy is more efficient than individual as it can be offered more broadly. There is however limited research on the effectiveness of manualised approaches for the mental health and behavioural problems. Research shows that safety and stabilisation in trauma survivors can be achieved through psychoeducational approaches which emphasise present-time, coping strategies/skills, elimination of self-harming behaviour, control over acute symptoms, and increased self-care (Lubin \& Johnson, 1997). Findings from this study will be published.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 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

August 20, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

August 20, 2018

Results QC Date

November 18, 2019

Last Update Submit

January 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participants Experience of the Survive & Thrive Course - Themes

    Total of 13 participants attended 30 minutes semi-structured interview which explored their experience of the Survive \& Thrive course. The transcribed interviews were analysed using Interpretative Phenomenological Analysis (IPA). Superordinate themes captured by the interviews followed by respective sub-themes were: 1. Sense of connectedness, Sub-themes: I am not alone; Shared understanding; Safe environment/space 2. Journey towards recovery, Sub-themes: It gets harder before it gets better; Life changing experience; Sense of empowerment; Long way to go 3. Facing the facts \& triggers, Sub-themes: Facing denial \& triggers; Eye opening moments; Acceptance and greater understanding 4. Initial apprehension, Sub-themes: Sense of helplessness; Readiness for change; Fear of the unknown 5. Sense of being let down, Sub-themes: Challenging personalities; Repetitiveness of questionnaires; Need for additional support The number of participants that fell into each theme are reported below.

    30-45 minutes

Study Arms (1)

Semi-structured interview

OTHER

Each female patient who attended the Survive \& Thrive course designed for survivors of interpersonal trauma who meets the inclusion criteria will be invited to take part in a semi-structured interview. This interview will explore their experience of this psychoeducational course.

Other: Semi-structured interviews

Interventions

Each participant will attend a 30-45 minute semi-structured interview conducted by the CI

Semi-structured interview

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet Survive \& Thrive course criteria
  • adults between the ages of 18 - 65 years
  • able to consent
  • history of interpersonal trauma (childhood sexual abuse, domestic abuse, rape, physical abuse, neglect, harassment, stalking and similar).
  • attended 6 or more sessions of the course

You may not qualify if:

  • \- individuals in cohorts facilitated by the chief investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dundee Adult Psychological Therapies Service

Dundee, Tayside, DD3 6HH, United Kingdom

Location

Results Point of Contact

Title
Dr Lucie Bartoskova
Organization
NHS Tayside - Dundee Adult Psychological Therapies Service

Study Officials

  • Lucie Bartoskova, Dr

    NHS Tayside - Dundee Adult Psychological Therapies Service

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Qualitative Study - semi-structured interviews
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Counselling Psychologist

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 28, 2018

Study Start

October 17, 2018

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Not applicable. Summary of anonymised quotes from the research study will be published

Locations