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Interpersonal TraumaEoFSoITotS&TCNCT03649867

What Have Been the Experiences of Female Survivors of Interpersonal Trauma on the Survive & Thrive Course

A study testing Semi-structured interviews in people with Interpersonal Trauma, run by NHS Tayside at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Interpersonal Trauma
What is being tested?
Semi-structured interviews
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited Kingdom
Study dates
17 Oct 2018to 30 Jan 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • individuals in cohorts facilitated by the chief investigator

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Dundee Adult Psychological Therapies Service

    Dundee, Tayside, DD3 6HH

Other trials in United Kingdom

About this study

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.

Read the detailed description

Design The proposed research is a qualitative study using a purposive sample (participants have a position of shared experience), consisting of semi-structured interviews and some demographic information will be collected from the Survive \& Thrive database.

Procedures All the procedures planned for this research project have been considered in detail to ensure that they follow the highest standards in the BPS (2009) ethical guidelines and the Health \& Care Professions Council (HCPC, 2012) standards of proficiency. Initially, the Survive \& Thrive database will be screened by the Survive \& Thrive course team for female patients who have attended any 6 or more sessions out of the 10. These sessions are not required to be consecutive. Each session co-facilitators record attendance that is then stored on the Survive \& Thrive SMF. They will be sent a letter informing them of this study along with a participants' information sheet and a reply slip passing on their note of interest to be contacted by the CI about the study (please see attached documents). This letter will be sent by the Survive \& Thrive team leader who was in prior contact with the patients and her name has been on prior correspondence with them. It will provide them with space to specify their preferred method of contact. A pre-paid envelope addressed to the CI will be provided. Once reply slip is received, I will contact them to offer further information about the study and arrange to meet with them to complete the consent form and to conduct the semi-structured interview. Please see attached forms that will be sent out to potential participants.

Additionally, co-facilitators will inform current patients about this study at the beginning of week 6 of the Survive \& Thrive course and hand out the information sheet and reply slip. At the beginning of week 7, co-facilitators will ask patients to pass on the reply slip if they would like to be contacted by the CI to find out more about the study. The co-facilitators will be provided with an additional form that they will complete along with the attendance sheet (please see attached). This form will enable monitoring of who was informed of the study and who has agreed to be contacted in relation to it. All of the entries in this form will be initialled and dated by the Survive \& Thrive co-facilitators. The CI will not have access to these forms and will only be provided with information \& contact numbers for individuals who have shown interest in the study and agreed to be contacted in relation to it. When the CI contacts potential participants (upon receiving a reply slip) who have shown interest, it will be specified that the interview will be arranged after the 10th week of the course (once the course is completed). The potential participants had to attend during this time any 6 sessions or more of the 10 (not required to be consecutive).

If they agree to be contacted regarding this study, the CI will then contact them. The CI will provide them with additional information regarding the study that is detailed in the participant information sheet. Participants will be assured that all data is stored securely and confidentially. The demographic data will be given a code along with the interview transcript to match the two data sets.

Once the participants agree to take part, arrangements to meet at one of the clinical rooms will be made. At this point they will confirm their consent to participate in the study by signing the consent form. After they sign the consent form they will take part in the semi-structured interview. Lastly, the participants will take part in a brief off-tape discussion regarding their experience of the interview and thanked for their participation. A list of contact recommendations of who to contact if participants became distressed or would like further support/opportunity to speak about the topics discussed during the interview will be provided to them at the end of the interview.

Material Semi-structured interviews will be conducted. The choice of questions considered how best to reflect the chosen data analysis in IPA that is entirely concerned with understanding individuals' experiences, feelings, and meaning-making. Thus, the selected questions are concentrated on emotions, values, and priorities.

Methods of analysis The proposed method of analysis for this research project is Interpretative Phenomenological Analysis (IPA), a method that has particular resonance for psychologists within qualitative research. It offers an established, systematic, and phenomenologically-focused approach to the interpretation of first-person accounts. It is a meaning-focused qualitative method that is committed to the understanding of the first-person perspective of their experience from the third-person position through inter-subjective inquiry and analysis.

Analysis of the data gathered will begin with transcribing the twelve 30-45minutes semi-structured interviews (by the Service admin staff who types up clinical letters). A decision to use the NHS admin staff for transcribing of the interviews was made due to a time restriction on this research and to ensure for confidentiality of the data. This will provide some time security as well as ensuring that the transcript will be to the highest standard. Once the interviews are transcribed, the audio recording will be deleted. I will then start familiarising myself with the transcriptions. This will be followed by a cyclical process of synthesis and analysis which will involve the reading and re-reading of the transcripts followed by exploratory manual coding (no use of software) of anything of interest within the transcript that allows me to identify the specific ways each participant talks about, thinks about and understands their experience. This step is followed by identifying the emerging themes throughout the transcripts. Once these are identified I will draw a map of the emerging themes to provide a structure for writing up the information and clustering all the themes that are repeated.

Once this is completed I will go back over the gained information and start making sense of the data by connecting patterns and making connections between recurrent themes by looking at, for example, how these recurrent themes inter-relate. I will attempt to conceptualise the connections and patterns and use this to organise the data, and draw relationships between them. The production of a summary table is seen as a beneficial next step to gain a clear and systematic overview of thematic clusters, together with keywords and the locations of relevant quotations. Afterwards the interpretative part of the IPA, that has recently been divided into two distinct levels, begins. The first level is a more descriptive, empathic level, aiming to enter the participants' world, while the second level is seen as more critically interrogative of the participants' views, in order to gain further insight into their nature, meaning and origins. I will aim to draw predominantly on the first level of interpretation of the data as the second has received some ethical criticism around the imposition of meaning upon data.

Once writing up the findings some example quotations will be used to represent recurrent themes, to offer readers an insight into the survivors of interpersonal trauma who attended Survive \& Thrive course thinking patterns. Excel (Microsoft office) program will then be used to conduct how many themes occur across how many participants.

Being tested
Semi-structured interviews

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-structured interviewsOther

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

Study groups in NCT03649867
Study groupRoleWhat they receive
Semi-structured interviewOtherEach 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.
Receives: Other: Semi-structured interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30-45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start17 Oct 2018
  3. Primary completion30 Jan 2019
  4. Study completion30 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Qualitative Study - semi-structured interviews
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649867
Sponsor's protocol ID
3-003-18
Acronym
EoFSoITotS&TC
Status last verified
Jan 2020
First submitted
20 Aug 2018
Last updated
18 Jan 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not applicable. Summary of anonymised quotes from the research study will be published

Questions about this trial

What is this clinical trial studying?

A study testing Semi-structured interviews in people with Interpersonal Trauma, run by NHS Tayside at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Experience of the Survive & Thrive Course - Themes (time frame: 30-45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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