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What Have Been the Experiences of Female Survivors of Interpersonal Trauma on the Survive & Thrive Course (EoFSoITotS&TC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649867
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Lucie Bartoskova, NHS Tayside

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.

Condition or disease Intervention/treatment Phase
Interpersonal Trauma Other: Semi-structured interviews Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Qualitative Study - semi-structured interviews
Masking: None (Open Label)
Primary Purpose: Other
Official Title: What Have Been the Experiences of Female Survivors of Interpersonal Trauma on the Survive & Thrive Course
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Semi-structured interview
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
Each participant will attend a 30-45 minute semi-structured interview conducted by the CI




Primary Outcome Measures :
  1. Participants Experience of the Survive & Thrive Course - Themes [ Time Frame: 30-45 minutes ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- individuals in cohorts facilitated by the chief investigator


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649867


Locations
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United Kingdom
Dundee Adult Psychological Therapies Service
Dundee, Tayside, United Kingdom, DD3 6HH
Sponsors and Collaborators
NHS Tayside
Investigators
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Principal Investigator: Lucie Bartoskova, Dr NHS Tayside - Dundee Adult Psychological Therapies Service
  Study Documents (Full-Text)

Documents provided by Dr Lucie Bartoskova, NHS Tayside:

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Responsible Party: Dr Lucie Bartoskova, Counselling Psychologist, NHS Tayside
ClinicalTrials.gov Identifier: NCT03649867    
Other Study ID Numbers: 3-003-18
First Posted: August 28, 2018    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not applicable. Summary of anonymised quotes from the research study will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action