Effects of online complex post-traumatic stress disorder treatment in women survivors of intimate partner violence with post-traumatic stress disorder

ISRCTN	ISRCTN99438057
DOI	https://doi.org/10.1186/ISRCTN99438057
Secondary identifying numbers	PID2019-110041GB-I00

Submission date: 19/03/2021
Registration date: 07/04/2021
Last edited: 21/07/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Intimate partner violence is where one person in a relationship attempts to control the other through threats, acts of physical, sexual, verbal or psychological violence. As a result of this type of violence, women survivors are at greater risk of suffering both psychological and physical health problems. One of the main problems for women who have suffered this violence is post-traumatic stress disorder (PTSD). However, the PTSD diagnosis does not adequately and totally explain the negative psychological impact experienced by victims of interpersonal trauma, and the World Health Organization (WHO) proposes a new diagnosis of complex post-traumatic stress disorder (complex PTSD), which relates to the appearance of symptoms of affective (emotion) regulation problems, negative self-concept and difficulties in maintaining relationships with others. The aim of this study is to test a specific treatment for complex PTSD in female victims and survivors of intimate partner violence.

Who can participate?
Women survivors of intimate partner violence aged 18-65 with a diagnosis of complex PTSD

What does the study involve?
Women survivors of intimate partner violence are assessed for PTSD (classic symptoms and complex symptoms). Of these, women with complex PTSD symptoms will be randomly assigned to a control group who will receive a classic PTSD intervention or an intervention group who will receive a complex PTSD intervention. Both interventions will be online and will be applied in small groups. Each session lasts around 60-90 minutes and the whole intervention has 12 sessions. Once the intervention is completed, each participant receives €50.

What are the possible benefits and risks of participating?
Complex PTSD treatment may improve the symptoms of both classic PTSD and complex PTSD. Participants may experience some emotional discomfort when answering certain questions in the violence assessment questionnaires. They can choose to stop answering the questions and contact the researchers.

Where is the study run from?
University of Granada (Spain)

When is the study starting and how long is it expected to run for?
November 2019 to December 2024

Who is funding the study?
Ministry of Science, Innovation and Universities (Spain)

Who is the main contact?
1. BELIEVE Project (proyecto.believe21@gmail.com)
2. Prof. Natalia Hidalgo-Ruzzante (nhidalgo@ugr.es)
3. Prof. Miguel Pérez-García (mperezg@ugr.es)
4. Julia Daugherty, PhD (juliadaugherty1@gmail.com)
5. Carmen Fernández Fillol (carmenffillol@ugr.es)
6. Charitini Pitsiakou (charitinipitsiakou@gmail.com)

Study website

Contact information

Dr Natalia Hidalgo-Ruzzante
Scientific

Facultad de Ciencias de la Educación
Campus Universitario de la Cartuja, s/n
Granada
18071
Spain

ORCID ID	0000-0002-9952-9478
Phone	+34 (0)958243969
Email	nhidalgo@ugr.es

Mrs Carmen Fernández-Fillol
Public

CIMCYC
Campus Universitario de la Cartuja, s/n
Granada
18071
Sudan

Phone	+249 (0)958245168
Email	carmenffillol@ugr.es

Study information

Study design	Two-group parallel blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Treatment
Participant information sheet	39661_PIS.pdf
Scientific title	Effects of online complex post-traumatic stress disorder treatment in women survivors of intimate partner violence with post-traumatic stress disorder (PTSD) on their symptomatology of classic PTSD and complex PTSD
Study acronym	SUPERTEPTCOM
Study objectives	Women survivors of intimate partner violence with complex PTSD who receive a specific treatment for complex PTSD, will improve their symptomatology of classic PTSD as well as their symptomatology of Complex PTSD. Women survivors of intimate partner violence with complex PTSD who receive a classic treatment for PTSD, will improve their symptomatology of classic PTSD but not their symptomatology of complex PTSD.
Ethics approval(s)	Approved 09/02/2020, Ethics Committee on Human Research (CEIH), University of Granada (Vicerrectorado de Investigación y Transferencia, Gran Vía nº 48, 2ª planta. 18071, Granada, Spain; +34 (0)958 243008; investigacion@ugr.es), ref: 975/CEIH/2019
Health condition(s) or problem(s) studied	Complex PTSD in women survivors of intimate partner violence
Intervention	Current interventions as of 14/07/2022: The intervention will be applied in a group format, online, consisting of 24 sessions. The sample will be composed of 60 women who have suffered IPV and also have been diagnosed with a Complex Post-traumatic Stress Disorder (C-PTSD) according to the ICD-11 diagnosis. Participants will reside in Spain and attend Women's Centers of different Women's Institutes or Associations of female IPV victims. Participants will be screened for the eligibility criteria in a presential or online interview. This includes a specific assessment regarding violence, education level, mental health and hospitalizations, and PTSD/C-PTSD diagnosis (60/90 minutes). Participants will be randomly allocated to two online interventions. A member of the research team not involved in the assessment or intervention will randomly allocate participants to the intervention (C-PTSD treatment) or control (PTSD treatment) group. The randomization list will be generated online using a web-based randomization tool. The number will be placed in an opaque envelope which is given to the Researcher who assigns the intervention (C-PTSD treatment) or control (PTSD treatment) program to each participant. The intervention group (C-PTSD treatment) receives the Skills Training in Affective and Interpersonal Regulation plus Modified Prolonged Exposure (STAIR/MPE) (adapted from Levitt y Cloitre, 2005; Cloitre, 2020), which consists of two phases. This Complex PTSD intervention will be implemented over 24 sessions delivered in 24 weeks. The control group (PTSD treatment) will receive an adaptation of the cognitive-behavioural Treatment for Posttraumatic Stress Disorder (PTSD) (adapted from Resick, Monson, Chard, 2017). It is a treatment that is widely used to recover from traditional symptomatology associated with PTSD. This PTSD treatment will be implemented over 24 sessions delivered during 24 weeks. In both treatments, the Guidelines for online intervention of Weiss, Azevedo, Webb, Gimeno, and Cloitre (2018) will be followed. Also, each treatment integrates skills in a way that is organized for and adapted to meet the needs of the women survivors of intimate partner violence. _____ Previous interventions: The intervention will be applied in a group format, online, consisting of 12 sessions. The sample will be composed of 60 women who have suffered IPV and also have been diagnosed with a Complex Post-traumatic Stress Disorder (C-PTSD) according to the ICD-11 diagnosis. Participants will reside in Spain and attend Women's Centers of different Women's Institutes or Associations of female IPV victims. Participants will be screened for the eligibility criteria in a presential or online interview. This includes a specific assessment regarding violence, education level, mental health and hospitalizations, and PTSD/C-PTSD diagnosis (60/90 minutes). Participants will be randomly allocated to two online interventions. A member of the research team not involved in the assessment or intervention will randomly allocate participants to the intervention (C-PTSD treatment) or control (PTSD treatment) group. The randomization list will be generated online using a web-based randomization tool. The number will be placed in an opaque envelope which is given to the Researcher who assigns the intervention (C-PTSD treatment) or control (PTSD treatment) program to each participant. The intervention group (C-PTSD treatment) receives the Skills Training in Affective and Interpersonal Regulation plus Modified Prolonged Exposure (STAIR/MPE) (adapted from Levitt y Cloitre, 2005; Cloitre, 2020), which consists of two phases. This Complex PTSD intervention will be implemented over 12 sessions delivered in 12 weeks. The control group (PTSD treatment) will receive an adaptation of the cognitive-behavioural Treatment for Posttraumatic Stress Disorder (PTSD) (adapted from Resick, Monson, Chard, 2017). It is a treatment that is widely used to recover from traditional symptomatology associated with PTSD. This PTSD treatment will be implemented over 12 sessions delivered during 12 weeks. In both treatments, the Guidelines for online intervention of Weiss, Azevedo, Webb, Gimeno, and Cloitre (2018) will be followed. Also, each treatment integrates skills in a way that is organized for and adapted to meet the needs of the women survivors of intimate partner violence.
Intervention type	Behavioural
Primary outcome measure	Current primary outcome measure as of 14/07/2022: 1. Symptoms of PTSD measured using the Escala de Gravedad de Síntomas del Trastorno de Estrés Postraumático según el DSM-5: versión forense (EGS-F) at baseline, session 4, session 8, session 12, session 18, session 24, and 6 months follow-up 2. Symptoms of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ) at baseline, 3 months and 6 months follow-up _____ Previous primary outcome measure: 1. Symptoms of PTSD measured using the Escala de Gravedad de Síntomas del Trastorno de Estrés Postraumático según el DSM-5: versión forense (EGS-F) at baseline, session 4, session 8, session 12, and 6 months follow-up 2. Symptoms of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ) at baseline, 3 months and 6 months follow-up
Secondary outcome measures	1. Sociodemographic characteristics measured using a survey with questions developed by the study team at baseline 2. Exposure to violence measured using a survey with questions developed by the study team at baseline, 3 months and 6 months follow-up 3. Intimate partner violence experiences measured using the Composite Abuse Scale (Revised)-Short Form (CASR-SF) at baseline, 3 months and 6 months follow-up 4. Resilience measured using the Connor‐Davidson resilience scale (CD‐RISC) at baseline, 3 months and 6 months follow-up. 5. Emotion regulation measured using the Emotion regulation questionnaire (ERQ) at baseline, session 4, session 8, session 12, and 6 months follow-up. 6. Negative self-perception measured using the Rosenberg self-esteem scale (RSE) at baseline, session 4, session 8, session 12, and 6-months follow-up 7. Difficulty with relationships and social isolation measured using the Revised UCLA Loneliness Scale at baseline, session 4, session 8, session 12, and 6-months follow-up 8. Perceived change measured using the Perceived Change Index at the end of each session 9. Retention rates assessed as the number of participants who consent to participate that remain in the trial by 3- and 6-month follow-up
Overall study start date	01/11/2019
Completion date	31/12/2024

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	60
Key inclusion criteria	1. Women who have experienced violence (exclusively psychological or psychological and physical) perpetrated by their partners/ex-partners 2. At least 18 years old 3. Diagnosed with complex Post-traumatic Stress Disorder (C-PTSD) according to ICD-11 criteria
Key exclusion criteria	1. Illiteracy 2. Difficulties in completing written tests 3. Altered mental state 4. Requiring recent admission to hospital or intensive treatment for a psychological disorder
Date of first enrolment	01/03/2020
Date of final enrolment	31/12/2023

Locations

Countries of recruitment

Spain

Study participating centre

The Mind, Brain and Behavior Research Center

Campus Universitario de Cartuja
Granada
18011
Spain

Sponsor information

Ministry of Science, Innovation and Universities (Spain)
Government

Calle Torrelaguna 58
Madrid
28027
Spain

Phone	+34 (0)912 582 852
Email	secretaria.general@aei.gob.es
Website	https://www.ciencia.gob.es/portal/site/MICINN/?lang_choosen=en

Funders

Funder type

Government

Ministerio de Ciencia, Innovación y Universidades

No information available

Results and Publications

Intention to publish date	30/03/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in high-impact peer-review journals about trauma, psychology and intimate partner violence. Other outputs will be the final study report; conference presentations; publication of a manual; a synopsis of findings to participants and experts-by-experience groups. In addition, the status of the project and the results will be disseminated on the following websites: the BELIEVE project (http://projectbelieve.info/), International Trauma Consortium (ITC, https://www.traumameasuresglobal.com/) and G-Stress Project (https://www.global-psychotrauma.net/g-stress).
IPD sharing plan	The datasets generated during the current study will be available upon request from Dr Natalia Hidalgo Ruzzante (nhidalgo@ugr.es) following the publication of the main trial findings. The dataset will be in Excel format and will be shared with other research teams for the purpose of contributing to systematic reviews, meta-analyses and other analyses focused on replicability of results. All participants gave their consent to participate in this study, signing a written consent form. All data will be anonymized, and data that may risk identification will be deleted before sharing.

Study outputs

Output type	Details	Date added	Peer reviewed?	Patient-facing?
Protocol file		04/05/2021	No	No
Participant information sheet		14/07/2022	No	Yes
Protocol file	version 2022	14/07/2022	No	No

Additional files

ISRCTN99438057_PROTOCOL.pdf: uploaded 04/05/2021
39661_PROTOCOL v2022.pdf
39661_PIS.pdf

Editorial Notes

21/07/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/07/2023 to 31/12/2023.
2. The overall end date was changed from 31/12/2023 to 31/12/2024.
3. The intention to publish date was changed from 01/12/2023 to 30/03/2025.
4. The plain English summary was updated to reflect these changes.
21/10/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2022 to 15/07/2023.
2. The overall end date was changed from 31/12/2022 to 31/12/2023.
3. The intention to publish date was changed from 01/03/2023 to 01/12/2023.
4. The plain English summary was updated to reflect these changes.
14/07/2022: The following changes were made to the trial record:
1. Uploaded protocol v2022 (not peer-reviewed) as an additional file.
2. The interventions were changed.
3. The primary outcome measure was changed.
4. The participant information sheet was uploaded as an additional file.
04/05/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date.
08/04/2021: Internal review.
24/03/2021: Trial's existence confirmed by the Ethics Committee on Human Research (CEIH), University of Granada.