Post Traumatic Stress DisorderNCT05218031
Acceptance and Commitment Group Therapy for Unaccompanied Minors
A study testing Acceptance and Commitment Therapy in people with Post Traumatic Stress Disorder and Depression, run by University of Cyprus.
Trial summary
Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression, Anxiety Disorders
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Unaccompanied refugee minors living in sheltered accommodation in Cyprus.
- No specific diagnosis required to take part in the study.
- No specific cultural background required.
- Minors who provide consent.
Who cannot join
- Presence of active psychosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acceptance and Commitment Group Therapy for Unaccompanied Minors: A Pilot Study
Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.
Read the detailed description
The hypotheses of the study are as follows:
- The ACT group intervention will lead to increases in UM psychological well-being and quality of life compared to a waiting-list (WL) control group. This includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (Primary outcomes).
- The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes).
- At post-intervention, UM receiving the ACT group intervention will have enhanced psychological flexibility compared to the WL control group. It is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (Secondary outcomes).
- At the 1-month and 3-month follow-up time points, the UM receiving the ACT group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the WL control group. Additionally, it is predicted that UM who completed the ACT group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the WL control group.
From the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Unaccompanied Refugee Minors, Acceptance and Commitment Therapy, Child/Adolescent Mental Health, Quality of Life
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
A 90-120 minute 5-week group intervention for unaccompanied minors. Each week there will be a different focus. Week 1: Grounding, Week 2: Unhooking, Week 3: Values, Week 4: Self-compassion, Week 5: Making room for unwanted thoughts and feelings.
| Study group | Role | What they receive |
|---|---|---|
| ACT Intervention | Experimental | 5-week ACT Group Intervention based on the Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Receives: Behavioral: Acceptance and Commitment Therapy |
| Control group | No intervention | Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).
This is a 27-item instrument that consists of five dimensions of quality of life: physical well-being (5 items), psychological well-being (7 items), autonomy and relationship with parents (7 items), peers and social support (4 items), and school environment (4 items). The questions concern the last seven days and answers are given on a five-point Likert scale ('Not at all, slightly, moderately, very, extremely' or 'never, seldom, quite often, very often, always'). Higher scores on the KIDSCREEN-27 reflect higher quality of life and wellbeing. Internal consistency of this scale was considered satisfactory (Cronbach's alpha= >.70).
Measured: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).
This scale includes 21 items and will be used to assess for symptoms of depression, anxiety and stress in our sample. The Depression scale assesses hopelessness, low self-esteem, and low positive affect. The Anxiety scale assesses autonomic arousal, physiological hyperarousal, and the subjective feeling of fear. The Stress scale items assess tension, agitation, and negative affect. There are seven items per scale and participants must rate their past week on a Likert-type scale (0-3). Higher scores indicate higher levels of depression, stress and anxiety. Cronbach's alphas indicating high internal consistency for Depression .94, Anxiety .84 and Stress .91.
Measured: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).
This scale will be used to assess for any post-traumatic stress symptoms. The total number of items in the scale are 8 items. Four of the items assess intrusion (intrusive thoughts, feelings) and the remaining four items assess avoidance (avoidance of situations, feelings). The items are scored on a 4- point scale, where higher scores indicate higher levels of intrusion or avoidance. The CRIES-13 (Smith, Perrin, Dyregov, \& Yule, 2003) was found to have high internal consistency (Cronbach's alpha= 0.80). Sensitivity (i.e., the probability that someone with a diagnosis of PTSD will screen positive) was found to be .94-1.0. Specificity (i.e., the probability that someone without a diagnosis of PTSD will screen negative) was found to be .59-.71. The overall efficiency rate of the CRIES-8 is 75-82.7%.
Measured: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).
This questionnaire consists of 25 items divided into five subscales with 5 items each: Emotional difficulties, Conduct problems, Hyperactivity/inattention, Peer problems and Prosocial behaviour. Each item is scored on a 3-point scale (0= 'not true', 1='somewhat true', and 2= 'certainly true'). Subscale scores are calculated by summing scores on relevant items (after recoding reversed items). Higher scores on the prosocial behaviour subscale indicate strengths, whilst higher scores on the other four subscales indicate difficulties. A total difficulties score is computed by summing the scores on all five subscales (range 0-40). Reliability of this scale is satisfactory as assessed by internal consistency (Cronbach's alpha=0.73), cross-informant correlation (mean= 0.34), and retest stability after 4 to 6 months (mean= 0.62).
Measured: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
Secondary outcomes (1)
Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).
This is an 8-item self-report questionnaire which assesses the process of psychological flexibility. Each item is rated on a five-point scale from 1 (very often) to 5 (very rarely).
Measured: Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm randomised trial will be conducted (brief ACT-based intervention vs. waiting-list control group)
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Karekla, University of Cyprus
- Investigators
- Maria Karekla, Ph.D., Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218031
- Sponsor's protocol ID
- K3_K1_1
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Group Therapy for Unaccompanied Minors: A Pilot Study
- ClinicalTrials.gov ID
- NCT05218031
- Acronym / sponsor ID
- K3_K1_1
- Keywords
- Unaccompanied Refugee Minors, Acceptance and Commitment Therapy, Child/Adolescent Mental Health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.
Detailed description
The hypotheses of the study are as follows:
- The ACT group intervention will lead to increases in UM psychological well-being and quality of life compared to a waiting-list (WL) control group. This includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (Primary outcomes).
- The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes).
- At post-intervention, UM receiving the ACT group intervention will have enhanced psychological flexibility compared to the WL control group. It is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (Secondary outcomes).
- At the 1-month and 3-month follow-up time points, the UM receiving the ACT group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the WL control group. Additionally, it is predicted that UM who completed the ACT group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the WL control group.
From the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm randomised trial will be conducted (brief ACT-based intervention vs. waiting-list control group)
| Arm | Type | Receives |
|---|---|---|
| ACT Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy5-week ACT Group Intervention based on the Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". |
| Control group | No intervention | –Waiting-list |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Unaccompanied refugee minors living in sheltered accommodation in Cyprus.
- No specific diagnosis required to take part in the study.
- No specific cultural background required.
- Minors who provide consent.
Key exclusion criteria (1 listed)
- Presence of active psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyA 90-120 minute 5-week group intervention for unaccompanied minors. Each week there will be a different focus. Week 1: Grounding, Week 2: Unhooking, Week 3: Values, Week 4: Self-compassion, Week 5: Making room for unwanted thoughts and feelings. | Behavioural | ACT Intervention |
Primary outcome
Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).
Time frame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
This is a 27-item instrument that consists of five dimensions of quality of life: physical well-being (5 items), psychological well-being (7 items), autonomy and relationship with parents (7 items), peers and social support (4 items), and school environment (4 items). The questions concern the last seven days and answers are given on a five-point Likert scale ('Not at all, slightly, moderately, very, extremely' or 'never, seldom, quite often, very often, always'). Higher scores on the KIDSCREEN-27 reflect higher quality of life and wellbeing. Internal consistency of this scale was considered satisfactory (Cronbach's alpha= >.70).
Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).
Time frame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
This scale includes 21 items and will be used to assess for symptoms of depression, anxiety and stress in our sample. The Depression scale assesses hopelessness, low self-esteem, and low positive affect. The Anxiety scale assesses autonomic arousal, physiological hyperarousal, and the subjective feeling of fear. The Stress scale items assess tension, agitation, and negative affect. There are seven items per scale and participants must rate their past week on a Likert-type scale (0-3). Higher scores indicate higher levels of depression, stress and anxiety. Cronbach's alphas indicating high internal consistency for Depression .94, Anxiety .84 and Stress .91.
Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).
Time frame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
This scale will be used to assess for any post-traumatic stress symptoms. The total number of items in the scale are 8 items. Four of the items assess intrusion (intrusive thoughts, feelings) and the remaining four items assess avoidance (avoidance of situations, feelings). The items are scored on a 4- point scale, where higher scores indicate higher levels of intrusion or avoidance. The CRIES-13 (Smith, Perrin, Dyregov, \& Yule, 2003) was found to have high internal consistency (Cronbach's alpha= 0.80). Sensitivity (i.e., the probability that someone with a diagnosis of PTSD will screen positive) was found to be .94-1.0. Specificity (i.e., the probability that someone without a diagnosis of PTSD will screen negative) was found to be .59-.71. The overall efficiency rate of the CRIES-8 is 75-82.7%.
Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).
Time frame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
This questionnaire consists of 25 items divided into five subscales with 5 items each: Emotional difficulties, Conduct problems, Hyperactivity/inattention, Peer problems and Prosocial behaviour. Each item is scored on a 3-point scale (0= 'not true', 1='somewhat true', and 2= 'certainly true'). Subscale scores are calculated by summing scores on relevant items (after recoding reversed items). Higher scores on the prosocial behaviour subscale indicate strengths, whilst higher scores on the other four subscales indicate difficulties. A total difficulties score is computed by summing the scores on all five subscales (range 0-40). Reliability of this scale is satisfactory as assessed by internal consistency (Cronbach's alpha=0.73), cross-informant correlation (mean= 0.34), and retest stability after 4 to 6 months (mean= 0.62).
1 secondary outcome
Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).
Time frame: Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Karekla, Ph.D. principal investigator
University of Cyprus
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Post Traumatic Stress Disorder and Depression, run by University of Cyprus.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Karekla, Ph.D. (0035722892100, mkarekla@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007). (time frame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up). The study lists 4 primary outcomes in all. 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 1 Feb 2022.