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Cognitive behavioural therapy for relatives of missing persons: study protocol for a pilot randomized controlled trial.


- candidate number19284
- NTR NumberNTR4732
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2014
- Secondary IDsM14.158652  METc UMCG
- Public TitleCognitive behavioural therapy for relatives of missing persons: study protocol for a pilot randomized controlled trial.
- Scientific TitleCognitive behavioural therapy for relatives of missing persons: study protocol for a pilot randomized controlled trial.
- ACRONYM
- hypothesisThe main aim of this project is to conduct a pilot randomized controlled trail (RCT) to evaluate the preliminary effectiveness and feasibility of cognitive behavioral therapy (CBT) as an intervention for relatives of long-term missing persons. The effectiveness of CBT will be compared to a wait-list control group. Relatives of missing persons with clinically elevated levels of depression, PTSD and/or complicated grief are eligible for the individual CBT that aims to learn the individuals to deal with the unresolved loss of a loved one.
It is hypothesized that participants of the intervention group will show lower levels of psychological complaints by reducing repetitive negative thinking and intrusive memories and enhancing self-compassion in comparison to the participants of the wait-list control group at post-treatment measurement. Follow-up measurements at three and six months post-treatment will show the short- and long-term effects of the intervention.
- Healt Condition(s) or Problem(s) studiedDistress, Cognitive behavior therapy, Missing persons
- Inclusion criteria- Relatives of persons whom are missing for at least three months. Relatives are defined as family members (including (adoption- or step family), partner and friends;
- Clinically elevated levels of:
depression (score of > 25 on the IDS-SR) and/or complicated grief (score of >90 on the ITG) and/or PTSD (A provisional PTSD diagnosis can be made by treating each item on the PTSD Checklist for the DSM5 (PCL-5) rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20)).

A clinical interview conducted by a trained professional has to confirm a diagnosis of depression, PTSD and/or complicated grief.

- > 18 years of age;
- written informed consent;
- mastering the Dutch language.
- Exclusion criteria- Relatives with high suicidal risk;
- or substance use disorder (based on questionnaire and/or interview).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-apr-2017
- Target number of participants60
- InterventionsParticipants are randomized into:
1. Experimental condition
2. Wait-list control condition (with full access to usual care) Experimental condition Participants in the experimental condition are referred to a trained psychologist in their region. Approximately 15 psychologists are trained to conduct the CBT according to the treatment-protocol. The CBT consists of eight sessions divided over 12 weeks. The rationale for the treatment is based on previous studies that showed the effectiveness of CBT for reducing depression, PTSD and complicated grief. Due to the ongoing uncertainty and lack of closure for the relatives of missing persons, the therapy is not only focused on reducing psychological complaints, but also focused on enhancing coping strategies to deal with the painful situation by integrating mindfulness exercises. The treatment protocol is as follows: Session 1 - identification of psychological complaints, diagnosis, psycho-education. Session 2- invite a friend of family member, social support Session 3 - introduction of mindfulness Session 4 - 7 Recognition and changing maladaptive thoughts. Session 8 - evaluation of the therapy and relapse prevention During the therapy the participant is recommended to read chapters from the workbook (psycho-education) and to do home exercises (e.g. mindfulness exercises and recognition of changing maladaptive thoughts exercises). The exercises are based on previous literature from CBT and mindfulness. Before each session (except for session 1) the participant is asked to answer a maximum of 10 questions about changing mechanisms, in order to evaluate the progress during the therapy. Wait-list control condition Participants who are randomized to the wait-list control condition have full access to usual care. After a waiting period of 12 weeks they start with the intervention. The intervention is the same as the intervention for the experimental condition.
- Primary outcomeDifferences in mean score of depression (assessed by the IDS-SR), PTSD (assessed by the PCL-5) and complicated grief (assessed by the ITG) at pre-, post and follow-up measurements after 12 and 24 weeks.
- Secondary outcomeDifferences in mean scores of repetitive negative thinking, rumination, intrusions, coping with unresolved loss, self-compassion, quality of life and satisfaction with life
- TimepointsPretreatment, posttreatment, follow-up measure after 12 weeks and follow-up measure after 24 weeks.
- Trial web sitewww.levenmetvermissing.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.I.M. Lenferink
- CONTACT for SCIENTIFIC QUERIES L.I.M. Lenferink
- Sponsor/Initiator University of Groningen
- Funding
(Source(s) of Monetary or Material Support)
University of Groningen, Fonds Slachtofferhulp Nederland (Victim Support Fund, the Netherlands), Promotion fund Bereavement Foundation (Stichting Stimuleringsfonds Rouw)
- Publications
- Brief summaryThe preliminary effectiveness and feasibility of cognitive behavioral therapy (CBT) as an intervention for relatives of long-term missing persons will be evaluated in a pilot randomized controlled trial. An intervention group will be compared to a wait-list control group. It is hypothesized that participants of the intervention group will show lower levels of psychological complaints by reducing repetitive negative thinking and intrusive memories and enhancing self-compassion in comparison to the participants of the wait-list control group at post-treatment measurement. Follow-up measurements at three and six months post-treatment will show the short- and long-term effects of the intervention.
- Main changes (audit trail)1.inclusie criteria:

OLD
- Clinically elevated levels of:
depression (score of > 25 on the IDS-SR) and/or complicated grief (score of >90 on the ITG) and/or PTSD (A provisional PTSD diagnosis can be made by treating each item on the PTSD Checklist for the DSM5 (PCL-5) rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20)).

NEW
Clinically elevated levels of:
depression (score of > 13 on the IDS-SR) and/or complicated grief (score of >25 on the ITG) and/or PTSD (A provisional PTSD diagnosis can be made by treating each item on the PTSD Checklist for the DSM5 (PCL-5) rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20)), or a totalscore score of > 38

2. Interventions

OLD
Participants are randomized into:
1. Experimental condition
2. Wait-list control condition (with full access to usual care) Experimental condition Participants in the experimental condition are referred to a trained psychologist in their region. Approximately 15 psychologists are trained to conduct the CBT according to the treatment-protocol. The CBT consists of eight sessions divided over 12 weeks. The rationale for the treatment is based on previous studies that showed the effectiveness of CBT for reducing depression, PTSD and complicated grief. Due to the ongoing uncertainty and lack of closure for the relatives of missing persons, the therapy is not only focused on reducing psychological complaints, but also focused on enhancing coping strategies to deal with the painful situation by integrating mindfulness exercises. The treatment protocol is as follows: Session 1 - identification of psychological complaints, diagnosis, psycho-education. Session 2- invite a friend of family member, social support Session 3 - introduction of mindfulness Session 4 - 7 Recognition and changing maladaptive thoughts. Session 8 - evaluation of the therapy and relapse prevention During the therapy the participant is recommended to read chapters from the workbook (psycho-education) and to do home exercises (e.g. mindfulness exercises and recognition of changing maladaptive thoughts exercises). The exercises are based on previous literature from CBT and mindfulness. Before each session (except for session 1) the participant is asked to answer a maximum of 10 questions about changing mechanisms, in order to evaluate the progress during the therapy. Wait-list control condition Participants who are randomized to the wait-list control condition have full access to usual care. After a waiting period of 12 weeks they start with the intervention. The intervention is the same as the intervention for the experimental condition.

NEW
Participants are randomized into:
1. Experimental condition
2. Wait-list control condition.


Experimental condition
Participants in the experimental condition are referred to a trained psychologist in their region. Approximately 15 psychologists are trained to conduct the CBT according to the treatment-protocol. The CBT consists of eight sessions divided over 12 weeks. The rationale for the treatment is based on previous studies that showed the effectiveness of CBT for reducing depression, PTSD and complicated grief. Due to the ongoing uncertainty and lack of closure for the relatives of missing persons, the therapy is not only focused on reducing psychological complaints, but also focused on enhancing coping strategies to deal with the painful situation by integrating mindfulness exercises. The treatment protocol is as follows: Session 1 - identification of psychological complaints, diagnosis, psycho-education. Session 2- invite a friend of family member, social support Session 3 - introduction of mindfulness Session 4 - 7 Recognition and changing maladaptive thoughts. Session 8 - evaluation of the therapy and relapse prevention During the therapy the participant is recommended to read chapters from the workbook (psycho-education) and to do home exercises (e.g. mindfulness exercises and recognition of changing maladaptive thoughts exercises). The exercises are based on previous literature from CBT and mindfulness. Before each session the participant is asked to answer a short questionnaire, in order to evaluate the progress during the therapy.

Wait-list control condition
Participants who are randomized to the wait-list control will start the intervention after 12 weeks. The intervention is the same as the intervention for the experimental condition.

3. Secondary outcomes

OLD
Differences in mean scores of repetitive negative thinking, rumination, intrusions, coping with unresolved loss, self-compassion, quality of life and satisfaction with life

NEW
Differences in mean scores of repetitive negative thinking, rumination, intrusions, coping with unresolved loss and self-compassion
- RECORD12-aug-2014 - 13-okt-2015


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