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    Clinical Trial Results:
    TREATMENT OF SLEEP DISTURBANCES IN TRAUMA-AFFECTED REFUGEES – A RANDOMISED CONTROLLED TRIAL

    Summary
    EudraCT number
    		 2015-004153-40
    Trial protocol
    		 DK  
    Global end of trial date
    18 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2021
    First version publication date
    01 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PTF5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Ethics committe: H-15014503
    Sponsors
    Sponsor organisation name
    Competence centre for Transcultural Psychiatry
    Sponsor organisation address
    Maglevaenget 21, Ballerup, Denmark, 2750
    Public contact
    Hinuga Sandahl, Competence Centre for Transcultural Psychiatry, 45 26847112, hinuga.sandahl.01@regionh.dk
    Scientific contact
    Hinuga Sandahl, Competence Centre for Transcultural Psychiatry, 45 26847112, hinuga.sandahl.01@regionh.dk
    Sponsor organisation name
    Competence Centre for Transcultural Psychiatry
    Sponsor organisation address
    Maglevaenget 21, Ballerup, Denmark, 2750
    Public contact
    Jessica Carlsson, Competence Centre for Transcultural Psychiatry, 45 38646180, jessica.carlsson.lohmann@regionh.dk
    Scientific contact
    Jessica Carlsson, Competence Centre for Transcultural Psychiatry, 45 38646180, jessica.carlsson.lohmann@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomised controlled trial. The objectives are: 1. To estimate treatment effects of IRT and mianserin on sleep quality, sleep length and nightmares compared to treatment as usual (TAU) at CTP (Se description below) 2. To study the relation between enhanced sleep, PTSD-symptoms, observer rated functioning and self-rated quality of life 3. To examine predictors for positive outcome of treatment
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 219
    Worldwide total number of subjects
    219
    EEA total number of subjects
    219
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    217
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In the period from March 2016 to April 2018, 1125 patients consecutively referred to treatment at Competence Centre for Transcultural Psychiatry were screened for the study and 240 patients were randomized.

    Pre-assignment
    Screening details
    		 A total of 21 participants, equally distributed in the intervention groups, were excluded from analysis due to withdrawal of informed consent, error in error in eligibility assessment, or due to emergence of pregnancy or psychosis during the study. The modified intention-to-treat sample hence consisted of 219 participants.

    Period 1
    Period 1 title
    overall period (pre-post treatment)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Blinded assessors performed the HAM-D and HAM-A ratings pre- and post-treatment. Asessors were blinded for intervention group and pre/post and 6-months follow-up time.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment as usual (TAU)
    Arm description
    		 TAU was an interdisciplinary treatment approach, covering a period of 8-12 months, with medicine according to standard at CTP (best clinical practice in the field), physiotherapy, psychoeducation (including sleep hygiene education and relaxation techniques), and manual-based CBT. The treatment was two-phased, phase one: 2-4 months treatment provided by physician and physiotherapist, phase two: 4-8 months of combined treatment provided by both physician and psychologist. For a detailed description of TAU, please see study protocol (Sandahl, Jennum, et al., 2017). Experienced interpreters were present in sessions, if needed, and during conduction of ratings, as required. 5 patients withdrawn, please see publiction for reason
    Arm type
    		 Treatment as usual

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Mianserin
    Arm description
    		 Mianserin was prescribed and delivered to the participant by the treating physician and initiated at 10 mg before bedtime. The dose could be increased gradually to a maximum dosage of 30 mg adjusted according to effect and side effects. At each session with the physician, the participants were asked to report whether they had taken their medication as prescribed, and the current dose of mianserin was registered. Adherence was monitored by measuring the plasma concentration of mianserin after phase one and phase two (post-treatment). 6 patients withdrawn, please see publiction for reason
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mianserin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10-30 mg

    Arm title
    		 Imagery Rehearsal Therapy
    Arm description
    		 IRT was integrated in six sessions of manual-based CBT in sessions administered by a psychologist. The sessions IRT treatment consisted of three components 1) psychoeducation on disturbing dreams, nightmares and sleep as well as exercises in cognitive restructuring and 2) imaginationimagery education and positive imagery exercises, enabling the patient to transform the 3) imagery rescripting of the disturbing dream or nightmare and rehearsal of into a new and non-disturbing dream. The manual was developed to accommodate for individual differences in the participants and allowed the therapist flexibility in sequencing of components. However, positive imagery exercises had to be performed prior to initiating imagery rescripting. The number of sessions devoted to each component was flexible and accustomed to the individual participant. All psychologists were trained and supervised in this specific method, described in detail in the IRT manual available at ctp-net.dk.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IRT (therapy)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear ointment
    Routes of administration
    Other use
    Dosage and administration details
    Pharmaceutical form not relevant for therapy

    Arm title
    		 IRT + mianserin
    Arm description
    		 4 patients withdrawn, please see publiction for reason
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mianserin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10-30 mg

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Blinded assessors performed the HAM-D and HAM-A ratings pre- and post-treatment. Asessors were blinded for intervention group and pre/post and 6-months follow-up time.
    Number of subjects in period 1
    		Treatment as usual (TAU) Mianserin Imagery Rehearsal Therapy IRT + mianserin
    Started
    55
    54
    56
    54
    Completed
    55
    54
    56
    54

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall period (pre-post treatment)
    Reporting group description
    		 -

    Reporting group values
    		 overall period (pre-post treatment) Total
    Number of subjects
    		 219 219
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    		 109 109
        Male
    		 110 110

    End points

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    End points reporting groups
    Reporting group title
    Treatment as usual (TAU)
    Reporting group description
    		 TAU was an interdisciplinary treatment approach, covering a period of 8-12 months, with medicine according to standard at CTP (best clinical practice in the field), physiotherapy, psychoeducation (including sleep hygiene education and relaxation techniques), and manual-based CBT. The treatment was two-phased, phase one: 2-4 months treatment provided by physician and physiotherapist, phase two: 4-8 months of combined treatment provided by both physician and psychologist. For a detailed description of TAU, please see study protocol (Sandahl, Jennum, et al., 2017). Experienced interpreters were present in sessions, if needed, and during conduction of ratings, as required. 5 patients withdrawn, please see publiction for reason

    Reporting group title
    Mianserin
    Reporting group description
    		 Mianserin was prescribed and delivered to the participant by the treating physician and initiated at 10 mg before bedtime. The dose could be increased gradually to a maximum dosage of 30 mg adjusted according to effect and side effects. At each session with the physician, the participants were asked to report whether they had taken their medication as prescribed, and the current dose of mianserin was registered. Adherence was monitored by measuring the plasma concentration of mianserin after phase one and phase two (post-treatment). 6 patients withdrawn, please see publiction for reason

    Reporting group title
    Imagery Rehearsal Therapy
    Reporting group description
    		 IRT was integrated in six sessions of manual-based CBT in sessions administered by a psychologist. The sessions IRT treatment consisted of three components 1) psychoeducation on disturbing dreams, nightmares and sleep as well as exercises in cognitive restructuring and 2) imaginationimagery education and positive imagery exercises, enabling the patient to transform the 3) imagery rescripting of the disturbing dream or nightmare and rehearsal of into a new and non-disturbing dream. The manual was developed to accommodate for individual differences in the participants and allowed the therapist flexibility in sequencing of components. However, positive imagery exercises had to be performed prior to initiating imagery rescripting. The number of sessions devoted to each component was flexible and accustomed to the individual participant. All psychologists were trained and supervised in this specific method, described in detail in the IRT manual available at ctp-net.dk.

    Reporting group title
    IRT + mianserin
    Reporting group description
    		 4 patients withdrawn, please see publiction for reason

    Primary: Pittsburgh Sleep Quality Index

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    End point title
    		 Pittsburgh Sleep Quality Index [1]
    End point description
    End point type
    Primary
    End point timeframe
    Timepoint pre-treatment, after 2-3 months of treatment, post-treatment and follow-up.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see attached table and publication for statistical analysis.
    End point values
    		 Treatment as usual (TAU) Mianserin Imagery Rehearsal Therapy IRT + mianserin
    Number of subjects analysed
    55
    54
    56
    54
    Units: Scale points
        arithmetic mean (standard error)
    15.60 ± 0.41
    16.42 ± 0.38
    16.58 ± 0.39
    16.42 ± 0.42
    Attachments
    		 Untitled (Filename: Table S2 Mixed model analyses intention-to-treat sample four intervention groups.docx)
    No statistical analyses for this end point

    Secondary: Harvard Trauma Questionnaire

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    End point title
    		 Harvard Trauma Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    pre-treatment, after 2-3 months of treatment, post-treatment and follow-up.
    End point values
    		 Treatment as usual (TAU) Mianserin Imagery Rehearsal Therapy IRT + mianserin
    Number of subjects analysed
    55
    54
    56
    54
    Units: scale points
        arithmetic mean (standard error)
    2.84 ± 0.10
    3.15 ± 0.07
    2.86 ± 0.10
    2.89 ± 0.10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event were reported post-treatment.
    Adverse event reporting additional description
    The participants were asked about adverse events in each session with a physician and events were registered in accordance with definitions and current legislation by the Danish Medicines Agency (Medicines Agency, n.d.). In addition, all discomfort in connection with psychotherapy was registered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No Dictionary
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Treatment as usual (TAU)
    Reporting group description
    		 TAU was an interdisciplinary treatment approach, covering a period of 8-12 months, with medicine according to standard at CTP (best clinical practice in the field), physiotherapy, psychoeducation (including sleep hygiene education and relaxation techniques), and manual-based CBT. The treatment was two-phased, phase one: 2-4 months treatment provided by physician and physiotherapist, phase two: 4-8 months of combined treatment provided by both physician and psychologist. For a detailed description of TAU, please see study protocol (Sandahl, Jennum, et al., 2017). Experienced interpreters were present in sessions, if needed, and during conduction of ratings, as required.

    Reporting group title
    Mianserin
    Reporting group description
    		 Mianserin was prescribed and delivered to the participant by the treating physician and initiated at 10 mg before bedtime. The dose could be increased gradually to a maximum dosage of 30 mg adjusted according to effect and side effects. At each session with the physician, the participants were asked to report whether they had taken their medication as prescribed, and the current dose of mianserin was registered. Adherence was monitored by measuring the plasma concentration of mianserin after phase one and phase two (post-treatment).

    Reporting group title
    Imagery Rehearsal Therapy
    Reporting group description
    		 IRT was integrated in six sessions of manual-based CBT in sessions administered by a psychologist. The sessions IRT treatment consisted of three components 1) psychoeducation on disturbing dreams, nightmares and sleep as well as exercises in cognitive restructuring and 2) imaginationimagery education and positive imagery exercises, enabling the patient to transform the 3) imagery rescripting of the disturbing dream or nightmare and rehearsal of into a new and non-disturbing dream. The manual was developed to accommodate for individual differences in the participants and allowed the therapist flexibility in sequencing of components. However, positive imagery exercises had to be performed prior to initiating imagery rescripting. The number of sessions devoted to each component was flexible and accustomed to the individual participant. All psychologists were trained and supervised in this specific method, described in detail in the IRT manual available at ctp-net.dk.

    Reporting group title
    IRT + mianserin
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment as usual (TAU) Mianserin Imagery Rehearsal Therapy IRT + mianserin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Suicidal ideation
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment as usual (TAU) Mianserin Imagery Rehearsal Therapy IRT + mianserin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 55 (5.45%)
    32 / 54 (59.26%)
    2 / 56 (3.57%)
    30 / 54 (55.56%)
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    2 / 55 (3.64%)
    20 / 54 (37.04%)
    1 / 56 (1.79%)
    14 / 54 (25.93%)
         occurrences all number
    2
    20
    1
    14
    Dizziness
         subjects affected / exposed
    0 / 55 (0.00%)
    6 / 54 (11.11%)
    0 / 56 (0.00%)
    7 / 54 (12.96%)
         occurrences all number
    0
    6
    0
    7
    Somnolence
         subjects affected / exposed
    0 / 55 (0.00%)
    11 / 54 (20.37%)
    0 / 56 (0.00%)
    5 / 54 (9.26%)
         occurrences all number
    0
    11
    0
    5
    Headache
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 54 (5.56%)
    0 / 56 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    0
    3
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
    Additional description: Desciption of heavy body
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 54 (3.70%)
    0 / 56 (0.00%)
    6 / 54 (11.11%)
         occurrences all number
    0
    2
    0
    6
    Metabolism and nutrition disorders
    Weight increased
         subjects affected / exposed
    0 / 55 (0.00%)
    4 / 54 (7.41%)
    0 / 56 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    4
    0
    2
    Dry mouth
         subjects affected / exposed
    0 / 55 (0.00%)
    4 / 54 (7.41%)
    1 / 56 (1.79%)
    7 / 54 (12.96%)
         occurrences all number
    0
    4
    1
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33529449
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