<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02970279</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol Version 3.0</org_study_id>
    <nct_id>NCT02970279</nct_id>
  </id_info>
  <brief_title>Reducing Stasis Outcomes for Depression in Group Behavioural Activation Therapy</brief_title>
  <official_title>Effect of Treatment Augmentations Embedded in Behavioural Activation Group Therapy on Reducing Drop-out and Stasis Rates in Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheffield Health and Social Care NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Howard Morton Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sheffield</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression is one of the most common mental health disorders and it is estimated up to 50% of&#xD;
      patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis'&#xD;
      outcome. However, there is limited research understanding this population, meaning a&#xD;
      considerable number of people continue to suffer. The purpose of this study is to 1) identify&#xD;
      depression stasis prevalence and predictors in an existing evidenced-based group treatment&#xD;
      for depression, 2) run a clinical trial to test whether an embedded intervention based on&#xD;
      theoretical and clinical practice evidence can help reduce patient depression stasis and&#xD;
      drop-out rates and 3) understand what aspect of therapy produces change (or prevents change&#xD;
      in stasis). The study will be based on behavioural activation (BA) therapy delivered in an&#xD;
      eight-session group format in an Improving Access to Psychological Therapies (IAPT) service&#xD;
      in the United Kingdom. BA is one of the most effective psychotherapies available for&#xD;
      depression and focuses on helping patients to increase their engagement with valued&#xD;
      activities to help break out of the cycle of depression. Firstly, an archived anonymised&#xD;
      dataset of routine depression measures from patients who have previously received the&#xD;
      existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to&#xD;
      patients in 2017 will be enhanced with two treatment augmentations. One augmentation will&#xD;
      target stasis outcomes through the addition of specific 'if-then' planning (known as&#xD;
      implementation intentions) when setting between-session homework and the other augmentation&#xD;
      will target patient drop-out by informing patients about group BA effectiveness and&#xD;
      therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in&#xD;
      the trial will be compared with the archived outcomes to see if the intervention has had an&#xD;
      effect and the role of engaging in valued living as a mechanism of change for depression&#xD;
      symptoms will be examined. It is hypothesised that a) 50% of patients who have received the&#xD;
      existing BA group treatment for depression will have a stasis outcome, b) there will be a&#xD;
      significant reduction in depression stasis outcomes and drop-out rate following the enhanced&#xD;
      BA group treatment delivered in the trial and c) engagement in valued living will have a&#xD;
      mediating effect on outcome for responding patients following the enhanced BA group treatment&#xD;
      but the effect will not be present for patients with a stasis outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A one-armed quasi-experimental trial will be used to test the effect of two embedded&#xD;
      behavioural activation group (BAG) treatment augmentations on treatment outcomes and to&#xD;
      identify a potential outcome mediator for patients with a stasis outcome. A non-randomised&#xD;
      design enables data to be collected which reflects routine clinical practice and address&#xD;
      stasis outcomes as they occur in real-world services. A matched pairs design will be&#xD;
      implemented in the analysis to allow comparison of the enhanced BAG data with historical&#xD;
      control data from archived outcomes of the existing treatment (i.e. the baseline data).&#xD;
&#xD;
      Patients who access the Improving Access to Psychological Therapies (IAPT) service in&#xD;
      Sheffield, United Kingdom with a primary presenting problem of depression and are referred to&#xD;
      BAG will be approached to take part in the study. Patients will be asked to provide informed&#xD;
      consent to agree for their weekly routine outcome scores from enhanced BAG to be used in the&#xD;
      study.&#xD;
&#xD;
      Enhanced BAG Augmentations&#xD;
&#xD;
      The existing BAG treatment will be enhanced with embedded treatment augmentations. The&#xD;
      augmentations will consist of two strands; 1) implementation intentions to directly target&#xD;
      reducing stasis and 2) psychoeducation to target reducing drop-out.&#xD;
&#xD;
      Implementation Intentions: The first augmentation will be a top-down theoretically informed&#xD;
      'implementation intentions' enhancement to target reducing the stasis outcome rate.&#xD;
      Implementation intentions are specific plans about how, when and where goals will be acted&#xD;
      upon, formed using an if-then format in order to effectively implement actions. Patients will&#xD;
      be taught to use if-then planning (implementation intentions) to help them complete the&#xD;
      between-session which is crucial to producing change in BA.&#xD;
&#xD;
      Dose-Response Psychoeducation: The second augmentation will be a dose-response&#xD;
      psychoeducation enhancement aimed at reducing the dropout rate. Patients will be given&#xD;
      information based on practice-based evidence about the effectiveness of BAG and dose-response&#xD;
      information (minimum number of sessions required to experience change).&#xD;
&#xD;
      Treatment Integrity&#xD;
&#xD;
      Treatment adherence to the protocol will be assessed using a BAG adherence checklist created&#xD;
      for this trial. Adherence will be checked and compared using self-report and an expert rater;&#xD;
      i) after each session the BAG facilitators will complete the session integrity measure to&#xD;
      check self-report adherence and ii) the BAG facilitator lead will observe and rate one&#xD;
      session from each course of BAG to provide an expert adherence check.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
      Data collection for the study will run for a year from January 2017 until December 2017&#xD;
      incorporating six BAG treatment groups.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      The data will be analysed using the intention-to-treat (ITT) principle. The final available&#xD;
      measure will be used as the post score or if there is only one score available, it will be&#xD;
      assumed there was no change. Patients who do not score above the clinical cut-off for&#xD;
      depression (score of ≥10 on Patient Health Questionnaire [PHQ-9]) prior to commencing BAG&#xD;
      will not be included in the analysis to avoid a floor effect when calculating stasis&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Health Questionnaire (PHQ-9) scores</measure>
    <time_frame>Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)</time_frame>
    <description>Validated 9-item self-report measure of depressive symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient attendance at treatment sessions</measure>
    <time_frame>Weeks 1-8 (every weekly treatment session - maximum of 8)</time_frame>
    <description>Number of therapy sessions patients attend in a course of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Valued Living Questionnaire (VLQ) score</measure>
    <time_frame>Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment)</time_frame>
    <description>Validated self-report measure of engagement in valued living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Generalised Anxiety Disorder Assessment (GAD-7) score</measure>
    <time_frame>Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)</time_frame>
    <description>Validated 7-item self-report measure of anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Work and Social Adjustment Scale (WSAS) score</measure>
    <time_frame>Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)</time_frame>
    <description>Validated self-report measure of functional impairment as a result of mental health problems</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Behavioural activation group (BAG) therapy adherence</measure>
    <time_frame>Weeks 1-8 (Every treatment session)</time_frame>
    <description>BAG facilitators will complete an therapy adherence checklist (designed for this trial) after each session. An external rater will rate one session of each course of treatment to ensure adherence to the treatment protocol</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Enhanced Behavioural Activation Groups</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations;&#xD;
Implementation intentions&#xD;
Dose-response psychoeducation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioural Activation Group (BAG) Psychotherapy</intervention_name>
    <description>Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.</description>
    <arm_group_label>Enhanced Behavioural Activation Groups</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who access the Sheffield Improving Access to Psychological Therapies (IAPT)&#xD;
             service (United Kingdom) with depression as the primary presenting problem&#xD;
&#xD;
          -  Patients with co-morbid anxiety symptoms can be included as long as depression is the&#xD;
             primary diagnosis&#xD;
&#xD;
          -  Are referred to and choose the Behavioural Activation Group (BAG) treatment option&#xD;
&#xD;
          -  Able to attend the BAG intervention&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis that is not depression&#xD;
&#xD;
          -  Patients who do not choose BAG as a treatment option&#xD;
&#xD;
          -  Aged under 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie K Simmonds-Buckley, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Kellett, DClinPsy</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield &amp; Sheffield Health and Social Care NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Glenn Waller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheffield Health and Social Care NHS Foundation Trust - Improving Access to Psychological Therapies Service</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S3 7ND</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Gollwitzer, P. M. (1999). Implementation intentions: Strong effects of simple plans. American Psychologist, 54, 493-503.</citation>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sheffield</investigator_affiliation>
    <investigator_full_name>Melanie Simmonds-Buckley</investigator_full_name>
    <investigator_title>PhD Research Student</investigator_title>
  </responsible_party>
  <keyword>Behavioural activation</keyword>
  <keyword>Psychotherapy, group</keyword>
  <keyword>Depression</keyword>
  <keyword>Depressive disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will be anonymised and analysed collectively so individual participant data will not be identifiable within any reports or publications.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02970279
org study id: Protocol Version 3.0
nct id: NCT02970279
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Depression is one of the most common mental health disorders and it is estimated up to 50% of
      patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis'
      outcome. However, there is limited research understanding this population, meaning a
      considerable number of people continue to suffer. The purpose of this study is to 1) identify
      depression stasis prevalence and predictors in an existing evidenced-based group treatment
      for depression, 2) run a clinical trial to test whether an embedded intervention based on
      theoretical and clinical practice evidence can help reduce patient depression stasis and
      drop-out rates and 3) understand what aspect of therapy produces change (or prevents change
      in stasis). The study will be based on behavioural activation (BA) therapy delivered in an
      eight-session group format in an Improving Access to Psychological Therapies (IAPT) service
      in the United Kingdom. BA is one of the most effective psychotherapies available for
      depression and focuses on helping patients to increase their engagement with valued
      activities to help break out of the cycle of depression. Firstly, an archived anonymised
      dataset of routine depression measures from patients who have previously received the
      existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to
      patients in 2017 will be enhanced with two treatment augmentations. One augmentation will
      target stasis outcomes through the addition of specific 'if-then' planning (known as
      implementation intentions) when setting between-session homework and the other augmentation
      will target patient drop-out by informing patients about group BA effectiveness and
      therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in
      the trial will be compared with the archived outcomes to see if the intervention has had an
      effect and the role of engaging in valued living as a mechanism of change for depression
      symptoms will be examined. It is hypothesised that a) 50% of patients who have received the
      existing BA group treatment for depression will have a stasis outcome, b) there will be a
      significant reduction in depression stasis outcomes and drop-out rate following the enhanced
      BA group treatment delivered in the trial and c) engagement in valued living will have a
      mediating effect on outcome for responding patients following the enhanced BA group treatment
      but the effect will not be present for patients with a stasis outcome.
A one-armed quasi-experimental trial will be used to test the effect of two embedded
      behavioural activation group (BAG) treatment augmentations on treatment outcomes and to
      identify a potential outcome mediator for patients with a stasis outcome. A non-randomised
      design enables data to be collected which reflects routine clinical practice and address
      stasis outcomes as they occur in real-world services. A matched pairs design will be
      implemented in the analysis to allow comparison of the enhanced BAG data with historical
      control data from archived outcomes of the existing treatment (i.e. the baseline data).

      Patients who access the Improving Access to Psychological Therapies (IAPT) service in
      Sheffield, United Kingdom with a primary presenting problem of depression and are referred to
      BAG will be approached to take part in the study. Patients will be asked to provide informed
      consent to agree for their weekly routine outcome scores from enhanced BAG to be used in the
      study.

      Enhanced BAG Augmentations

      The existing BAG treatment will be enhanced with embedded treatment augmentations. The
      augmentations will consist of two strands; 1) implementation intentions to directly target
      reducing stasis and 2) psychoeducation to target reducing drop-out.

      Implementation Intentions: The first augmentation will be a top-down theoretically informed
      'implementation intentions' enhancement to target reducing the stasis outcome rate.
      Implementation intentions are specific plans about how, when and where goals will be acted
      upon, formed using an if-then format in order to effectively implement actions. Patients will
      be taught to use if-then planning (implementation intentions) to help them complete the
      between-session which is crucial to producing change in BA.

      Dose-Response Psychoeducation: The second augmentation will be a dose-response
      psychoeducation enhancement aimed at reducing the dropout rate. Patients will be given
      information based on practice-based evidence about the effectiveness of BAG and dose-response
      information (minimum number of sessions required to experience change).

      Treatment Integrity

      Treatment adherence to the protocol will be assessed using a BAG adherence checklist created
      for this trial. Adherence will be checked and compared using self-report and an expert rater;
      i) after each session the BAG facilitators will complete the session integrity measure to
      check self-report adherence and ii) the BAG facilitator lead will observe and rate one
      session from each course of BAG to provide an expert adherence check.

      Data Collection

      Data collection for the study will run for a year from January 2017 until December 2017
      incorporating six BAG treatment groups.

      Data Analysis

      The data will be analysed using the intention-to-treat (ITT) principle. The final available
      measure will be used as the post score or if there is only one score available, it will be
      assumed there was no change. Patients who do not score above the clinical cut-off for
      depression (score of ≥10 on Patient Health Questionnaire [PHQ-9]) prior to commencing BAG
      will not be included in the analysis to avoid a floor effect when calculating stasis
      outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Patient Health Questionnaire (PHQ-9) scores
time frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
description: Validated 9-item self-report measure of depressive symptoms
measure: Patient attendance at treatment sessions
time frame: Weeks 1-8 (every weekly treatment session - maximum of 8)
description: Number of therapy sessions patients attend in a course of treatment
measure: Change in Valued Living Questionnaire (VLQ) score
time frame: Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment)
description: Validated self-report measure of engagement in valued living
measure: Change in Generalised Anxiety Disorder Assessment (GAD-7) score
time frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
description: Validated 7-item self-report measure of anxiety symptoms
measure: Change in Work and Social Adjustment Scale (WSAS) score
time frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
description: Validated self-report measure of functional impairment as a result of mental health problems
measure: Behavioural activation group (BAG) therapy adherence
time frame: Weeks 1-8 (Every treatment session)
description: BAG facilitators will complete an therapy adherence checklist (designed for this trial) after each session. An external rater will rate one session of each course of treatment to ensure adherence to the treatment protocol
arm group label: Enhanced Behavioural Activation Groups
arm group type: Experimental
description: Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations;
Implementation intentions
Dose-response psychoeducation
intervention type: Behavioral
intervention name: Behavioural Activation Group (BAG) Psychotherapy
description: Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.
arm group label: Enhanced Behavioural Activation Groups
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melanie K Simmonds-Buckley, BSc
role: Principal Investigator
affiliation: University of Sheffield
last name: Stephen Kellett, DClinPsy
role: Principal Investigator
affiliation: University of Sheffield & Sheffield Health and Social Care NHS Foundation Trust
last name: Glenn Waller, PhD
role: Principal Investigator
affiliation: University of Sheffield
facility: 
country: United Kingdom
citation: Gollwitzer, P. M. (1999). Implementation intentions: Strong effects of simple plans. American Psychologist, 54, 493-503.
responsible party type: Principal Investigator
investigator affiliation: University of Sheffield
investigator full name: Melanie Simmonds-Buckley
investigator title: PhD Research Student
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
ipd description: The data will be anonymised and analysed collectively so individual participant data will not be identifiable within any reports or publications.