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Behavioural Activation for Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Recruiting
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Behavioural Activation (BA)
Sponsored by
Reykjavik University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar depression, Bipolar Disorder, Behavioural Activation, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Mini International Neuropsychiatric Interview (MINI) 7.0.2 meeting diagnostic criteria for Bipolar I or II Disorder (MINI) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator. Exclusion Criteria: current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali. currently lacking the capacity to give informed consent currently receiving other psychosocial therapy for depression or bipolar disorder presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)

Sites / Locations

  • Landspitali university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

2 week wait

3 week wait

4 week wait

5 week wait

Arm Description

Participant waits for 2 weeks after their baseline assessment before commencing therapy.

Participant waits for 3 weeks after their baseline assessment before commencing therapy.

Participant waits for 4 weeks after their baseline assessment before commencing therapy.

Participant waits for 5 weeks after their baseline assessment before commencing therapy.

Outcomes

Primary Outcome Measures

Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Change in activity levels as measured by consumer connected health devices
Measures of activity levels as by Withings health devices
Change in Sleep Duration measured by health device
Measures of sleep duration by Withings health devices
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists

Secondary Outcome Measures

Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Mini International Neuropsychiatric Interview (MINI) 7.0.2
Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence
Young mania rating scale
11 item observer-rated scale measuring the severity of manic states
Six daily questions
Six daily questions in mobile about goal achievement, mood, sleep etc
The Quality of Behavioral Activation Scale (Q-BAS)
To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions

Full Information

First Posted
August 28, 2023
Last Updated
September 21, 2023
Sponsor
Reykjavik University
Collaborators
Landspitali University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06022913
Brief Title
Behavioural Activation for Bipolar Depression
Official Title
Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reykjavik University
Collaborators
Landspitali University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. Psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with BD. Behavioral activation therapy (BA) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. It helps people re-establish healthier activity patterns and sleep regulation, especially in BD for mood stabilization. BA is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering BA to people with BD. The first aim of the current research is to implement BA for people with depression in Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do a pilot study on the effectiveness of the treatment for this patient group. The research will be implemented with people seeking treatment at the specialized service for bipolar disorder at Landspítali University Hospital in Iceland. The participants will receive treatment as usual and the BA will be adjunctive. At least ten people, that are currently experiencing Bipolar Depression and are willing to take part, will receive up to 20 individual therapy sessions of BA that have been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews. The study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar depression, Bipolar Disorder, Behavioural Activation, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a case series using a multiple baseline design whereby participants are randomly allocated to one of 6 durations of wait at baseline before commencing treatment.
Masking
None (Open Label)
Masking Description
It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 week wait
Arm Type
Other
Arm Description
Participant waits for 2 weeks after their baseline assessment before commencing therapy.
Arm Title
3 week wait
Arm Type
Other
Arm Description
Participant waits for 3 weeks after their baseline assessment before commencing therapy.
Arm Title
4 week wait
Arm Type
Other
Arm Description
Participant waits for 4 weeks after their baseline assessment before commencing therapy.
Arm Title
5 week wait
Arm Type
Other
Arm Description
Participant waits for 5 weeks after their baseline assessment before commencing therapy.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Activation (BA)
Intervention Description
BA is based on the assumption that depression may be precipitated and is maintained by a reduction in "healthy", adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.
Primary Outcome Measure Information:
Title
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Description
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
through study completion, an average of 7 months
Title
Therapy uptake rate
Description
Number of participants randomised who attend at least 1 treatment session
Time Frame
through study completion, an average of 7 months
Title
Therapy completion rate
Description
Proportion of participants that attend at least 8 treatment sessions
Time Frame
through study completion, an average of 7 months
Title
Change in activity levels as measured by consumer connected health devices
Description
Measures of activity levels as by Withings health devices
Time Frame
through study completion, an average of 7 months
Title
Change in Sleep Duration measured by health device
Description
Measures of sleep duration by Withings health devices
Time Frame
through study completion, an average of 7 months
Title
No significant adverse reaction for participants
Description
Participant reports of adverse events elicited by researchers and therapists
Time Frame
through study completion, an average of 7 months
Secondary Outcome Measure Information:
Title
Altman Self-Rating Mania Scale (ASRM)
Description
5 item self-report measure of hypomania symptoms over the past week
Time Frame
1 week
Title
Work and Social Adjustment Scale (WSAS)
Description
5 item self-report scale of functional impairment attributable to an identified problem
Time Frame
24 hours
Title
Hamilton Depression Scale (HAM-D)
Description
17 item observer-rated scale measuring symptoms of depression over the past week
Time Frame
1 week
Title
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
Description
12 item self-report measure of disorder-specific quality of life
Time Frame
1 week
Title
General Anxiety Disorder Assessment - 7 (GAD7)
Description
7 item self-report measure of anxiety symptoms
Time Frame
2 weeks
Title
Behavioral Activation for Depression Scale (BADS)
Description
25 item self-report measure of changes in activation and avoidance over the past week
Time Frame
1 week
Title
Snaith-Hamilton Pleasure Scale (SHAPS)
Description
14 item self-report measure of level of anhedonia
Time Frame
1 week
Title
Mini International Neuropsychiatric Interview (MINI) 7.0.2
Description
Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence
Time Frame
Six months
Title
Young mania rating scale
Description
11 item observer-rated scale measuring the severity of manic states
Time Frame
48 hours
Title
Six daily questions
Description
Six daily questions in mobile about goal achievement, mood, sleep etc
Time Frame
24 hours
Title
The Quality of Behavioral Activation Scale (Q-BAS)
Description
To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Mini International Neuropsychiatric Interview (MINI) 7.0.2 meeting diagnostic criteria for Bipolar I or II Disorder (MINI) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator. Exclusion Criteria: current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali. currently lacking the capacity to give informed consent currently receiving other psychosocial therapy for depression or bipolar disorder presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halla Ó Ólafsdóttir, Cand. psych
Phone
8688371
Email
hallaosh@landspitali.is
First Name & Middle Initial & Last Name or Official Title & Degree
Brynja Bj Magnúsdóttir, PhD
Phone
8489685
Email
brynjabm@ru.is
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brynja B Magnúsdóttir, PhD
Organizational Affiliation
Reykjavik University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna S Islind, PhD
Organizational Affiliation
Reykjavik University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steinunn G Sigurðardóttir, MSc
Organizational Affiliation
Reykjavik University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landspitali university hospital
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halla Ó Ólafsdóttir, Cand. psych
Phone
003548688371
Email
hallaosh@landspitali.is
First Name & Middle Initial & Last Name & Degree
Brynja B Magnúsdóttir, PhD, cand psych
Phone
003548489685
Email
brynjabm@ru.is

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data that underlie results in a publication
IPD Sharing Time Frame
Access will be possible from the date of publication.
IPD Sharing Access Criteria
The dataset will be anonymous and registered with a metadata-only record, allowing the research team to control access to the dataset, and restricting it to appropriately qualified third parties.

Learn more about this trial

Behavioural Activation for Bipolar Depression

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