DepressionNCT06023732
Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression
A study testing Behavioral activation and emotion-focused interventions in people with Depression, run by Region Stockholm at 1 site in Sweden.
Trial summary
The study is a single-case intervention study, evaluating effects of the treatment Behavioral activation and emotion-focused interventions for depression. Research question and hypothesis 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral activation and emotion-focused interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 21 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet diagnostic criteria for depression as their primary problem according to DSM-5
- have basic reading and writing skills in Swedish
- not express acute suicidal ideation
Who cannot join
- concurrent comorbid psychiatric problems assessed as primary to depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression, A Single-case Study
The study is a single-case intervention study, evaluating effects of the treatment Behavioral activation and emotion-focused interventions for depression.
Research question and hypothesis
- What is the effect of behavioural activation and emotion-focused interventions on patients' ratings of depressive symptoms, behavioural activation and emotion regulation difficulties?
- What is the effect of behavioural activation and emotion-focused interventions on patients' overall psychiatric state, with regards to ratings of anxiety, quality of life, level of functioning?
- How does patient ratings of behavioural activation and emotion regulation difficulties and skills change during the course of treatment, in relation to treatment/session content?
Read the detailed description
Procedure The study will be carried out by the authors or experienced clinicians (master level students at the Psychotherapy program at the Karolinska Institute), recruiting and treating patients with recurring depression at a primary care unit in the Stockholm region. 7 patients will be treated during 15 weeks. The treatment will be carried out in a blended format with an internet-based treatment supported with therapist face-to-face sessions. The initial behavioural activation phase lasts up to 6 weeks followed by additional emotion focused interventions. The treatment is initiated by a therapist session, thereafter therapist sessions are planned approximately every 3rd week.
To be included in the study participants must meet diagnostic criteria for depression as their primary problem according to DSM-5 (Diagnostic and Statistical Manual), have basic reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with concurrent co-morbid psychiatric problems are eligible for inclusion unless another psychiatric diagnosis is assessed as primary to depression. Patients will be recruited from the regular flow of patients who seek treatment for psychological problems in the selected clinic. If interested they will be contacted by the study therapists and screened and assessed for eligibility after signing an informed consent.
Participants meeting inclusion criteria and not exclusion criteria will be offered participation in the study, and randomized to one of the 7 baseline lengths.
Methodology/approach/data analysis The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms. The B-phase will last 15 weeks and include the full internet-based treatment supported with 5-10 face-to-face therapist sessions .
Single-case experimental design (SCED) is particularly useful when evaluating a novel treatment in a clinical context as it produces reliable results even with a small sample size. Also, it is particularly helpful for studying the details of how the intervention works for each individual patient, through detailed and repeated measures of several dependent variables and processes. It is recommended that the effect of the intervention is assessed in at least 3 individuals (1), however, we will recruit at least 7 participants to allow for higher statistical power and as a safety measure for drop out and missing data.
Primary treatment effects in terms of depression, behavioural activation and emotion regulation will be assessed daily from day of inclusion to end of follow-up, with brief versions of self-rated measures with good reliability and validity. Brief versions of the following scales will be used for the daily assessment; depressive symptoms PHQ-2 (2), difficulties in emotion regulation, and daily behavioural activation BADS (3). Longitudinal data will be analyzed with non-parametric statistical tests (1). Visual inspection will be used to analyse variability, trends and patterns of change in the daily assessments over the phases of treatment.
Kendal's Tau is a non-overlap statistical test that has been developed for analysing SCED time series data with adequate statistical power. It will be used to analyse statistical differences in the dependent variables between phases. Kendal's Tau will be complemented with Tau-U tests if there are statistical trends in the data-series. Statistical power is very difficult to calculate for this test but given the expected medium effect sizes of the interventions and the replication across five participants, the statistical power is assessed as adequate. Pre, post and follow-up data will be assessed at start of phase A, start of phase B, after phase B and at follow up 3 months post treatment. The measures used will be PHQ-9 (4) for depression, GAD-7 (5) for anxiety symptoms, WSAS (6) for disability and ISI (7) for symptoms of insomnia. To measure if the treatment affects emotion regulation, self-ratings of DERS 16 (8) will be used. Post treatment the CSQ-8 (9) will be used to assess treatment satisfaction and NEQ (10) to asses negative effects.
- Conditions
- Depression
- Being tested
- Behavioral activation and emotion-focused interventions
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activation and emotion-focused interventionsBehavioural
Behavioral activation with emotion-focused interventions comprises two consecutive phases. In the first phase, treatment focus is behavioral activation in line with Brief behavioral activation treatment for depression - revised (BATD-R; 11) During the second phase, treatment focus shifts to address participants' emotions. Difficulties in understanding, tolerating, and labeling emotions is addressed by observing and describing emotions (12). Under the guidance of the therapist, participants are instructed to explore emotions normally avoided or ruminated on. This is conceptualized as a form of exposure to aversive emotions, thoughts and memories, to initiate emotional processing (13).
| Study group | Role | What they receive |
|---|---|---|
| Baseline 7 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 8 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 9 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 10 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 11 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 12 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 13 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
| Baseline 14 days | Experimental | Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days Receives: Behavioral: Behavioral activation and emotion-focused interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-2 (PHQ-2)
The PHQ-2 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 6. Higher scores indicating more symptoms. The items correspond to the core criteria for depression in the DSM-IV.
The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps are scored from 0 to 3 and summed.
Measured: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
2 item Behavioral Activation for Depression Scale (BADS)
The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. The 2 most central items concerning rumination and behavioral activation are chosen and rated 0-6 from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-12.
Measured: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
Emotion Regulation
2 items regarding self rated emotion regulation. Items: Today I have been able to understand my emotions and needs, Today I have been able to accept my emotions and needs are rated from 1-5 where 1= Almost never and 5= Almost always. Total score ranges from 2-10 where higher scores indicate more sufficient emotion regulation.
Measured: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
Secondary outcomes (26)
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
Measured: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
Measured: Change from pre intervention to follow up 6 months post intervention start
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
Measured: Change from pre intervention to follow up 12 months post intervention start
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Measured: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Measured: Change from pre intervention to post intervention follow up 6 months post intervention start
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Measured: Change from pre intervention to follow up 12 months post intervention start
Behavioral Activation for Depression Scale (BADS) short version 9 items
The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
Behavioral Activation for Depression Scale (BADS) short version 9 items
The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
Measured: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Behavioral Activation for Depression Scale (BADS) short version 9 items
The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
Measured: Change from pre intervention to follow up 6 months post intervention start
Behavioral Activation for Depression Scale (BADS) short version 9 items
The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
Measured: Change from pre intervention to follow up 12 months post intervention start
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
Measured: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
Measured: Change from pre intervention to follow up 6 months post intervention start
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
Measured: Change from pre intervention to follow up 12 months post intervention start
Insomnia Severity Index (ISI)
A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
Insomnia Severity Index (ISI)
A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
Measured: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Insomnia Severity Index (ISI)
A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
Measured: Change from pre intervention to follow up 6 months post intervention start
Insomnia Severity Index (ISI)
A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
Measured: Change from pre intervention to follow up 12 months post intervention start
The Work and Social Adjustment Scale (WSAS)
The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
Measured: Change from pre intervention to post intervention (15 weeks post intervention start)
The Work and Social Adjustment Scale (WSAS)
The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
Measured: Change from pre intervention to post post Behavioral activation phase (5 weeks post intervention start)
The Work and Social Adjustment Scale (WSAS)
The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
Measured: Change from pre intervention to follow up 6 months post intervention start
The Work and Social Adjustment Scale (WSAS)
The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
Measured: Change from pre intervention to follow up 12 months post intervention start
Client Satisfaction Questionnaire (CSQ-8)
Self rated questionnaire to rate satisfaction with treatment. 8 items rated from 1-4 and summarized. Lower scores indicating less satisfaction. Scale ranging from 0-32
Measured: Immediately post intervention
Negative Effects Questionnaire (NEQ)
self-rating form to measure negative effects of psychological treatment The NEQ consists of 20 statements that are answered on a 0-4 Likert scale. Furthermore, there is an open question to try to capture such negative effects that are not included in the self-report form, but which may be of theoretical or clinical relevance. In addition, the respondent is asked to answer whether the negative effects experienced were due to the treatment they underwent or other circumstances. The scale ranges from 0-80, higher scores indicate more negative effects. However the scale is more descriptive than designed to calculate negative effects
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Sep 2023
- Primary completion7 Oct 2024
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Single group
- Model description
- The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023732
- Sponsor's protocol ID
- ERDEP
- Status last verified
- May 2026
- First submitted
- 28 Aug 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dugard P, File, P., Todman, J. Singel-case and Small-n experimental designs. New york: Routledge; 2001.
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
PubMed 14583691Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): Psychometric Properties and Factor Structure. Journal of Psychopathology and Behavioral Assessment. 2006;29(3):191.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
PubMed 27239096Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
PubMed 30871650Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
PubMed 21324944Linehan MM. Cognitive Behavioral Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.
Greenberg, Leslie S. and Goldman, Rhonda N. Clinical Handbook of Emotion-Focused Therapy. American Psychological Association. (2018).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression, A Single-case Study
- ClinicalTrials.gov ID
- NCT06023732
- Acronym / sponsor ID
- ERDEP
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 5 Sep 2023 (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.
The study is a single-case intervention study, evaluating effects of the treatment Behavioral activation and emotion-focused interventions for depression.
Research question and hypothesis
- What is the effect of behavioural activation and emotion-focused interventions on patients' ratings of depressive symptoms, behavioural activation and emotion regulation difficulties?
- What is the effect of behavioural activation and emotion-focused interventions on patients' overall psychiatric state, with regards to ratings of anxiety, quality of life, level of functioning?
- How does patient ratings of behavioural activation and emotion regulation difficulties and skills change during the course of treatment, in relation to treatment/session content?
Detailed description
Procedure The study will be carried out by the authors or experienced clinicians (master level students at the Psychotherapy program at the Karolinska Institute), recruiting and treating patients with recurring depression at a primary care unit in the Stockholm region. 7 patients will be treated during 15 weeks. The treatment will be carried out in a blended format with an internet-based treatment supported with therapist face-to-face sessions. The initial behavioural activation phase lasts up to 6 weeks followed by additional emotion focused interventions. The treatment is initiated by a therapist session, thereafter therapist sessions are planned approximately every 3rd week.
To be included in the study participants must meet diagnostic criteria for depression as their primary problem according to DSM-5 (Diagnostic and Statistical Manual), have basic reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with concurrent co-morbid psychiatric problems are eligible for inclusion unless another psychiatric diagnosis is assessed as primary to depression. Patients will be recruited from the regular flow of patients who seek treatment for psychological problems in the selected clinic. If interested they will be contacted by the study therapists and screened and assessed for eligibility after signing an informed consent.
Participants meeting inclusion criteria and not exclusion criteria will be offered participation in the study, and randomized to one of the 7 baseline lengths.
Methodology/approach/data analysis The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms. The B-phase will last 15 weeks and include the full internet-based treatment supported with 5-10 face-to-face therapist sessions .
Single-case experimental design (SCED) is particularly useful when evaluating a novel treatment in a clinical context as it produces reliable results even with a small sample size. Also, it is particularly helpful for studying the details of how the intervention works for each individual patient, through detailed and repeated measures of several dependent variables and processes. It is recommended that the effect of the intervention is assessed in at least 3 individuals (1), however, we will recruit at least 7 participants to allow for higher statistical power and as a safety measure for drop out and missing data.
Primary treatment effects in terms of depression, behavioural activation and emotion regulation will be assessed daily from day of inclusion to end of follow-up, with brief versions of self-rated measures with good reliability and validity. Brief versions of the following scales will be used for the daily assessment; depressive symptoms PHQ-2 (2), difficulties in emotion regulation, and daily behavioural activation BADS (3). Longitudinal data will be analyzed with non-parametric statistical tests (1). Visual inspection will be used to analyse variability, trends and patterns of change in the daily assessments over the phases of treatment.
Kendal's Tau is a non-overlap statistical test that has been developed for analysing SCED time series data with adequate statistical power. It will be used to analyse statistical differences in the dependent variables between phases. Kendal's Tau will be complemented with Tau-U tests if there are statistical trends in the data-series. Statistical power is very difficult to calculate for this test but given the expected medium effect sizes of the interventions and the replication across five participants, the statistical power is assessed as adequate. Pre, post and follow-up data will be assessed at start of phase A, start of phase B, after phase B and at follow up 3 months post treatment. The measures used will be PHQ-9 (4) for depression, GAD-7 (5) for anxiety symptoms, WSAS (6) for disability and ISI (7) for symptoms of insomnia. To measure if the treatment affects emotion regulation, self-ratings of DERS 16 (8) will be used. Post treatment the CSQ-8 (9) will be used to assess treatment satisfaction and NEQ (10) to asses negative effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms.
| Arm | Type | Receives |
|---|---|---|
| Baseline 7 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 8 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 9 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 10 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 11 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 12 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 13 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
| Baseline 14 days | Experimental | Behavioral: Behavioral activation and emotion-focused interventionsBehavioral activation and emotion-focused interventions Baseline randomized length 7-14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet diagnostic criteria for depression as their primary problem according to DSM-5
- have basic reading and writing skills in Swedish
- not express acute suicidal ideation
Key exclusion criteria (1 listed)
- concurrent comorbid psychiatric problems assessed as primary to depression.
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 |
|---|---|---|
| Behavioral activation and emotion-focused interventionsBehavioral activation with emotion-focused interventions comprises two consecutive phases. In the first phase, treatment focus is behavioral activation in line with Brief behavioral activation treatment for depression - revised (BATD-R; 11) During the second phase, treatment focus shifts to address participants' emotions. Difficulties in understanding, tolerating, and labeling emotions is addressed by observing and describing emotions (12). Under the guidance of the therapist, participants are instructed to explore emotions normally avoided or ruminated on. This is conceptualized as a form of exposure to aversive emotions, thoughts and memories, to initiate emotional processing (13). | Behavioural | Baseline 10 days, Baseline 11 days, Baseline 12 days, Baseline 13 days, Baseline 14 days, Baseline 7 days, Baseline 8 days, Baseline 9 days |
Primary outcome
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
The PHQ-2 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 6. Higher scores indicating more symptoms. The items correspond to the core criteria for depression in the DSM-IV. The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps are scored from 0 to 3 and summed.
2 item Behavioral Activation for Depression Scale (BADS)
Time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. The 2 most central items concerning rumination and behavioral activation are chosen and rated 0-6 from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-12.
Emotion Regulation
Time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
2 items regarding self rated emotion regulation. Items: Today I have been able to understand my emotions and needs, Today I have been able to accept my emotions and needs are rated from 1-5 where 1= Almost never and 5= Almost always. Total score ranges from 2-10 where higher scores indicate more sufficient emotion regulation.
26 secondary outcomes
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Time frame: Change from pre intervention to follow up 6 months post intervention start
Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
Time frame: Change from pre intervention to follow up 12 months post intervention start
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre intervention to post intervention follow up 6 months post intervention start
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre intervention to follow up 12 months post intervention start
Behavioral Activation for Depression Scale (BADS) short version 9 items
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
Behavioral Activation for Depression Scale (BADS) short version 9 items
Time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Behavioral Activation for Depression Scale (BADS) short version 9 items
Time frame: Change from pre intervention to follow up 6 months post intervention start
Behavioral Activation for Depression Scale (BADS) short version 9 items
Time frame: Change from pre intervention to follow up 12 months post intervention start
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from pre intervention to follow up 6 months post intervention start
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from pre intervention to follow up 12 months post intervention start
Insomnia Severity Index (ISI)
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
Insomnia Severity Index (ISI)
Time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
Insomnia Severity Index (ISI)
Time frame: Change from pre intervention to follow up 6 months post intervention start
Insomnia Severity Index (ISI)
Time frame: Change from pre intervention to follow up 12 months post intervention start
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from pre intervention to post post Behavioral activation phase (5 weeks post intervention start)
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from pre intervention to follow up 6 months post intervention start
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from pre intervention to follow up 12 months post intervention start
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Immediately post intervention
Negative Effects Questionnaire (NEQ)
Time frame: Immediately post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- BackgroundDugard P, File, P., Todman, J. Singel-case and Small-n experimental designs. New york: Routledge; 2001.
- Background: PubMed 14583691Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- BackgroundKanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): Psychometric Properties and Factor Structure. Journal of Psychopathology and Behavioral Assessment. 2006;29(3):191.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 27239096Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Background: PubMed 30871650Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
- Background: PubMed 21324944Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
- BackgroundLinehan MM. Cognitive Behavioral Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation and emotion-focused interventions in people with Depression, run by Region Stockholm at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-2 (PHQ-2) (time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023732, which also lists 13 linked publications.
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 11 May 2026.