Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression
NCT ID: NCT06023732
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
7 participants
INTERVENTIONAL
2023-09-01
2025-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Research question and hypothesis
1. What is the effect of behavioural activation and emotion-focused interventions on patients' ratings of depressive symptoms, behavioural activation and emotion regulation difficulties?
2. 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?
3. 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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Behavioural Activation-Based Treatment Administered Through Smartphone
NCT01463020
Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context
NCT06415838
Effects of Behavioural Activation on Emotional Cognition and Mood
NCT03995186
Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety
NCT05157386
Behavioral Activation for the Treatment of Depression in Older Adults
NCT06284889
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baseline 7 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 8 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 9 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 10 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 11 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 12 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 13 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Baseline 14 days
Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
Behavioral activation and emotion-focused interventions
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Behavioral activation and emotion-focused interventions
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* have basic reading and writing skills in Swedish
* not express acute suicidal ideation
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region Stockholm
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liljeholmens primary care centre
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kanter 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.
Spitzer 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.
Mundt 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.
Bastien 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.
Bjureberg 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.
Attkisson 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.
Rozental 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.
Lejuez 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.
Linehan 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).
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ERDEP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.