NCT06023732

Brief 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. 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. 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2025

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

August 28, 2023

Last Update Submit

May 6, 2026

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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)

    Change from pre intervention to post intervention (15 weeks post intervention start)

  • Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)

  • Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Change from pre intervention to follow up 6 months post intervention start

  • Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Change from pre intervention to follow up 12 months post intervention start

  • Patient Health Questionnaire (PHQ-9)

    Change from pre intervention to post intervention (15 weeks post intervention start)

  • +21 more secondary outcomes

Study Arms (8)

Baseline 7 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 8 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 9 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 10 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 11 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 12 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 13 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Baseline 14 days

EXPERIMENTAL

Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days

Behavioral: Behavioral activation and emotion-focused interventions

Interventions

Behavioral activation and emotion-focused interventionsBEHAVIORAL

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 daysBaseline 11 daysBaseline 12 daysBaseline 13 daysBaseline 14 daysBaseline 7 daysBaseline 8 daysBaseline 9 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • concurrent comorbid psychiatric problems assessed as primary to depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liljeholmens primary care centre

Stockholm, Sweden

Location

Related Publications (13)

  • Dugard P, File, P., Todman, J. Singel-case and Small-n experimental designs. New york: Routledge; 2001.

    BACKGROUND

  • 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.

    PMID: 14583691BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 11556941BACKGROUND

  • 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.

    PMID: 16717171BACKGROUND

  • 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.

    PMID: 11983645BACKGROUND

  • 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.

    PMID: 11438246BACKGROUND

  • 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.

    PMID: 27239096BACKGROUND

  • 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.

    PMID: 10259963BACKGROUND

  • 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.

    PMID: 30871650BACKGROUND

  • 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.

    PMID: 21324944BACKGROUND

  • Linehan MM. Cognitive Behavioral Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.

    BACKGROUND

  • Greenberg, Leslie S. and Goldman, Rhonda N. Clinical Handbook of Emotion-Focused Therapy. American Psychological Association. (2018).

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 5, 2023

Study Start

September 1, 2023

Primary Completion

October 7, 2024

Study Completion

October 21, 2025

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)