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Clinical Trials/NCT06023732
NCT06023732CompletedNot Applicable

Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression, A Single-case Study

Region Stockholm1 site in 1 country7 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
1
Primary Endpoint
Patient Health Questionnaire-2 (PHQ-2)

Study Overview

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. 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?

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • concurrent comorbid psychiatric problems assessed as primary to depression.

Arms & Interventions

Baseline 7 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 8 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 9 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 10 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 11 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 12 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 13 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Baseline 14 days

Experimental

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

Intervention: Behavioral activation and emotion-focused interventions (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • 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 follow up 12 months post intervention start)
  • Insomnia Severity Index (ISI)(Change from pre intervention to follow up 12 months post intervention start)
  • Generalized Anxiety Disorder 7-item scale (GAD-7)(Change from pre intervention to follow up 12 months post intervention start)
  • Client Satisfaction Questionnaire (CSQ-8)(Immediately post intervention)
  • Behavioral Activation for Depression Scale (BADS) short version 9 items(Change from pre intervention to follow up 12 months post intervention start)
  • The Work and Social Adjustment Scale (WSAS)(Change from pre intervention to follow up 12 months post intervention start)
  • Negative Effects Questionnaire (NEQ)(Immediately post intervention)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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