Evidence map›Paper›PMID 39934725›Full record

Trial reportBMC psychiatry2025

A randomized controlled trial of a therapist-guided online intervention for depressed adults and its utility as an adjunctive to antidepressants and psychotherapy.

Manuel Heinrich, Pavle Zagorscak, Christina Kampisiou, Johannes Bohn, Lars Schulze, Carmen Schaeuffele, Annette Brose, Christine Knaevelsrud

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Manuel HeinrichDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany. manuel.heinrich@fu-berlin.de.
Pavle ZagorscakDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Christina KampisiouDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Johannes BohnDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Lars SchulzeDepartment of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany.
Carmen SchaeuffeleDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Annette BroseDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Christine KnaevelsrudDepartment of Clinical-Psychological Intervention, Freie Universität Berlin, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInternet-based interventions (IBIs) are a low-threshold treatment for individuals with depression. However, comparisons of IBI against unstandardized care-as-usual (CAU) are scarce. Moreover, little evidence is available if IBI has an add-on effect for individuals already receiving an evidence-based treatment such as antidepressants and/or psychotherapy.

methodThis parallel, two-arm RCT (1:1 allocation ratio, simple randomization) examines the effectiveness of a therapist-guided cognitive-behavioral IBI compared to unstandardized CAU in a self-selected sample of adults (≥ 18 years). Eligible individuals reported (a) mild (BDI-II score ≥ 14) to moderately severe (PHQ-9 ≤ 19) symptoms of depression, (b) no acute suicidal ideations, (c) no acute or lifetime (hypo-)mania and/or symptoms of psychosis. We assigned eligible individuals to an intervention (INT) arm or an unstandardized CAU-arm (i.e., we imposed no restrictions on what individuals were allowed to do in the 8-week waiting period). Individuals in the INT-arm got access to a 7-module CBT-based IBI. The primary endpoint is depressive symptom load 9 to 11 weeks after randomization. Secondary endpoints included anxiety, self-efficacy, and perceived social support. We report effects for the entire sample (N = 1899), as well as for individuals using the IBI as a stand-alone intervention (n = 1408) or as an add-on to antidepressants (n = 367), psychotherapy (n = 73), or antidepressants and psychotherapy (n = 51). Patients entered the trial with these concurrent treatments (i.e., they were not randomly assigned).

resultsConcerning all randomized individuals, 62.5% of individuals in the INT-arm accessed all treatment modules within 11 weeks. Individuals assigned to the INT-arm reported significantly lower depressive symptoms (PHQ-9: - 2.5, 95% CI [- 2.9, - 2.0], d =  - 0.7; BDI-II: - 5.3, 95% CI [- 6.5, - 4.1], d =  - 0.8) and higher rates of  ≥ 50% symptom improvements (PHQ-9: 38.5% vs. 14.3%; BDI-II: 44.6% vs. 14.8%) compared to individuals assigned to the CAU-arm. Secondary outcomes also favored INT over CAU, with effect sizes ranging from |d|= 0.18 (social support) to 0.62 (anxiety). Rates of deterioration (PHQ-9: 4.1%; BDI-II: 3.4%) and self-reported side effects (10.5%) were low in the INT-arm. Similar patterns emerged for all strata. However, the between-arm differences failed to reach significance within the strata of individuals using the IBI as an add-on to psychotherapy.

conclusionOur results show that providing interested adults access to the therapist-guided, cognitive-behavioral IBI under investigation is associated with improved mental health outcomes, whether individuals use the IBI as a stand-alone or add-on intervention to another evidence-based treatment. This finding aligns with available studies indicating that IBIs should be considered a low-threshold treatment option for individuals with depression.

trial registrationThe trial was registered at the Deutsches Studienregister (Trial-Registriation Number/DRKS-ID: DRKS00021106, Date: 25.06.2020).

Indexed as

Antidepressive AgentsCognitive Behavioral TherapyDepressionInternet-Based InterventionPsychotherapyAdultCombined Modality TherapyFemaleHumansMaleMiddle AgedTreatment OutcomeAntidepressive AgentsAntidepressantsDepressionDigital interventioniCBTInternet-based Intervention (IBI)Randomized-controlled trial (RCT)Unstandardized care-as-usual (CAU)Waitlist

Identifiers

PMID39934725
PMCPMC11817706

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.