DepressionNCT03299127
Imagery Rescripting in Depression
A study testing imagery rescripting in people with Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Depression is among the world's leading causes of disability. To fill the existing treatment gap, psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- imagery rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 15 Dec 2017
- 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
- Electronic informed consent
- Internet access
- Adequate command of the German language
- Diagnosis of depression (primary or secondary)
Who cannot join
- Acute suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms
Depression is among the world's leading causes of disability. To fill the existing treatment gap, psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach. The present trial aims to evaluate imagery rescripting. With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II.
Read the detailed description
Depression is among the world's leading causes of disability. Effective pharmacological and psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive symptoms receive proper treatment (Kohn, Saxena, Levav, \& Saraceno, 2004). To fill the existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach (i.e., "foot in the door") for persons who have reservations about face-to-face psychotherapy. E-mental health and bilbiotherapeutic interventions have yielded promising results, but there remains room for improvement as effect sizes are usually in the small to medium range. The present trial aims to evaluate imagery rescripting, a technique developed by Smucker (Smucker, Dancu, Foa, \& Niederee, 1995). With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". Positive mental imagery strategies seek to hold negative mental images in check and impart the patient with a feeling of self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on anxiety and depressive symptoms across a range of disorders (Morina, Lancee, \& Arntz, 2017).
To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. At post-assessment, the (full-length) manual will be made available to all participants. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global item from the WHOQOL-BREF). The project may help to answer the question of whether imagery rescripting is effective when presented using a self-help medium.
- Conditions
- Depression
- Being tested
- imagery rescripting
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagery rescriptingBehavioural
The long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a "happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride.
| Study group | Role | What they receive |
|---|---|---|
| imagery rescripting | Experimental | bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version) Receives: Behavioral: imagery rescripting |
| wait-list control | No intervention | wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory II
Beck Depression Inventory II (BDI II) (Beck, Steer, \& Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.
Measured: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a self-administered scale derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) and measures depression according to the nine depression items of the DSM-IV.
Measured: Change from pre- to post-intervention (i.e. 6 week interval)
Rosenberg Self-Esteem Scale (RSE)
The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.
Measured: Change from pre- to post-intervention (i.e. 6 week interval)
Generalized Anxiety Disorders 7 (GAD-7)
The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.
Measured: Change from pre- to post-intervention (i.e. 6 week interval)
Global item of the WHO Quality of Life scale (WHOQOL-BREF)
The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.
Measured: Change from pre- to post-intervention (i.e. 6 week interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Apr 2017
- Primary completion30 Jul 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Parallel groups
- Model description
- randomized-controlled trial, wait-list control condition
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Moritz, PhD, Principal investigator, UKE Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299127
- Sponsor's protocol ID
- IR-Phoenix
- Status last verified
- Jun 2018
- First submitted
- 27 Sep 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.
PubMed 29597112
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms
- ClinicalTrials.gov ID
- NCT03299127
- Acronym / sponsor ID
- IR-Phoenix
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Oct 2017 (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.
Depression is among the world's leading causes of disability. To fill the existing treatment gap, psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach. The present trial aims to evaluate imagery rescripting. With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II.
Detailed description
Depression is among the world's leading causes of disability. Effective pharmacological and psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive symptoms receive proper treatment (Kohn, Saxena, Levav, \& Saraceno, 2004). To fill the existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach (i.e., "foot in the door") for persons who have reservations about face-to-face psychotherapy. E-mental health and bilbiotherapeutic interventions have yielded promising results, but there remains room for improvement as effect sizes are usually in the small to medium range. The present trial aims to evaluate imagery rescripting, a technique developed by Smucker (Smucker, Dancu, Foa, \& Niederee, 1995). With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". Positive mental imagery strategies seek to hold negative mental images in check and impart the patient with a feeling of self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on anxiety and depressive symptoms across a range of disorders (Morina, Lancee, \& Arntz, 2017).
To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. At post-assessment, the (full-length) manual will be made available to all participants. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global item from the WHOQOL-BREF). The project may help to answer the question of whether imagery rescripting is effective when presented using a self-help medium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized-controlled trial, wait-list control condition
| Arm | Type | Receives |
|---|---|---|
| imagery rescripting | Experimental | Behavioral: imagery rescriptingbibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version) |
| wait-list control | No intervention | –wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Electronic informed consent
- Internet access
- Adequate command of the German language
- Diagnosis of depression (primary or secondary)
Key exclusion criteria (1 listed)
- Acute suicidality
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 |
|---|---|---|
| imagery rescriptingThe long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a "happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride. | Behavioural | imagery rescripting |
Primary outcome
Beck Depression Inventory II
Time frame: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
Beck Depression Inventory II (BDI II) (Beck, Steer, \& Brown, 1996). The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression. A follow-up assessment after six month serves as secondary outcome.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Change from pre- to post-intervention (i.e. 6 week interval)
Rosenberg Self-Esteem Scale (RSE)
Time frame: Change from pre- to post-intervention (i.e. 6 week interval)
Generalized Anxiety Disorders 7 (GAD-7)
Time frame: Change from pre- to post-intervention (i.e. 6 week interval)
Global item of the WHO Quality of Life scale (WHOQOL-BREF)
Time frame: Change from pre- to post-intervention (i.e. 6 week interval)
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 13 Jun 2018.
- Results publication: PubMed 29597112Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.
- Individual participant dataSharing planned: Undecided
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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.
Steffen Moritz, PhD principal investigator
UKE Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imagery rescripting in people with Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 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 13 Jun 2018. 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 Germany. 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?
Beck Depression Inventory II (time frame: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)). 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 NCT03299127, which also lists 1 linked publication.
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 13 Jun 2018.